West Cancer Center

PROSTATE: 1st Line Chemo: Nivo+Taxotere: Checkmate 7DX

A Phase 3, Randomized, Double-Blind Study of Nivolumab or Placebo in Combination With Docetaxel, in Men With Metastatic Castration-resistant Prostate Cancer

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Malignancy

Prostate Cancer

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

1st Line Chemo

Investigational Agent

Nivolumab

Drug Class

PD-1 inhibitor

PI

Dan Vaena, MD

Sponsor

Bristol-Myers Squibb

Path

Adenocarcinoma

Key Eligibility Criteria Details

Histologic confirmation of adenocarcinoma of the prostate without small cell features
Current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue lesions on CT/MRI
ECOG PS 0-1
Ongoing androgen deprivation therapy (ADT) with a GnRH analogue or bilateral orchiectomy
Documented disease progression per PCWG3 criteria within 6 months prior to screening
Only one prior 2nd generation hormonal therapy in the metastatic setting
- Patients may have received two prior 2nd gen HT (abi + enza or apalutamide or darolutamide) if and only if the first drug had been used in the non-metastatic setting
Chemotherapy naive for metastatic CRPC
Must have progressed during or after 2nd gen hormonal therapy or have documented intolerance to 2nd gen HT
No active brain mets
No known or suspected autoimmune disease
No condition requiring systemic corticosteroids (>10 mg prednisone or equivalent)
No prior treatment with PD-1 or PD-L1 antibodies

MOLECULARLY TARGETED: ROS1 fusion: myTACTIC Arm A

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

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Malignancy

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

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Ideally 1st line, but can be later line as well

Investigational Agent

Entrectinib

Drug Class

TKI against NTRK, ROS, and ALK

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ROS1 fusion. Any cancer type except not NSCLC

Key Eligibility Criteria Details

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

MOLECULARLY TARGETED: PIK3CA Mutations: myTACTIC Arm B

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

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Malignancy

Breast, 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

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

GDC-0077

Drug Class

PI3K p110 alpha inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

PIK3CA mutation positive. Any malignancy except NOT CNS tumors

Key Eligibility Criteria Details

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)

MOLECULARLY TARGETED: ALK Rearrangement: myTACTIC Arm C

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

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Malignancy

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

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Alectinib

Drug Class

ALK and RET inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ALK rearrangement/fusion in any malignancy except not NSCLC

Key Eligibility Criteria Details

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

MOLECULARLY TARGETED: PTEN loss/LOF: myTACTIC Arm D(1)

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

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Malignancy

Any: 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

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Ipatasertib

Drug Class

AKT inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

PTEN loss or loss of function

Key Eligibility Criteria Details

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

MOLECULARLY TARGETED: AKT mutation: myTACTIC Arm D(2)

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

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Malignancy

Any: 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

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

Ipatasertib

Drug Class

AKT inhibitor

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

select AKT mutations

Key Eligibility Criteria Details

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

MOLECULARLY TARGETED: TMB high: myTACTIC Arm E(1)

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

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Malignancy

Any: 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

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line but cannot have previously had PD-1

Investigational Agent

Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)

Drug Class

PD-L1 inhibitor + chemotherapy

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

TMB high, defined as > or = 10 mutations/megabase

Key Eligibility Criteria Details

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

MOLECULARLY TARGETED: MSI-h/dMMR: myTACTIC Arm E(2)

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

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Malignancy

Any: 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

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any, but cannot have had prior anti-PD-1 or anti-PD-L1

Investigational Agent

Atezoliumab + chemotherapy (investigators choice- capecitabine, paclitaxel, or docetaxel)

Drug Class

PD-L1 inhibitor + chemotherapy

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

MSI-h or dMMR

Key Eligibility Criteria Details

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

MOLECULARLY TARGETED: HER2/ERBB2 amplification or mutation: myTACTIC Arms F/G/H/I

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response: Arm F: Trastuzumab emtansine plus atezolizumab Arm G: PH FDC SC Arm H: PH FDC SC plus chemotherapy Arm I: trastuzumab emtansine plus tucatinib, in patients with ERBB2 gene amplification- or mutation-positive tumors.

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Malignancy

Lung, 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

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any, but cannot have had prior

Investigational Agent

TDM-1 with atezolizumab, or PH FDC SC with or without chemotherapy, or TDM-1 with tucatinib

Drug Class

Anti-HER2 agents

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ERBB2 amplification or specific mutation

Key Eligibility Criteria Details

Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
Positive biomarker results from a CLIA certified lab, either tissue or blood sample
No breast cancer (breast cancer is excluded)
Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
Any of the following ERBB2 mutations:
- 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896CG
TMB must be <10 mutations/megabase
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

MOLECULARLY TARGETED: HER2/ERBB2 amp or mut; TMB-h: myTACTIC Arm J

myTACTIC: An open-label Phase II study evaluating targeted therapies in patients who have advanced solid tumors with genomic alterations or protein expression patterns predictive of response: Arm J: Trastuzumab emtansine plus atezolizumab in patients with ERBB2 amplification or mutation plus TMB-H/MSI-H/dMMR-positive tumors

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Malignancy

Lung, 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

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any line

Investigational Agent

TD-M1 + atezolizumab

Drug Class

anti-HER2 agent and anti-PD-L1 agent

PI

Axel Grothey, MD

Sponsor

Genentech, Inc.

Path

ERBB amplificaiton or mutation AND TMB-h or MSI-h or dMMR

Key Eligibility Criteria Details

Histologically or cytologically confirmed advanced unresectable or metastatic solid malignancy
Positive biomarker results from a CLIA certified lab, either tissue or blood sample
No breast cancer (breast cancer is excluded)
Either ERBB2 (HER2) amplification defined as a copy number of 6 or higher via FISH, CISH or DNA NGS assay OR
Any of the following ERBB2 mutations:
- 222C; R226S; E265K; D277H; G292R; G309A/E; S310F/Y; C311R/S; E321G; C334S; S418T; A440T; P551L; R552S; S653C; V659E; G660D; R678Q; T733I; L755P/S_T759del; I767M; L768S; D769H/N/Y; Y772_A775dup; A775_G776ins(SVMA/VVMA/YAMA/YVMA/YVMD); G776delins(VC/VV/LC); V777L; G778_P780dup; V779A/L; T798M; L841V; V842I; N857S; T862A; L869R; H878Y; R896CG
Must ALSO have one of the following alterations
- TMB > or =10 mutations/megabase
- MSI-h
- dMMR (negative IHC for MLH1, MSH2, MSH6, or PMS2_
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

MOLECULARLY TARGETED: FGFR-mutant or fusions: FGFR inhibitor: FIGHT-207

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)

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Malignancy

Solid 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

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Following all effecive therapy (late line)

Investigational Agent

Pemigatinib

Drug Class

FGFR inhibitor

PI

Dan Vaena, MD

Sponsor

Incyte Corporation

Path

FGFR 1,2,3 mutated or FGFR 1,2,3 fusion/translocation

Key Eligibility Criteria Details

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

MOLECULARLY TARGETED: Metastatic; Solid Tumors: HER2mt or ERBB4mt: SUMMIT

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

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Malignancy

Bladder, Breast, Brain (GBM), Head and Neck, Prostate, Kidney (Renal Cell), Melanoma, Ovarian, Endometrial (Uterine), Cervical, Gastric, Pancreatic, Hepatocellular (HCC), Esophageal, lymphoma, sarcoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Any (provided no curative therapy available)

Investigational Agent

Neratinib

Drug Class

pan-HER TKI

PI

Lee Schwartzberg, MD

Sponsor

Puma Biotechnologies

Path

HER2 (ERBB2) mutation or HER4 (ERBB4 mutation), or EGFR ex. 18 mutated lung cancer

Key Eligibility Criteria Details

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

ADVANCED SOLID TUMORS: PHASE 1: ENDOMETRIAL, OVARIAN, Or PVRL2: CPG-03-101

A Phase 1/2 Study Evaluating the Safety, Tolerability and Preliminary Antitumor Activity of COM701 in Combination With BMS-986207 (Anti-TIGIT Antibody) and Nivolumab in Subjects With Advanced Solid Tumors.

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Malignancy

Endometrial, Ovarian, Breast, Lung, Colon, Prostate, Gastric, Esophageal, Cervical, Melanoma, Skin, Pancreas, Pancreatic, Sarcoma, Head and Neck (HNPCC), NSCLC, SCLC, Kidney, Bladder, RCC, Prostate

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line (post standard therapy)

Investigational Agent

COM-701, BMS-986207, nivolumab

Drug Class

PVRIG antagonist, anti-TIGIT Ab, PD-1 antibody

PI

Dan Vaena, MD

Sponsor

Compugen, Ltd

Path

PVRL2 high (only for basket cohort)

Key Eligibility Criteria Details

Histologically or cytologically confirmed, locally advanced or metastatic solid malignancy and has exhausted all available standard therapy or not a candidate for standard therapy
ECOG PS 0-1
Prior therapy with immune therapy are eligible (except in ovarian cohort)
In Expansion cohorts patients must either have
- Advanced epithelial cancer of the ovary, fallopian tube, or peritoneum
- Advanced MSS endometrial cancer
- A different malignancy that has high expression of PVRL2
No active autoimmune disease
No interstitial lung disease
No active CNS metastases
In ovaran cohort, no prior immunotherapy
No prior therapy with PVRIG inhibitor or anti-TIGIT antibody

ADVANCED SOLID TUMORS: PHASE 1: OBI-888

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.

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Malignancy

Colon, Ovarian, Gastric, Pancreatic, Endometrial, lung, prostate, breast

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Late line

Investigational Agent

OBI-888

Drug Class

Anti-globo-H antibody

PI

Axel Grothey, MD

Sponsor

OBI Pharma

Path

Globo-H overexpression

Key Eligibility Criteria Details

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

ADVANCED TUMORS: PHASE 1: ADENOSINE PATHWAY: TTX-030-001

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

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Malignancy

Lung, Breast, Colon, Pancreas, Bladder, Kidney, Prostate, Melanoma, Lymphoma, Gastric, Head and Neck (SCCHN)

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

Any line as long as appropriate to give study acceptable chemo in combination

Investigational Agent

TTX-030

Drug Class

anti CD-39

PI

Dan Vaena, MD

Sponsor

Trishula Therapeutics, Inc.

Path

Any malignancy

Key Eligibility Criteria Details

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

ADVANCED SOLID TUMORS: PHASE 1: ADENOSINE PATHWAY: TTX-030-002

Phase 1/1b Study to Evaluate the Safety and Activity of TTX-030 (Anti-CD39) in Combination With Budigalimab and/or Chemotherapy in Subjects With Advanced Solid Tumors

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Malignancy

Prostate, Kidney, Head and Neck, Colon Rectum, Gastric, Esophagus

Stage

Stage 4

Phase

Phase 1

Status

Open to Enrollment

Line Of Therapy

late line

Investigational Agent

TTX-030, budigalimab

Drug Class

Anti CD-39, anti-PD1

PI

Dan Vaena, MD

Sponsor

Tizona Therapeutics

Path

Any

Key Eligibility Criteria Details

Advanced Solid Malignancy
Fresh and/or archival tumor tissue
Evidence of measurable disease (except for prostate)
Life expectancy >12 weeks
ECOG PS 0-1
No therapeutic anticoagulation
no history of autoimmune disease
No uncontrolled intercurrent illness
No HTN >150/90 despite optimal management
No active CNS mets
No other malignancies within 3 years
No autoimmune toxicity >Grade 3 from prior immunotherapy

How Dr. Matthew Ballo helped transform West into a holistic cancer center

Clinical Trials