Clinical Trials for Colon Cancer

A Randomized Trial of Microbiotic Product (NBT-NM108) to Promote Microbiome Health and Improve Chemotherapy Delivery

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.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

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 metastatic colon cancer who are candidates for second-line or later irinotecan-based chemotherapy, randomizing them to receive standard chemotherapy with or without NBT-NM108, an oral botanical agent designed to modulate the gut microbiome and boost short-chain fatty acid production. Patients must have good performance status and no significant baseline diarrhea; the study aims to assess whether NBT-NM108 reduces diarrhea and enables improved chemotherapy delivery.

ClinicalTrials.gov ID: NCT05296681

Phase II Study Evaluating the Efficacy of PDS01ADC in Combination With Hepatic Artery Infusion Pump (HAIP) and Systemic Therapy for Subjects With Metastatic Colorectal Cancer, Intrahepatic Cholangiocarcinoma, or Metastatic Adrenocortical Carcinoma

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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.

HealthScout AI summary: This trial enrolls adults with liver-only or liver-dominant metastatic colorectal cancer, intrahepatic cholangiocarcinoma, or adrenocortical carcinoma who have progressed on prior chemotherapy, and treats them with hepatic artery infusion pump (HAIP) floxuridine-based chemotherapy plus standard systemic therapy and PDS01ADC, an investigational IL-12–based immunocytokine targeting necrotic tumor regions to enhance local immune activation. Cohorts are separated by tumor type.

ClinicalTrials.gov ID: NCT05286814

A Single Arm Phase 4 Trial to Evaluate the Safety and Efficacy of Oral Fruquintinib in the Treatment of Refractory Metastatic Colorectal Cancer in Patients From Minority Populations Underrepresented in Prior Fruquintinib Studies

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 adult patients with refractory metastatic colorectal adenocarcinoma who self-identify as Black/African American or Hispanic/Latino and have ECOG 0–1, treating them with oral fruquintinib, a VEGFR 1/2/3 inhibitor, to assess safety—particularly incidence of hypertension—and efficacy in this underrepresented population.

ClinicalTrials.gov ID: NCT06562543

Randomized Trial of Regorafenib in Combination With Pembrolizumab or Pembrolizumab Monotherapy With an Efficacy Lead-in of Regorafenib and Pembrolizumab for Patients With MSI-H 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 advanced MSI-H or mismatch repair-deficient metastatic colorectal cancer (ECOG 0-1, limited prior chemotherapy) and tests pembrolizumab (anti-PD-1) alone versus pembrolizumab plus regorafenib, a multi-kinase inhibitor with antiangiogenic and immunomodulatory effects. Key exclusions include prior checkpoint/CTLA-4 therapy and active brain metastases.

ClinicalTrials.gov ID: NCT06006923

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 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