Clinical Trials for Colon Cancer

Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

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.

HealthScout AI summary: This trial enrolls treatment-naïve adults with metastatic colorectal adenocarcinoma harboring a KRAS p.G12C mutation and randomizes them to receive either sotorasib (a KRAS G12C inhibitor), panitumumab, and FOLFIRI, or FOLFIRI with or without bevacizumab-awwb. Excludes include prior KRAS G12C inhibitor use, untreated CNS metastases, and significant pulmonary disease.

ClinicalTrials.gov ID: NCT06252649

An Open-label, Phase Ib Study to Assess the Safety and Clinical Activity of CYAD-101 Administered Concurrently With FOLFOX Chemotherapy, Followed by Pembrolizumab Treatment, in Patients With Metastatic Colorectal Cancer

Active drug

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

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults with unresectable, metastatic, microsatellite stable (non-MSI-H/pMMR) colorectal cancer refractory to standard chemotherapy, and tests the combination of CYAD-101 (an allogeneic NKG2D-based CAR T-cell therapy targeting stress-induced tumor ligands), concurrent FOLFOX chemotherapy, and sequential pembrolizumab. Key exclusions include prior checkpoint inhibitor therapy and significant pulmonary or recent treatment-related toxicities.

ClinicalTrials.gov ID: NCT04991948

A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01)

Active drug

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

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults with refractory or metastatic colorectal cancer who have progressed after standard therapies, including immunotherapy for MSI-high tumors. Patients receive M9140, an antibody-drug conjugate targeting CEACAM5 and delivering a topoisomerase 1 inhibitor (exatecan), either alone or in combination with metastatic colorectal cancer standard regimens (bevacizumab, capecitabine, or 5-FU/folinic acid).

ClinicalTrials.gov ID: NCT05464030

A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided Colorectal Cancer

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.

HealthScout AI summary: This trial enrolls adults with unresectable or metastatic, left-sided colorectal adenocarcinoma that is KRAS, NRAS, and BRAF wild-type, and compares amivantamab (a bispecific EGFR/MET antibody) plus standard chemotherapy (mFOLFOX6 or FOLFIRI) to cetuximab plus the same chemotherapy as first-line treatment. Key exclusions include prior EGFR or MET inhibitor use, dMMR/MSI-H, or HER2-positive tumors.

ClinicalTrials.gov ID: NCT06662786

A Phase II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic Colorectal Cancer or Hepatocellular Carcinoma

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.

HealthScout AI summary: This trial enrolls adults with advanced or metastatic colorectal cancer (after 2-3 prior therapies) or hepatocellular carcinoma (after 1-2 prior therapies), who have good performance status and organ function. All patients receive enfortumab vedotin, an antibody-drug conjugate targeting Nectin-4 that delivers MMAE to tumor cells, administered intravenously every 28 days.

ClinicalTrials.gov ID: NCT06553885

A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)

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.

HealthScout AI summary: This trial enrolls adults with newly diagnosed, limited (≤4 sites, non-liver-only, non-peritoneal) metastatic colorectal adenocarcinoma who have not progressed after first-line systemic therapy, randomizing them to standard chemotherapy with or without total ablative therapy (SABR, surgical resection, and/or microwave ablation) to all metastatic sites. Patients with MSI-H or BRAF V600E-mutated tumors are excluded.

ClinicalTrials.gov ID: NCT05673148

An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Active drug

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

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls patients with locally advanced or metastatic solid tumors—including specific cohorts for Ewing sarcoma, colorectal adenocarcinoma, malignant pleural mesothelioma, gastric adenocarcinoma, and SDH-deficient/GIST—who receive INBRX-109, a tetravalent agonistic DR5 antibody that induces tumor cell apoptosis, as monotherapy or in combination with standard chemotherapy regimens. Eligible patients must have measurable disease, good organ function and performance status, and no prior DR5 agonist exposure.

ClinicalTrials.gov ID: NCT03715933

A Phase II Pilot Study of yttriuM-90 in Combination With capEcitabine and aTezolizumab for oligomEtastatic cOlorectal Cancer With unResectable lIver MeTastasEs (METEORITE)

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.

HealthScout AI summary: This trial enrolls adults with histologically confirmed colorectal adenocarcinoma and unresectable, liver-dominant metastatic disease who have progressed after at least two prior lines of systemic therapy, excluding those with prior Y-90/liver radiotherapy, extrahepatic metastases, dMMR/MSI-H/TMB-H tumors, or previous checkpoint inhibitor exposure. Patients receive intra-arterial yttrium-90 radioembolization, oral capecitabine, and intravenous atezolizumab (an anti–PD-L1 monoclonal antibody) to assess efficacy and safety of this multimodal approach.

ClinicalTrials.gov ID: NCT06555133

An Open-label Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors

Active drug

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

High burden on patient

The trial has a high burden on patients. An example would be a phase 1 trial with extra tumor biopsies and frequent pharmacokinetic blood draws.

Started >3 years ago

The trial was activated more than 3 years ago. This is not always bad but can indicate that the trial has less current treatments, or has had trouble getting enough patients to enroll due to other issues.

HealthScout AI summary: This trial enrolls adults with unresectable hepatocellular carcinoma, metastatic colorectal cancer, or advanced solid tumors (including endometrial carcinoma) who have progressed after standard therapies, testing the investigational oral agent E7386—a CBP/β-catenin interaction inhibitor targeting the Wnt/β-catenin pathway—in combination with lenvatinib or standard chemotherapy. The current dose optimization phase randomizes endometrial carcinoma patients to E7386 plus lenvatinib, lenvatinib monotherapy, or physician’s choice.

ClinicalTrials.gov ID: NCT04008797

An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ Metastatic Colorectal Cancer

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.

HealthScout AI summary: This trial enrolls adults with previously untreated, HER2-positive, RAS wild-type metastatic colorectal cancer to compare standard first-line mFOLFOX6-based regimens versus mFOLFOX6 combined with trastuzumab and tucatinib, a selective oral HER2 tyrosine kinase inhibitor. Eligible patients may have stable, treated brain metastases.

ClinicalTrials.gov ID: NCT05253651