West Cancer Center

COLORECTAL: METASTATIC: 1st LINE: KRAS mutant: CRDF-004

A Phase 2, Randomized, Open-label Study of Onvansertib in Combination With FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients With a KRAS or NRAS Mutation

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Malignancy

Colorectal, colon, rectum, rectal

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

Onvansertib

Drug Class

Polo-like kinase 1 inhibitor

PI

Brad Somer, MD

Sponsor

Cardiff Oncology

Path

Adenocarcinoma

Key Eligibility Criteria Details

Metastatic CRC
Documented KRAS or NRAS mutation
No prior systemic therapy in metastatic setting
ECOG PS 0-1
No BRAF mutation, no MSI-h
No prior treatment with VEG-F inhibitor
No DPD dficiency
No untreated or symptomatic CNS mets

COLON: METASTATIC: BRAFmt: MSI-h: 1st Line: SEAMARK

A PHASE 2, RANDOMIZED, OPEN-LABEL STUDY OF ENCORAFENIB AND CETUXIMAB PLUS PEMBROLIZUMAB VERSUS PEMBROLIZUMAB ALONE IN PARTICIPANTS WITH PREVIOUSLY UNTREATED BRAF V600E-MUTANT, MSI H/DMMR METASTATIC COLORECTAL CANCER

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Malignancy

Colon cancer, rectal cancer, colorectal cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

encorafenib, cetuximab, pembrolizumab

Drug Class

BRAF inhibitor, EGFR mAb, PD-1 inhibitor

PI

Brad Somer, MD

Sponsor

Pfizer

Path

BRAF V600 mutant, MSI-h, dMMR

Key Eligibility Criteria Details

Locally confirmed microsatellite instability-high/ deficient mismatch repair (MSI-H/dMMR) stage IV colorectal carcinoma
Locally confirmed BRAF V600E mutation in tumor tissue or blood
ECOG PS 0 or 1
Have not received prior systemic regimens for metastatic disease.
Measurable disease
RAS wt
No known active central nervous system metastases and/or carcinomatous meningitis; leptomeningeal disease
No immunodeficiency or active autoimmune disease requiring systemic treatment in the past 2 years
No presence of acute or chronic pancreatitis
No previous treatment with any selective BRAF inhibitor (eg, encorafenib, dabrafenib, vemurafenib, XL281/BMS-908662) or any epidermal growth factor receptor (EGFR) inhibitor (eg, cetuximab, panitumumab).
No previous treatment with an immune checkpoint inhibitor (eg, anti-programmed cell death [PD-1], anti-PD-L1 or anti-PD-L2 agent); or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).

COLORECTAL: METASTATIC: 3rd Line: cMET+: M24-064

AndroMETa-CRC-064 Abbvie M24-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with c-Met Over-Expressed Refractory Metastatic Colorectal Cancer

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Malignancy

Colorectal, colon, rectum, rectal

Stage

Stage 4

Phase

Phase 3

Status

Open to Enrollment

Line Of Therapy

3rd or later

Investigational Agent

ABBV-400

Drug Class

Anti-cMET ADC

PI

Axel Grothey, MD

Sponsor

Abbvie

Path

Adenocarcinoma

Key Eligibility Criteria Details

Histologically or cytologically confirmed unresectable metastatic adenocarcinoma of the colon or recturm
Has already received the following regimens for advanced colorectal cancer and has demonstrated PD or intolerance to their last regimen
- Must have included a fluoropyrimidine, irinotecan, oxaliplatin, and an anti-VEGF monoclonal antibody, as well as an anti-EGFR antibody if indicated
- Patients who received adjuvant therapy and had recurrence within 12 months can count the therapy as one regimen of therapy for advanced disease
- No prior lonsurf
- Patients with MSI-h/dMMR or BRAF mt should have received appropriate therapy
Measurable disease
ECOG PS 0-1
EF >50%
No untreated CNS disease
No bevacizumab bleeding risks

PAN-TUMOR: METASTATIC: >/=2nd Line: DS7300-203: IDEATE-PANTUMOR02

A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

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Malignancy

Endometrial Cancer, Head and Neck Squamous cell carcinoma (HNSCC), Pancreatic cancer (PDAC), Colon Rectal Colorectal cancer (CRC), Hepatocellular carcinoma (HCC), Esophageal adenocarcinoma, gastroesophageal junction (GE junction), gastric, urothelial carcinoma (UC) bladder, ovarian cancer, cervical cancer, biliary tract cancer, HER2 low breast cancer, HER2 negative breast cancer, melanoma

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

2nd line or later

Investigational Agent

I-DXd

Drug Class

B7-H3 antibody drug conjugate

PI

Axel Grothey, MD

Sponsor

Daiichi Sankyo

Path

See under \\\"malignancy\\\"

Key Eligibility Criteria Details

Measurable disease
Progression on or afer the previous standard-of-care regimen in the advanced/metastatic setting
ECOG PS 0-1
No clinically active CNS mets
If Endometrial carcinoma:
- Pathologically or cytologically documented EC of any histological carcinoma subtype or endometrial carcinoma sarcoma, irrespective of MSI or MMR status
- Relapse or progression after a platinum containing treatment and ICI containing regimen as well as targeted therapies when appropriate
If Head and Neck Cancer:
- Documented unresectable or metastatic squamous cell carcinoma of the oral cavity oropharynx, hypopharynx, or larynx, excluding nasopharynx, nasal cavity and paranasal sinuses
- Disease progression after platinum-based and ICI tx, wiht targeted therapy where appropriate.
- Maximum of 2 prior lines of therapy
If pancreatic cancer
- Unresectable or metastatic pancreatic adenocarcinoma that has relapsed or progressed after 1 prior line of gemcitabine-based systemic therapy in the metastatic setting or after 2 lines of therapy if treated with targeted therapy if appropriate
If colorectal cancer
- Unresectable or metastatic CRC with known microsatellite status
- Relapse or progression after 1 prior line of tx including FOLFOX +/- bev or EFGR mAb tx, or relapse or progression after 2 lines of therapy if received targeted therapy.
- No prior irinotecan
If hepatocellular carcinoma
- Documented unresectable or metastatic HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible)
- Relapse or progression after 1 prior line of ICI tx (combo or mono) in metastatic setting.
- Maximum of 2 prior lines
- BCLC Stage B or C
- Child-Pugh Class A
- ALBI Grade 1 within 7 days
If esophageal, gastric, or GE junction cancer
- Documented unresectable or metastatic esophageal adenoCA/GE junction/Gastric carcinoma that has relapsed or progressed after 1 prior line of tx. If PD-L1+ or MSI-H should have received ICI treatment.
- Must have been treated with HER2 targeted tx if HER2 positive
If urothelial carcinoma
- Documented unresectable or metastatic UC of the bladder, renal pelvis, ureter, or urethra. Participants with histological variants are allowed if urothelial histology is predominant. Small cell/neuroendocrine tumors are not allowed even if mixed histology
- Relapse or progression after at least 1 prior line of ICI-containing tx and 1 prior line or chemo, with maximum of 3 prior lines
  - At least 1 line must include enfortumab vedotin
  - Perioperative systemic therapy will be counted as 1 line
  - If targeted therapy is appropriate should have been txed with targeted therapy
If cervical cancer
- Unresectable or metastatic cervical cancer previously treated with at least 1 line of systemic therapy in the locally advanced or metastatic setting
- Should have received PD-1/PD-L1 tx and tisotumab vedotin
If ovarian cancer
- High-grade serous ovarian cancer, high-grade endometrioid ovarian cancer, primary peritoneal cancer, or fallopian tube cancer previously treated with at least 1 line of platinum based tx + bevacizumab
- No longer eligible for platinum-based tx or has progressed less than 180 days after the last dose of platinum therapy
If biliary tract cancer
- Unresectable or metastatic biliary tract cancer (intra- or extrahepatic cholangiocarcinoma or gallbladder carcinoma). Ampullary cancer, small cell cancer, lymphoma, sarcoma, neuroendocrine cancer, mixed tumor histology, and/or mucinous cystic neoplasms are NOT allowed.
- Relapse or progression after at least 1 prior line of systemic therapy. If appropriate, should have received a targeted therapy
If HER-2 low breast cancer
- Unresectable or metastatic breast cancer with low HER2 expression defined as IHC2+/ISH- or IHC 1+ (ISH- or untested) accordoing to ASCO-CAP 2018 HER2 testing guidelines, regardless of hormonal status
- Progression on or after tx with T-DXd
- Relapse or progression after at least 2 and less than 3 lines of systmic therapy. Endocrine therapy doesn't count as line of tx.
If HER-2 negative breast cancer
- Unresectable or metastatic breast cancer negative for HER2 expression, defined as IHC 0 (ISH negative or untested) according to ASCO-CAP 2018 HER2 testing guidelines
- Relapse or progression after at least 2 and less than 3 prior systmic therapies. Endocrine tx doesn't count as line of therapy.
If melanoma
- Confirmed cutaneous (acral or non-acral) melanoma
- Disease progression while on or after having received treatment with at least 1 prior line of ICI based therapy. If BRAF mt, must have also progressed after targeted therapy