Clinical Trials for Colon Cancer

A Phase 1 Study of ZEN003694 (ZEN-3694) in Combination With Cetuximab and Encorafenib in Patients With Refractory BRAF V600E 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.

TrialFetch AI summary: Adults with refractory or relapsed BRAF V600E–mutant metastatic colorectal cancer who have progressed after systemic therapy and previously tolerated cetuximab plus encorafenib receive those agents with investigational ZEN-3694, a BET bromodomain inhibitor. The study evaluates dosing and safety of the three-drug combination.

ClinicalTrials.gov ID: NCT06102902

A Phase Ib Study of Botensilimab Plus Balstilimab and Fasting-Mimicking Diet (FMD) Plus Vitamin C in Patients with KRAS-Mutant 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.

TrialFetch AI summary: Adults with measurable, microsatellite-stable, KRAS-mutant metastatic colorectal cancer who have progressed on, cannot tolerate, or cannot receive fluoropyrimidine, oxaliplatin, and irinotecan receive botensilimab (an Fc-engineered anti-CTLA-4 antibody) plus balstilimab (an anti-PD-1 antibody), high-dose IV vitamin C, and a fasting-mimicking diet. Prior anti-PD-1 or anti-CTLA-4 therapy and current diabetes are exclusions.

ClinicalTrials.gov ID: NCT06336902

Phase I Clinical Trial of CA-4948 (Emavusertib) in Combination With FOLFOX Plus Bevacizumab as Frontline 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.

TrialFetch AI summary: Adults with measurable, unresectable or metastatic colorectal adenocarcinoma, ECOG 0–2, and no prior chemotherapy or antiangiogenic therapy may enroll; MSI-H/dMMR disease is excluded. Treatment adds oral emavusertib, an investigational IRAK4/FLT3 inhibitor, to first-line FOLFOX plus bevacizumab, with bevacizumab starting in cycle 1 or 2.

ClinicalTrials.gov ID: NCT06696768

Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)

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.

TrialFetch AI summary: Adults with previously treated, measurable metastatic colorectal cancer receive retifanlimab (anti–PD-1), a CEA/MUC1/brachyury-targeted TriAdeno vaccine, and the IL-15 agonist N-803, with or without SX-682, a CXCR1/2 inhibitor intended to limit immunosuppressive myeloid-cell trafficking. Patients with MSI-H/dMMR disease must have received prior checkpoint inhibitor therapy.

ClinicalTrials.gov ID: NCT06149481

Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Metastatic Colorectal Cancer

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

TrialFetch AI summary: Adults with metastatic colorectal cancer starting first-line anti-EGFR therapy (cetuximab or panitumumab) are eligible for this trial comparing topical tretinoin (a retinoic acid derivative with comedolytic and immunomodulatory effects) versus placebo moisturizer, applied to opposite sides of the face, for prevention of anti-EGFR-induced acneiform rash.

ClinicalTrials.gov ID: NCT06358677

A Phase 1a/1b, First-in-human, Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients with Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)

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.

TrialFetch AI summary: Patients with advanced or metastatic relapsed/refractory adenoid cystic carcinoma or colorectal carcinoma whose standard treatment is ineffective, unsuitable, or unavailable receive once-daily oral RGT-61159. This investigational agent is designed to alter MYB RNA splicing, promote MYB RNA degradation, and reduce MYB expression.

ClinicalTrials.gov ID: NCT06462183

A Phase IIa, Non-Randomized, Open-Label Dose Expansion Trial of Isunakinra in Combination With Pembrolizumab in Patients With Metastatic or Unresectable, Locally 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.

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

TrialFetch AI summary: This study enrolls previously treated patients with metastatic or unresectable locally advanced RAS-mutant, microsatellite-stable/mismatch-repair-proficient colorectal adenocarcinoma and tumor mutational burden ≥10 mutations/Mb who have no remaining treatment likely to provide clinical benefit. Patients receive isunakinra, an investigational IL-1 receptor type 1 blocker, plus the PD-1 inhibitor pembrolizumab.

ClinicalTrials.gov ID: NCT06634875

Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy

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.

TrialFetch AI summary: Adults with previously treated unresectable or metastatic colorectal adenocarcinoma receive investigational ulixertinib, an ERK1/2 inhibitor, plus cetuximab after prior benefit from anti-EGFR therapy, or ulixertinib plus cetuximab and encorafenib if they have BRAF V600E–mutant disease previously treated with BRAF-directed and anti-EGFR therapy.

ClinicalTrials.gov ID: NCT05985954

A Phase I/II, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With BNT327 and Chemotherapy in Participants 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.

TrialFetch AI summary: This trial enrolls patients with unresectable, measurable, non-MSI-H/pMMR metastatic colorectal cancer and ECOG 0–1; prior-treatment requirements vary by cohort, including a previously untreated cohort. It evaluates BNT314, an EpCAM×4-1BB bispecific antibody, with BNT327, a PD-L1×VEGF-A bispecific antibody, with or without chemotherapy; the randomized portion compares the combination plus chemotherapy against BNT327 plus chemotherapy and bevacizumab plus chemotherapy.

ClinicalTrials.gov ID: NCT07079631

Safely Optimizing Body Weight With TCMCB07 in Patients With Newly Diagnosed Metastatic Colorectal Cancer Undergoing Chemotherapy

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

TrialFetch AI summary: Adults with newly diagnosed metastatic colorectal adenocarcinoma starting their second cycle of first-line chemotherapy receive daily subcutaneous TCMCB07 (mifomelatide) or placebo for 12 weeks. TCMCB07 is an investigational MC3/MC4 receptor antagonist being studied to preserve body weight and muscle mass during chemotherapy.

ClinicalTrials.gov ID: NCT06937177