Randomized phase II trial of preoperative fulvestrant with or without enzalutamide in ER+/HER2- breast cancer
VIEW TRIAL ON CLINICALTRIALS.GOVBreast cancer, Hormone receptor positive breast cancer, locally advanced BC
Stage 2
Phase 2
Open to Enrollment
N/A
Enzalutamide and fulvestrant
Androgen receptor inhibitor
Greg Vidal, MD, PhD
University of Colorado, Department of Defense
ER positive, HER2 negative
- ER positive breast cancer
- Tumor stage at least T2
- Plan to receive local surgery
- Post-menopausal or if premenopausal will need to have concurrent ovarian suppression
- ECOG PS 0-2
- No history of seizures
- Not on full dose anticoagulation
- No prior treatment with anti-androgen agents
- No history of CNS metastases
Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant Neratinib and Chemotherapy in Early Stage Triple-Negative Breast Cancer Patients Who Exhibit Enhanced HER2 Signaling by Live Cell HER2 Signaling Transduction Analysis (FACT-2)
VIEW TRIAL ON CLINICALTRIALS.GOVBreast, Triple Negative Breast Cancer
Stage 2
Phase 2
Open to Enrollment
Neoadjuvant
Neratinib
HER2 targeted small molecule
Greg Vidal, MD, PhD
West Cancer Center, Puma Biotechnology, Celcuity
ER negative, PR negative, HER2 negative
- T1c or T2, cN0 or cN1 early breast cancer with plans for surgical resection
- ER/PR <10%, HER2 negative
- ECOG PS 0-1
- ANC >1200, Hgb >10, Plt >100,000
- Tumor determined to have abnormal HER2-driven signaling activity based on the CELx HSF test (to be conducted during screening)
- No T3 or T4 tumors
- No definitive surgical treatment performed yet
- No evidence of metastatic disease
- No prior history of ipsilateral DCIS or breast cancer
- No prior therapy with anthracyclines, taxanes, or anti-HER2 therapy
- No other malignancies within 2 years prior
- No active cardiac disease
- No uncontrolled hypertension
- No known HIV/HBV/HCV
- No neuropathy grade >=2
RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction
VIEW TRIAL ON CLINICALTRIALS.GOVBreast cancer
Stage 2
Phase 3
Open to Enrollment
Adjuvant
Hypofractionated radiotherapy
Radiation
Noam VanderWalde, MD
Alliance for Clinical Trials in Oncology
Invasive ductal, invasive lobular, tubular
- Invasive breast cancer (ductal, lobular, tubular, mammary, medullary)
- If received neoadjuvant therapy, pre treatment staging must have N1 or N2 disease pre-chemo or are T3N0
- If did not receive neoadjuvant, must be T0N1-2a, T1N1-2a, T2N1-2a, or T3N0-2a.
- No prior therapeutic radiation to the chest, neck, or axilla
- No prior history of ipsilateral breast cancer
- DCIS or LCIS are allowed
- Negative margins following mastectomy
- No significant post mastectomy complications in the ipsilateral breast requiring unplanned re-operation or admission for IV antibiotics.
- Reoperation for margins or lymph node dissection is allowed
- Radiation oncologist is NOT planning to use a chest wall/scar boost
- Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements
- No co-existing medical conditions with a life expectancy <5 years
- ECOG PS 0-1
A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy
VIEW TRIAL ON CLINICALTRIALS.GOVBreast Cancer, Early Breast Cancer, Node-positive breast cancer
Stage 2
Phase 3
Open to Enrollment
Post-neoadjuvant
N/A
N/A
Richard Fine, MD
Alliance for Clinical Trials in Oncology
Node-positive any histology
- Stage T1-3 N1 M0 at diagnosis (prior to start of neoadjuvant chemotherapy)
- No inflammatory breast cancer
- No other malignancy within 5 years
- Must have received axillary ultrasound with bx or axillary lymph nodes prior to or within 14 days of starting neoadjuvant therapy
- Must have documented ER/PR/HER2 status before neoadjuvant therapy
- Must have completed all planned chemotherapy prior to trial (ie. no planned adjuvant therapy)
- Must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane based regimen
- HER2 positive patients must have received anti-HER2 therapy as part of neoadjuvant regimen
- Must have clinically negative axilla documented on physical exam at the completion of neoadjuvant chemotherapy (no imaging needed)
- No neoadjuvant endocrine or radiation therapy
- No history of prior breast cancer
- ECOG PS 0-1
- Must complete surgery within 56 days of finish of neoadjuvant therapy
- At least 1 sentinel lymph node identified intra-operatively with at least micromets
Breast Cancer, Early Breast Cancer, Node-positive breast cancer
Stage 2
Phase 3
Open to enrollment
Post-neoadjuvant
regional nodal irradiation
N/A
Noam VanderWalde, MD
NSABP Foundation
Node positive prior to surgery, pathologically node negative at surgery
-
Patients must have pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on a positive FNA (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma). Patients may not have had documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy).
-
Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant chemotherapy)
-
Hormone receptor status must be performed on the primary breast tumor before neoadjuvant chemotherapy.
-
HER2 status must be performed on the primary breast tumor before neoadjuvant chemotherapy. Patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible)
-
Patients must have completed a minimum of 8 weeks of standard neoadjuvant chemoterahyp consisting of an anthracycline and/or taxane-based regimen
-
For patients who receive adjuvant chemotherapy after surgery a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization
-
Patients with HER2-positive tumors must have received neoadjuvant anti-HER2 therapy (with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated.
-
At the time of definitive surgery, all removed axillary nodes must be histologically free of cancer
-
ECOG PS 0-1
A Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
VIEW TRIAL ON CLINICALTRIALS.GOVBreast cancer
Stage 4
Phase 3
Open to Enrollment
1st line (pre-chemo)
GDC-9545
Selective estrogen receptor degrader (SERD)
Greg Vidal, MD, PhD
Hoffmann-LaRoche
ER+ (positive), HER2 - (negative)
- Postmenopausal or pre-menopausal but treated with LHRH agonist therapy for the duration of study treatment
- Locally advanced or metastatic adenocarcinoma of the breast not curable
- Documented ER-positive and HER2-negative
- No prior systemic anti-cancer therapy for metastatic disease
- Measurable disease
- ECOG PS 0-1
- No disease recurrence within 12 months of treatment with an AI or a CDK4/6 inhibitor in adjuvant/neoadjuvant setting
- No prior SERD
- No active CNS disease
A Phase 1 Study of MK-5890 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
VIEW TRIAL ON CLINICALTRIALS.GOVBreast, Triple Negative Breast Cancer, TNBC
Stage 4
Phase 1
Open to Enrollment
2nd or 3rd line
MK-5890
CD27 agonist
Dan Vaena, MD
Merck Sharp & Dohme Corp
ER negative, PR negative, HER2 negative
- Must have measurable disease by RECIST 1.1
- Diagnosis of TNBC
- Must have received or been intolerant to not more than 2 lines of therapy for metastatic disease
- Prior therapy should have included anthracycline and/or taxane
- LDH must be <2x ULN at screening
- May be PD-L1 treatment refractory (number capped)
- ECOG PS 0-1
- No 2nd malignancy within 2 years
- No active CNS involvement
- No history of interstitial lung disease
- No active pneumonitis or history of non-infectious pneumonitis that required steroids
- No active autoimmune disease that required systemic tx in past 2 years (other than replacement therapy)
- No known HIV, HBV, HCV
- No need for steroids at dose of greater than 10mg prednisone or equivalent daily
- No recent history of substance abuse
An Open-Label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2− Breast Cancer With an ESR1 Mutation
VIEW TRIAL ON CLINICALTRIALS.GOVBreast cancer, invasive breast cancer, BC, hormone receptor positive BC
Stage 4
Phase 2
Open to Enrollment
2nd Line or later endocrine tx
Lasofoxifene
SERM
Lee Schwartzberg, MD
Sermonix Pharmaceuticals LLC
ER positive, HER2 negative
- Postmenopausal women with locally advanced or metastatic breast cancer
- Progression on an aromatase inhibitor (AI) in combination with a CDK4/6 inhibitor
- Demonstrated prior sensitivity to endocrine therapy (recurrence or progression after at least 12 months of treatment in metastatic setting)
- Measurable or non-measurable disease allowed
- One of the following ESR point mutations in cell-free DNA:
- Y537S, Y537C, D538G, E380Q, S463P, V534E, P535H, L536H, L536P, L536R, L536Q, or Y537N
- May have received up to one chemothearpy regimen in adjuvant or neoadjuvant setting
- ECOG PS 0-1
- No prior use of any SERM with following exception
- OK if tamoxifen previously used in adjuvant setting with relapse at least 1 year after stopping tamoxifen
- No prior everolimus or PI3K inhibitors
- No presence of CNS disease
- No immediate need for chemotherapy
- No HIV, HBV, HCV
- No prior malignancy in last 5 years except non-melanoma skin cancer or early stage cervical cancer
- No uncontrolled HTN
A Multicenter, Phase 2 Study of Tesetaxel Plus 3 Different PD-(L)1 Inhibitors in Patients With Metastatic TNBC and Tesetaxel Monotherapy in Elderly Patients With HER2 Negative MBC
VIEW TRIAL ON CLINICALTRIALS.GOVBreast cancer, triple-negative breast cancer, TNBC
Stage 4
Phase 2
Open to Enrollment
1st Line
Tesetaxel, nivolumab, pembrolizumab, atezolizumab
oral taxane, PD-1 or PD-L1 inhibitors
Lee Schwartzberg, MD
Odonate Therapeutics, Inc.
ER negative, PR negative, HER2 negative
- ER -, PR-, HER2 - biopsy proven breast cancer
- Locally advanced (not curable by surgery or radiation) or metastatic
- No prior chemotherapy for metastatic disease
- (Neo)Adjuvant therapy allowed if disease free interval of at least 12 months after completion
- No prior therapy with PD-1, PD-L1, or CTLA-4 inhibitors
- Tissue available for PD-1 level determination
- ECOG PS 0-2
- No known HIV/HBV/HCV
- No history of active autoimmune disease
- No Grade 2 or higher neuropathy
A Phase 1b/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy And Safety Of Multiple Immunotherapy-Based Treatment Combinations In Patients With Metastatic Triple-Negative Breast Cancer
VIEW TRIAL ON CLINICALTRIALS.GOVBreast, Triple Negative Breast Cancer, TNBC
Stage 4
Phase 1
Open to Enrollment
2nd Line
Atezolizumab with Ipatasertib or ladiratuzumab-vidotin or Bevacizumab or Cobimetinib or Capecitabine or Combination Chemo
PD-L1 antibody with either PI3Ki or LIV1A ADC or MEKi or VEGFRi or chemo
Greg Vidal, MD, PhD
Hoffman-La Roche
ER- (negative), PR- (negative), HER2- (negative)
- Triple negative metastatic breast cancer
- 2nd line
- ECOG PS 0-2
- No prior treatment with any study agents
- No history of autoimmune disease
- Presence of measurable disease
- No symptomatic or untreated CNS disease
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm A: Entrectinib in patients with ROS1 fusion-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVBreast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Ideally 1st line, but can be later line as well
Entrectinib
TKI against NTRK, ROS, and ALK
Axel Grothey, MD
Genentech, Inc.
ROS1 fusion. Any cancer type except not NSCLC
- Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
- Positive biomarker results from a CLIA certified lab, either tissue or blood sample
- ROS1 gene fusion positivity
- No non-small lung cancer (NSCLC)
- ECOG PS 0-2
- No symptomatic CNS metastases
- No known HIV/HBV/HCV
- No other malignancy within 3 years of study
- No prior treatment with crizotinib
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: ArmB: GDC-0077 in patients with PI3K activating mutation-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVBreast, Lung (NSCLC), Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Any line
GDC-0077
PI3K p110 alpha inhibitor
Axel Grothey, MD
Genentech, Inc.
PIK3CA mutation positive. Any malignancy except NOT CNS tumors
- Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
- Positive biomarker results from a CLIA certified lab, either tissue or blood sample
- No primary CNS malignancy
- One of the following PIK3CA mutations:
- R88Q
- G106A/D/R/S/V
- K111N/R/E
- G118D
- N345D/H/I/K/S/T/Y
- C420R
- E453A/D/G/K/Q/R/V
- E542A/D/G/K/Q/R/V
- E545A/D/G/K/L/Q/R/V
- Q546E/H/L/P/R
- M1043I/T/V
- H1047D/I/L/M/P/Q/R/T/Y
- G1049A/C/D/R/S
- Others only with study medical monitor approval
- ECOG PS 0-2
- No symptomatic CNS metastases
- No known HIV/HBV/HCV
- No other malignancy within 3 years of study
- No anti-hyperglycemic medication (no treated T2DM or T1DM)
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: ArmC: Alectinib in patients with ALK rearrangement-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVBreast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Any line
Alectinib
ALK and RET inhibitor
Axel Grothey, MD
Genentech, Inc.
ALK rearrangement/fusion in any malignancy except not NSCLC
- Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
- Positive biomarker results from a CLIA certified lab, either tissue or blood sample
- Not Non-small cell lung cancer (NO NSCLC)
- ALK gene fusion positivety defined as a 3' AALK fusion with a protein coding 5' gene fusion partner, predicted to be in frame with an intact kinase domain
- ECOG PS 0-2
- No symptomatic CNS metastases
- No known HIV/HBV/HCV
- No other malignancy within 3 years of study
- No prior treatment with crizotinib
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVAny: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Any line
Ipatasertib
AKT inhibitor
Axel Grothey, MD
Genentech, Inc.
PTEN loss or loss of function
- Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
- Positive biomarker results from a CLIA certified lab, either tissue or blood sample
- Either PTEN protein loss as determined by a CLIA or equivalently certified immunohistochemistry assay OR
- PTEN loss of function defined as PTEN dominant negative missense mutations or deleterious in-frame and missense mutations affecting protein function
- ECOG PS 0-2
- No symptomatic CNS metastases
- No known HIV/HBV/HCV
- No other malignancy within 3 years of study
- No prior treatment with crizotinib
- No insuline dependent diabetes
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression pattersn predictive of response: Arm D: Ipatasertib in patients with PTEN Loss/Loss-of-function or AKT activating mutation-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVAny: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Any line
Ipatasertib
AKT inhibitor
Axel Grothey, MD
Genentech, Inc.
select AKT mutations
- Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
- Positive biomarker results from a CLIA certified lab, either tissue or blood sample
- One of the following mutations in AKT:
- AKT 1 : E17K, L52R, or Q79K
- AKT 2 : E17K
- AKT 3: E17K, L51R, or Q78K
- ECOG PS 0-2
- No symptomatic CNS metastases
- No known HIV/HBV/HCV
- No other malignancy within 3 years of study
- No prior treatment with crizotinib
- No insulin dependent diabetes
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression patterns predictive of response: Atezolizumab plus chemotherapy in patients with TMB-H/MSI-H/dMMR-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVAny: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Any line but cannot have previously had PD-1
Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)
PD-L1 inhibitor + chemotherapy
Axel Grothey, MD
Genentech, Inc.
TMB high, defined as > or = 10 mutations/megabase
- Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
- Positive biomarker results from a CLIA certified lab, either tissue or blood sample
- Tumor mutational burden-high (TMB-H) determined by CLIA opr quivalently certified assay, via tissue or blood
- No prior treatment with anti-PD1 or anti-PD-L1 agents
- ECOG PS 0-2
- No symptomatic CNS metastases
- No known HIV/HBV/HCV
- No other malignancy within 3 years of study
- No prior treatment with crizotinib
- No active autoimmune disease
myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genoic alterations or protein expression patterns predictive of response: Atezolizumab plus chemotherapy in patients with TMB-H/MSI-H/dMMR-positive tumors
VIEW TRIAL ON CLINICALTRIALS.GOVAny: Lung, Breast, Colon, Prostate, Small Cell lung, thyroid, head and neck, HNSCC, liver, pancreas, endometrial, cervical, ovarian, skin, melanoma, leukemia, lymphoma, urothelial (bladder), kidney (RCC), myeloma, gastric, small bowel,
Stage 4
Phase 2
Open to Enrollment
Any, but cannot have had prior anti-PD-1 or anti-PD-L1
Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)
PD-L1 inhibitor + chemotherapy
Axel Grothey, MD
Genentech, Inc.
MSI-h or dMMR
- Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
- Positive biomarker results from a CLIA certified lab, either tissue or blood sample
- Microsatellite instability high (MSI-h) or deficient mismatch repair dMMR
- No prior treatment with anti-PD1 or anti-PD-L1 agents
- ECOG PS 0-2
- No symptomatic CNS metastases
- No known HIV/HBV/HCV
- No other malignancy within 3 years of study
- No prior treatment with crizotinib
- No active autoimmune disease
A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
VIEW TRIAL ON CLINICALTRIALS.GOVSolid Tumors: Breast, Lung (NSCLC), Colon, Prostate, Bladder, Kidney, Esophagus, Stomach (Gastric), Liver (HCC), Cervical, Endometrial, Ovarian, Skin, Head and Neck (SCCHN), Bladder, Kidney (renal cell), Pancreatic, Rectal, Brain (GBM, glioblastoma)
Stage 4
Phase 2
Open to Enrollment
Following all effecive therapy (late line)
Pemigatinib
FGFR inhibitor
Dan Vaena, MD
Incyte Corporation
FGFR 1,2,3 mutated or FGFR 1,2,3 fusion/translocation
- Metastatic or surgically unresectable solid tumor
- Measurable disease
- Documentation of an FGFR1-3 gene mutation or translocation
- At least 1 prior line of therapy with progression
- No other therapy available likely to provide clinical benefit
- ECOG PS 0-2
- No other FGFR inhibitors within last 6 months
- No clinically significant corneal or retinal disorder
- No untreated CNS disease (except primary brain cancer)
- No additional malignancy at current time requiring active treatment
- No history of calcium or phosphate disorder or systemic mineral imbalance
- No clinically significant cardiac disease
- No active HBV/HCV
- No known HIV
An open-label, multicenter, multinational, phase 2 study exploring the efficacy and safety of neratinib therapy in patients with solid tumors with activating HER2, HER3 or EGFR mutations or with EGFR gene amplification
VIEW TRIAL ON CLINICALTRIALS.GOVBladder, Breast, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Melanoma, Ovarian, Endometrial (Uterine), Cervical, Gastric, Pancreatic, Hepatocellular (HCC), Esophageal, lymphoma, sarcoma
Stage 4
Phase 2
Open to Enrollment
Any (provided no curative therapy available)
Neratinib
pan-HER TKI
Lee Schwartzberg, MD
Puma Biotechnologies
HER2 (ERBB2) mutation or HER4 (ERBB4 mutation), or EGFR ex. 18 mutated lung cancer
- Histologically confirmed cancer for which no curative therapy exists
- Documented HER2 (ERBB2) or HER4 (ERBB4) mutation in any malignancy or EGFR ex 18 mutations in lung cancer.
- Currently CLOSED cohorts include: HER2mt lung, colorectal, and biliary
- At least one measurable or evaluable lesion
- LVEF >/=50%
- ECOG PS 0-2
- No prior treatment with ERBB2 (HER2) directed TKIs (eg lapatinib, afatinib, neratinib)
- No symptomatic or unstable brain mets (stable are allowed)
- No cumulative prior anthracycline dose >450mg/m2 doxorubicin or equivalent
- No uncontrolled cardiac disease
- No chronic diarrheal disorder
A Phase I/II, Open-Label, Dose Escalation and Cohort Expansion Study Evaluating the Safety, Pharmacokinetics (PK), Pharmacodynamics (PD), and Therapeutic Activity of OBI-888 in Patients With Locally Advanced or Metastatic Solid Tumors.
VIEW TRIAL ON CLINICALTRIALS.GOVColon, Ovarian, Gastric, Pancreatic, Endometrial, lung, prostate, breast
Stage 4
Phase 1
Open to Enrollment
Late line
OBI-888
Anti-globo-H antibody
Axel Grothey, MD
OBI Pharma
Globo-H overexpression
- Histologically or cytologically confirmed patients with advanced or metastatic solid tumors
- Measurable disease
- Must have been treated with all estrablished standard-of-care therapy or determined by the physician that such established therapy is not sufficiently efficacious, or patients have declined to receive standard of care therapy
- ECOG PS 0-1
- Must have Globo-H overexpression as measured by central lab
- No known active autoimmune or inflammatory disease
- Not receiving systemic steroids of >10mg prednisone per day or equivalent
Phase 1/1b Study of the Safety of TTX-030 as a Single Agent and in Combination With Pembrolizumab or Chemotherapy in Patients With Lymphoma or Solid Tumor Malignancies
VIEW TRIAL ON CLINICALTRIALS.GOVLung, Breast, Colon, Pancreas, Bladder, Kidney, Prostate, Melanoma, Lymphoma, Gastric, Head and Neck (SCCHN)
Stage 4
Phase 1
Open to Enrollment
Any line as long as appropriate to give study acceptable chemo in combination
TTX-030
anti CD-39
Dan Vaena, MD
Trishula Therapeutics, Inc.
Any malignancy
- Advanced solid tumor or relapsed/refractory lymphoma OR
- eligible to receive single agent pembrolizumab as standard-of-care OR
- eligible to receive single-agent docetaxel as standard of care OR
advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care
- Measurable disease
- ECOG PS 0-1
- No history of severe autoimmune disease
- Not receiving high-dose systemic steorid therapy or any other form of immunosuppressive therapy
A Phase 1a/1b study of COM701 as monotherapy and in combination with an anti-PD-1 antibody in subjects with advanced solid tumors.
VIEW TRIAL ON CLINICALTRIALS.GOVOvarian, uterine, endometrial, breast, TNBC, lung, colon, CRC, NSCLC, head and neck, SCCHN, gastric, stomach, kidney, renal, RCC, bladder, transitional cell,
Stage 4
Phase 1
Open to Enrollment
Late line
COM-701, PD(L)-1 antibody
PVRIG monoclonal antibody, PD(L)-1 antibody
Dan Vaena, MD
Compugen
- Histologically or cytologically confirmed, metastatic solid malignancy
- Has exhausted all available standard therapy or not a candidate for standard therapy
- ECOG PS 0-1
- Prior PD-1/PD-L1 allowed
- No other malignancy within 2 years prior
- No active autoimmune disease requiring systemic therapy within last 2 years
- No chronic steroids or immunosuppressants.
A Phase 1/2 first-in-human study of BMS-986258 alone and in combination with nivolumab in advanced malignant tumors
VIEW TRIAL ON CLINICALTRIALS.GOVRenal cell (kidney), CRC (colon, rectal, colorectal), lung cancer (NSCLC), Head and Neck (SCCHN), Triple Negative Breast (TNBC)
Stage 4
Phase 1
Open to Enrollment
2nd line or greater
BMS 986258
TIM-3 antibody
Dan Vaena, MD
Bristol Myers Squibb
Lung- non-small cell; Breast- Triple Negative; RCC- clear cell; CRC- any; SCCHN- any
- ECOG PS 0-1
- No active CNS disease (controlled brain mets are allowed)
- Must have one of the five malignancies below
- Clear-cell RCC
- Triple-negative Breast Cancer
- Squamous cell carcinoma of the head and neck
- Colorectal cancer
- Non-small cell lung cancer
- No other malignancies within 2 years
- No active, known, or suspected autoimmune disease (except asthma, vitiligo, T1DM, hypothyroidism, Graves disease, or psoriasis not requiring treatment)
- No severe autoimmune reactions to immunotherapy
- No need for active steroid therapy
- No significant cardiac disease
- No chronic hepatitis
- No active interstitial lung disease
- RCC specific eligibility criteria
- Previously received one or two anti-VEGFR therapies
- No more than 3 total prior systemic tx in metastatic setting
- Must have evidence of progression on or after last treatment received and within 6 months of starting study
- CRC specific eligibilty criteria
- Must have received and progressed on at least 1 standard therapy for metastatic disease
- Must have known MSI status
- NSCLC specific eligibility criteria
- Must have progressed on or been refractory to platinum doublet
- Must have known EGFR, ALK, ROS1 status.
- Those with EGFR or ALK alterations must have previously received TKI therapy
- SCCHN specific eligibility criteria
- Not amenable ot local therapy with curative intent
- Must have progressed on or been intolerant of platinum containing regimen
- TNBC specific eligibility criteria
- Must have received and progressed on or been intolerant to at least 1 standard chemotherapy with anthracycline and taxane