Clinical Trials for Colon Cancer

A Phase Ib Study to Evaluate Safety and Persistence of Ex Vivo Expanded Universal Donor NK Cells in Combination with IL-2 and TGFbeta Receptor I Inhibitor Vactosertib in Patients with Locally Advanced/metastatic Colorectal Cancer, Gastric/esophageal Cancer, and Relapsed/refractory Hematologic Malignancies

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.

HealthScout AI summary: This trial enrolls adults with locally advanced/metastatic colorectal, gastric, or esophageal cancer, or relapsed/refractory hematologic malignancies who have progressed on standard therapies or are ineligible, and treats them with fludarabine/cyclophosphamide lymphodepletion followed by ex vivo expanded universal donor NK cell infusions combined with low-dose IL-2 and vactosertib, a TGFβ receptor I (ALK5) inhibitor designed to enhance NK cell activity by blocking TGFβ-mediated immunosuppression.

ClinicalTrials.gov ID: NCT05400122

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.

HealthScout AI summary: This trial enrolls adults with refractory, BRAF V600E-mutant metastatic colorectal cancer who have previously tolerated encorafenib plus cetuximab, and evaluates the addition of ZEN003694, a pan-BET bromodomain inhibitor, to ongoing encorafenib and cetuximab therapy. Patients must have good performance status and adequate organ function, and may have stable or treated brain metastases.

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.

HealthScout AI summary: This trial enrolls adults with microsatellite stable, KRAS-mutant metastatic colorectal cancer who have progressed on or are intolerant of standard chemotherapy, and excludes those with diabetes or prior anti-PD1/CTLA-4 therapy. Patients receive combination therapy with botensilimab (Fc-engineered anti-CTLA-4 antibody), balstilimab (anti-PD-1 antibody), a fasting-mimicking diet, and high-dose intravenous vitamin C.

ClinicalTrials.gov ID: NCT06336902

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.

HealthScout 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

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.

HealthScout AI summary: This trial enrolls adults with previously untreated, unresectable or metastatic colorectal adenocarcinoma (excluding MSI-H/dMMR) to receive FOLFOX and bevacizumab combined with emavusertib (CA-4948), a selective IRAK4 inhibitor targeting the TLR/IL-1R/NF-κB pathway. Key exclusions include prior FOLFOX, bevacizumab, or antiangiogenic therapy in the metastatic setting.

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.

HealthScout AI summary: This trial enrolls adults with metastatic colorectal cancer who have progressed on standard therapies (including post-checkpoint inhibitor for MSI-H/dMMR) to receive combination immunotherapy with retifanlimab (PD-1 inhibitor), TriAdeno vaccine (targets CEA, MUC1, brachyury), N-803 (IL-15 agonist), and SX-682 (oral CXCR1/2 inhibitor targeting myeloid-derived suppressor cell trafficking). The regimen is designed for patients with measurable disease and good performance status, including those with microsatellite stable tumors typically resistant to immunotherapy.

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.

HealthScout 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 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

HealthScout AI summary: This trial enrolls adults with metastatic or unresectable, locally advanced colorectal adenocarcinoma that is microsatellite stable, has high tumor mutational burden (≥10), and a RAS mutation, who have progressed after standard therapies. Patients receive isunakinra, a systemic IL-1 receptor inhibitor, in combination with pembrolizumab.

ClinicalTrials.gov ID: NCT06634875

Probiotics Preventing Immune Checkpoint Inhibitor-Induced Colitis

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.

HealthScout AI summary: Adults with solid tumors (ECOG ≤2) starting immune checkpoint inhibitor therapy—with or without chemotherapy—receive VSL#3 probiotic in addition to standard immunotherapy to assess whether it reduces the incidence of ICI-induced colitis. Patients with significant GI or autoimmune comorbidities, recent antibiotics, or immunosuppression are excluded.

ClinicalTrials.gov ID: NCT06508034

A Phase Two Study Evaluating Two Doses of Leronlimab (Pro 140) In Combination With Trifluridine + Tipiracil (TAS-102) + Bevacizumab in Participants With CCR5+, Microsatellite Stable (MSS), Relapsed Refractory Metastatic Colorectal Cancer (mCRC)

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

HealthScout AI summary: This trial enrolls adults with CCR5-positive, microsatellite stable, relapsed/refractory metastatic colorectal cancer who have progressed after standard therapies, to evaluate the addition of leronlimab—a CCR5-targeting monoclonal antibody—to trifluridine/tipiracil and bevacizumab. Patients are randomized to receive one of two dosing levels of leronlimab in combination with standard chemotherapy.

ClinicalTrials.gov ID: NCT06699836