Clinical Trials for Colon Cancer

Phase 2 Study of SR-8541A in Combination With Botensilimab and Balstilimab in Subjects With Refractory Metastatic Microsatellite Stable Colorectal Cancer (MSS-CRC)

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.

TrialFetch AI summary: This trial enrolls adults with unresectable, metastatic microsatellite stable colorectal cancer (MSS-CRC) who have progressed after at least one prior chemotherapy regimen, including those with or without active liver metastases. Patients will receive the novel oral ENPP1 inhibitor SR-8541A (which enhances STING pathway activity) in combination with the CTLA-4 inhibitor botensilimab and the PD-1 inhibitor balstilimab.

ClinicalTrials.gov ID: NCT06589440

Ablative Dose Single Fraction MRguided Colorectal Liver Metastasis SBRT

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 1-3 measurable colorectal cancer liver metastases (with specific size/location criteria), ECOG 0-2, and no cirrhosis, including those with prior therapies or extrahepatic disease, to receive a single 40 Gy fraction of MR-guided, adaptive SBRT for local control.

ClinicalTrials.gov ID: NCT06130280

Pilot Study Evaluating Microbiome Modulation Therapy (MBMT) With Ciprofloxacin, Metronidazole, and Aspirin in Addition to Standard of Care Chemotherapy in Patients Undergoing First-Line Therapy for 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.

TrialFetch AI summary: Adults with newly diagnosed metastatic (stage IV) colorectal cancer eligible for first-line 5-fluorouracil-based doublet chemotherapy are randomized to standard chemotherapy with or without an investigational microbiome modulation therapy (MBMT) consisting of oral ciprofloxacin, metronidazole, and low-dose aspirin, aiming to assess whether altering the gut microbiome improves treatment response. Patients with recent antibiotic use, high bleeding risk, or MBMT drug allergies are excluded.

ClinicalTrials.gov ID: NCT06728072

A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy

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 recurrent, unresectable, or metastatic KRAS/NRAS/BRAF wild-type colorectal cancer who have progressed after prior fluoropyrimidine- and oxaliplatin-based chemotherapy, randomizing them to receive either amivantamab (a bispecific EGFR/MET antibody) plus FOLFIRI or standard of care FOLFIRI with either cetuximab or bevacizumab. Prior irinotecan, EGFR, MET, or HER2-targeted therapies are exclusionary.

ClinicalTrials.gov ID: NCT06750094

Randomized Phase II Trial of 5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With 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.

TrialFetch AI summary: Adults with metastatic colorectal cancer who have failed at least two prior lines of therapy and meet standard eligibility criteria are randomized to receive either 5-fluorouracil/leucovorin with regorafenib (an oral multikinase inhibitor targeting angiogenic, stromal, and oncogenic pathways) or trifluridine-tipiracil plus bevacizumab.

ClinicalTrials.gov ID: NCT06887218

A Phase 1/2 Study of Tegavivint (NSC#826393) in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid 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.

TrialFetch AI summary: This trial enrolls children, adolescents, and young adults with recurrent or refractory solid tumors (including lymphomas and desmoid tumors), treating them with intravenous tegavivint, a small molecule inhibitor targeting TBL1 to disrupt Wnt/beta-catenin signaling. Expansion cohorts focus on specific tumor types and Wnt pathway–driven malignancies.

ClinicalTrials.gov ID: NCT04851119

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic 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.

TrialFetch AI summary: This trial enrolls adults with locally advanced or metastatic solid tumors—especially those with Wnt pathway activating mutations such as APC or CTNNB1—including select colorectal, liver, desmoid, and prostate cancers, testing the oral β-catenin:TCF4 inhibitor FOG-001 as monotherapy or in combination with standard regimens (e.g., mFOLFOX-6 plus bevacizumab, nivolumab, or trifluridine/tipiracil plus bevacizumab). Eligible patients must have ECOG 0-1 and no significant bone, CNS, cardiac disease, or active IBD.

ClinicalTrials.gov ID: NCT05919264

A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

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.

TrialFetch AI summary: Adults with previously treated metastatic colorectal adenocarcinoma whose tumors harbor specific biomarkers are assigned to various arms testing targeted agents—including the PI3Kα inhibitor inavolisib, TIGIT inhibitor tiragolumab (with anti–PD-L1 and bevacizumab), CDK7 inhibitor SY-5609, and KRAS G12C inhibitor divarasib (with chemotherapy or EGFR/VEGF antibodies)—according to their molecular profile.

ClinicalTrials.gov ID: NCT04929223

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.

TrialFetch 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

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.

TrialFetch 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