Clinical Trials for Colon Cancer

Phase 1/2 Study of Neratinib and Divalproex Sodium (Valproate) in Advanced Solid Tumors, With an Expansion Cohort in Ras-Mutated Cancers

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.

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: Enrolling adults with advanced solid tumors—including RAS-mutated colorectal, pancreatic, other RAS-mutant tumors, EGFR-altered or RAS-mutant glioblastoma, and ocular melanoma (with GNAQ or GNA11 mutations)—this study tests oral neratinib (an irreversible pan-HER tyrosine kinase inhibitor) combined with divalproex sodium (a histone deacetylase inhibitor) in patients who have progressed on standard therapies.

ClinicalTrials.gov ID: NCT03919292

A Randomized Phase III Study of Systemic Therapy With or Without Hepatic Arterial Infusion for Unresectable Colorectal Liver Metastases: The PUMP Trial

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: Adults with unresectable, liver-only metastatic colorectal cancer (after 3–6 months of first-line chemotherapy, ECOG 0-1, no significant extrahepatic disease) are randomized to standard systemic chemotherapy (e.g., FOLFOX, FOLFIRI, or OX/IRI ± targeted agents) with or without hepatic arterial infusion of floxuridine, an antimetabolite delivered directly to the liver via an implanted pump.

ClinicalTrials.gov ID: NCT05863195

A Phase 1 Study of 5-Fluorouracil in Combination With Abemaciclib in Metastatic, Refractory CRC

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 (MSS) metastatic colorectal cancer refractory to standard therapies, testing the combination of oral abemaciclib (a selective CDK4/6 inhibitor that blocks cell cycle progression) with intravenous 5-fluorouracil. Prior CDK4/6 inhibitor use and intolerance to fluoropyrimidines are exclusion criteria.

ClinicalTrials.gov ID: NCT06654037

Phase I Trial of 5-Fluorouracil (5FU) -Based Therapy in Combination With Hydroxytyrosol (HT) in Patients With Advanced or Metastatic Colorectal Cancer

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 study enrolls adults with advanced or metastatic colorectal cancer (excluding dMMR/MSI-H) who are candidates for first-line 5-FU-based chemotherapy (FOLFIRI or FOLFOX ± biologics), testing the addition of oral hydroxytyrosol—a polyphenol with preclinical anti-inflammatory and immune modulatory effects—to standard treatment. Eligibility requires ECOG 0–1, measurable disease, and adequate organ function.

ClinicalTrials.gov ID: NCT06833866

Phase II Study of Hypofractionated Radiation Therapy to Augment Immune Response in Patients With Metastatic GastroIntestinal Malignancies Progressing on Immune Therapy (ARM-GI)

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.

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 gastrointestinal cancers (including esophageal, gastric, small intestine, hepatocellular, pancreaticobiliary, colorectal, or anal) who are progressing on a checkpoint or CTLA-4 inhibitor, treating them with hypofractionated external beam radiation (30 Gy in 5 fractions to 1-5 lesions) in addition to ongoing immunotherapy. The aim is to determine if radiation can enhance systemic immune response and improve outcomes in this refractory population.

ClinicalTrials.gov ID: NCT04221893

A Phase I Study of Intraperitoneal 5FU+Oxaliplatin in Patients with Colorectal Cancer with Isolated Peritoneal Metastasis

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 biopsy-proven colorectal cancer and isolated peritoneal metastases (PCI >20), without prior cytoreductive surgery, who receive intraperitoneal oxaliplatin and 5FU via a peritoneal port. It is designed to assess safety, tolerability, and dose parameters of this locoregional chemotherapy approach.

ClinicalTrials.gov ID: NCT06269978

Phase II Study of Infliximab for the Treatment of Immune Checkpoint Inhibitor Colitis

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.

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: Eligible patients are adults with stage III or IV skin cancer who develop endoscopically confirmed colitis after CTLA-4 inhibitor (± PD-1/PD-L1) therapy; they will be randomized to receive either infliximab, a TNF-α inhibitor, or standard corticosteroids, with crossover allowed for inadequate response.

ClinicalTrials.gov ID: NCT04305145

Phase II Trial of Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select 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.

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 left-sided, unresectable, metastatic, mismatch repair–proficient colorectal cancer without KRAS, NRAS, or BRAF V600 mutations to study panitumumab or cetuximab, alone or with chemotherapy, as early-line therapy, retreatment, or rechallenge based on prior anti-EGFR and chemotherapy exposure. Patients are assigned to cohorts according to their prior response and exposure to EGFR inhibitors and FOLFOX.

ClinicalTrials.gov ID: NCT04587128

A Multicenter Phase 1b/2 Study of Adagrasib, Cetuximab, and Cemiplimab for Metastatic Colorectal Cancer Harboring KRAS G12C Mutations

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: Adults with advanced or metastatic, microsatellite stable colorectal cancer harboring a KRAS G12C mutation who have progressed on at least one prior line of chemotherapy are eligible for combination therapy with adagrasib (a selective KRAS G12C inhibitor), cetuximab (anti-EGFR antibody), and cemiplimab (PD-1 inhibitor). Prior exposure to KRAS G12C or immune checkpoint inhibitors is excluded.

ClinicalTrials.gov ID: NCT06412198

Phase 1 Study With Dose Expansion of the Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma

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 unresectable, locally advanced, metastatic, or recurrent mesothelioma (epithelioid or biphasic with >80% epithelioid), or other solid tumors with high mesothelin expression (≥50% of tumor cells), who have progressed after standard therapies. Treatment involves lymphodepleting chemotherapy followed by a single infusion of autologous CAR T cells (TNhYP218) engineered to target a membrane-proximal epitope of mesothelin, using naive/stem cell memory T cells to potentially enhance efficacy.

ClinicalTrials.gov ID: NCT06885697