Clinical Trials for Colon Cancer

A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: This trial involves adult patients with advanced solid tumors who have limited treatment options, evaluating the efficacy and safety of IBI363, a PD-1/IL-2α-bias bispecific antibody fusion protein targeting the PD-1/PD-L1 pathway and activating the IL-2 pathway to enhance tumor-specific T cell activity.

ClinicalTrials.gov ID: NCT06281678

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: This trial enrolls adults with metastatic or unresectable solid tumors (excluding NSCLC) harboring activating HER2 mutations, who have progressed on standard therapy or have no satisfactory alternatives. Patients receive BAY2927088, an oral reversible tyrosine kinase inhibitor targeting mutant HER2 and EGFR.

ClinicalTrials.gov ID: NCT06760819

Phase II Open-Label Multi-Cohort Study Evaluating CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Patients With Advanced Chemorefractory Colorectal, Pancreatic, or Other Solid Cancers

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Enrolling adults with advanced or metastatic colorectal, pancreatic, biliary, gastroesophageal, urothelial, ovarian, or non-small cell lung adenocarcinomas refractory to standard chemotherapy, this study combines the mitochondrial metabolism inhibitor devimistat (CPI-613) with hydroxychloroquine and either 5-FU or gemcitabine depending on tumor type. Eligible patients must have measurable disease and good performance status (ECOG 0-1, some 2 with approval).

ClinicalTrials.gov ID: NCT05733000

A Phase 2, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants With Colorectal Cancer Who Have Cancer Cachexia

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: This trial enrolls adults with documented colorectal cancer and cancer cachexia per Fearon criteria, excluding those with reversible causes of decreased food intake or on tube/parenteral nutrition. Participants are randomized to subcutaneous NGM120, a GFRAL antagonist monoclonal antibody that inhibits GDF15 signaling, or placebo.

ClinicalTrials.gov ID: NCT07033026

Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorectal Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with metastatic colorectal adenocarcinoma, grouped into three cohorts: dMMR/MSI-H refractory to prior PD-1/PD-L1 ± CTLA-4, pMMR/MSS with active non-bulky liver metastases, or pMMR/MSS without liver metastases (cohorts 2–3 post–fluoropyrimidine/oxaliplatin/irinotecan), receive ivonescimab monotherapy. Ivonescimab is a bispecific antibody targeting PD-1 and VEGF to relieve immune suppression and inhibit angiogenesis; primary endpoint is ORR by iRECIST.

ClinicalTrials.gov ID: NCT06959550

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with unresectable locally advanced or metastatic colorectal adenocarcinoma harboring a KRAS G12C mutation, treatment-naive in the first-line metastatic setting, are randomized to mFOLFOX6 ± bevacizumab versus mFOLFOX6 plus cetuximab and MK-1084, a selective covalent KRAS G12C inhibitor that locks KRAS in its inactive GDP-bound state. Key exclusions include active CNS metastases, DPD deficiency, significant uncontrolled cardiovascular disease, and conditions precluding bevacizumab; controlled HIV/HBV and cured/controlled HCV are allowed.

ClinicalTrials.gov ID: NCT06997497

AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Enrolls adults with previously untreated metastatic (stage IV) colorectal adenocarcinoma, ECOG 0–1, RECIST-measurable disease, adequate organ function, excluding MSI-high/dMMR or BRAF V600E tumors and patients with active symptomatic CNS metastases, significant bleeding/cardiovascular risk, or active autoimmune disease requiring systemic therapy. Compares PF-08634404 (SSGJ-707), a bispecific antibody targeting PD-1 and VEGF, plus standard first-line IV chemotherapy versus bevacizumab (anti-VEGF) plus the same chemotherapy, treating until progression or unacceptable toxicity.

ClinicalTrials.gov ID: NCT07222800

ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with previously untreated, unresectable or metastatic colorectal adenocarcinoma with measurable disease that is MSS/pMMR and without known BRAF V600E are randomized (blinded) to first-line doublet chemotherapy (FOLFOX/FOLFIRI ± CAPOX) plus pumitamig (BNT327/PM8002), a bispecific anti–PD-L1/anti–VEGF-A antibody, versus the same chemotherapy plus bevacizumab. Primary efficacy focuses on objective response in the dose-selection portion and progression-free survival by blinded central review in the confirmatory portion.

ClinicalTrials.gov ID: NCT07221357

A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo® in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care for First-line Treatment of Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Enrolling adults with previously untreated, locally advanced unresectable or metastatic colorectal cancer that is non–MSI-H/dMMR and centrally confirmed PD-L1–positive (ECOG 0–1; excludes BRAF V600E and prior checkpoint inhibitor use). Patients are randomized to mFOLFOX6 plus bevacizumab alone or the same backbone plus nivolumab with oral ONO-4578 (two dose levels), a prostaglandin E2 EP4 (PTGER4) receptor antagonist intended to reduce PGE2-driven tumor immunosuppression and enhance PD-1 blockade.

ClinicalTrials.gov ID: NCT06948448

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer

Investigational drug late phase

The trial is testing an investigational drug and is at least phase 2, suggesting that the drug has shown promise in phase 1 studies and might have a high chance of working well compared to other investigational drugs.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

Moderate burden on patient

The trial has a moderate burden on patients. An example would be a trial testing an IV drug, with scans every 8 weeks which would be more frequent than standard of care.

TrialFetch AI summary: Adults with previously untreated metastatic colorectal cancer (ECOG 0–1) with at least one measurable noncerebral lesion are randomized, excluding MSI-H/dMMR tumors and known BRAF V600E mutation. Patients receive ivonescimab (AK112; bispecific anti–PD-1/anti-VEGF antibody) plus mFOLFOX6 every 2 weeks for up to 8 cycles followed by ivonescimab + 5-FU/leucovorin maintenance, versus bevacizumab plus mFOLFOX6 followed by bevacizumab + 5-FU/leucovorin maintenance (up to 2 years).

ClinicalTrials.gov ID: NCT07228832