Clinical Trials for Colon Cancer

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.

HealthScout AI summary: This trial enrolls adults with unresectable or metastatic colorectal adenocarcinoma who have progressed after prior EGFR or BRAF-targeted therapy, with wild-type or BRAF V600E-mutant tumors as appropriate for cohort allocation. Patients will receive the investigational ERK1/2 inhibitor ulixertinib (MAPK pathway inhibitor) with cetuximab, with or without encorafenib, depending on BRAF status.

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.

HealthScout AI summary: Adults with unresectable, MSS/pMMR metastatic colorectal adenocarcinoma (ECOG 0–1) are treated with BNT314 (bispecific EpCAM×4‑1BB agonist delivering EpCAM-restricted costimulation) plus BNT327 (bispecific PD‑L1×VEGF‑A inhibitor) with standard chemotherapy across lines of therapy, with Phase 2 randomization versus bevacizumab + chemotherapy or BNT327 + chemotherapy. Excludes MSI‑H/dMMR and prior EpCAM/4‑1BB, checkpoint inhibitor, or PD‑(L)1/VEGF bispecific exposure, and patients with uncontrolled CNS disease or significant cardiovascular/autoimmune risks.

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

HealthScout AI summary: Adults with newly diagnosed metastatic colorectal adenocarcinoma starting first-line q2‑week chemotherapy (FOLFOX/FOLFIRI/FOLFIRINOX ± bevacizumab/other biologics), ECOG 0–2 and BMI ≤29, are randomized at cycle 2 to daily subcutaneous TCMCB07 (mifomelatide) vs placebo for 12 weeks to preserve body weight and composition. TCMCB07 is a brain-penetrant cyclic peptide antagonist of MC4R/MC3R intended to counter cancer/chemo‑related anorexia and hypermetabolism; safety and weight change at 12 weeks are primary outcomes.

ClinicalTrials.gov ID: NCT06937177

Phase I Randomized Open Label Trial Investigating Adoptive Transfer of CD39+CD103+CD8+ Tumor-isolated T Cells (AGX148) Alone or Combined With siRNA Modulation of PD-1 (AGX148/PH-762) in Patients With Advanced 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: Adults with unresectable/metastatic solid tumors (post–standard therapy; prior ICI required for melanoma/HNSCC) undergo tumor harvest for autologous CD39+CD103+ CD8+ TIL therapy after cyclophosphamide/fludarabine lymphodepletion and IL-2 support. Patients are randomized to standard enriched TILs (AGX148) or the same product with ex vivo PD‑1 knockdown via self‑delivering siRNA PH‑762 (AGX148/PH‑762) to enhance effector function and persistence, with varying durations of low‑dose IL‑2 post-infusion.

ClinicalTrials.gov ID: NCT05902520

A Phase 1b/2a Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of TU2218, an Oral TGFβR Serine/Threonine Kinase Inhibitor, Administered in Combination With Pembrolizumab in Patients With Advanced 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: Adults with advanced unresectable/metastatic solid tumors lacking effective options receive TU2218 (oral dual ALK5/TGFBR1 and VEGFR2 inhibitor targeting TGF-β/VEGF-mediated immunosuppression) plus pembrolizumab; expansion cohorts include PD-(L)1–naïve or post-platinum HNSCC (PD-L1 CPS ≥1 for naïve), biliary tract cancer after standard therapy, and PD-(L)1–naïve pMMR/MSS colorectal cancer after ≥2 lines (excluding CRC with liver metastases). Suitable for ECOG 0–1; key exclusions include active CNS disease, significant cardiovascular disease, active autoimmune disease requiring systemic therapy, prior TGF-β inhibitors, prior PD-(L)1 in specified cohorts, and certain drug–drug interactions.

ClinicalTrials.gov ID: NCT05784688

A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers

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: Adults with unresectable/metastatic GI cancers—previously treated colorectal or pancreatic ductal adenocarcinoma, and biliary tract cancers (treatment‑naive or previously treated)—receive sacituzumab tirumotecan (MK‑2870), a TROP2‑targeted antibody–drug conjugate delivering a belotecan‑derived topoisomerase I inhibitor, as monotherapy or combined with 5‑FU/leucovorin, or with cisplatin plus pembrolizumab. Excludes significant ophthalmologic disease and prior steroid‑requiring ILD/pneumonitis; prior therapy toxicities must have resolved.

ClinicalTrials.gov ID: NCT06428409

A Phase 1, Open Label, Dose Escalation of HBI-2438 in Patients With Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation

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: The trial is recruiting adult patients with advanced malignant solid tumors harboring KRAS G12C mutations who have exhausted standard therapies, aiming to evaluate the safety and maximum tolerated dose of HBI-2438, an investigational oral small molecule that irreversibly targets and inactivates KRAS G12C.

ClinicalTrials.gov ID: NCT05485974

A Phase 1 Study of the Safety and Efficacy of CRX100 as Monotherapy and in Combination With Pembrolizumab in Advanced Solid 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.

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 targets adult patients with advanced solid malignancies and evaluates the safety and efficacy of CRX100, an investigational immunotherapy combining autologous T cells and oncolytic vaccinia virus, as monotherapy and in combination with Pembrolizumab.

ClinicalTrials.gov ID: NCT04282044

A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

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: The trial involves adult patients with advanced solid tumors harboring specific RAS mutations, including KRAS G12, who have progressed after standard therapies, evaluating the safety and tolerability of RMC-6236, an oral selective inhibitor targeting active RAS(ON) with a novel 'tri-complex' mechanism. This investigational drug shows promising early efficacy, especially in KRAS G12X-related pancreatic and non-small cell lung cancers.

ClinicalTrials.gov ID: NCT05379985

A Phase 1/2, Open-label, Dose-escalation, and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101 As a Single Agent and in Combination with Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients with Advanced or Metastatic Solid Tumors (Keynote B59)

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 involves adult patients with advanced or metastatic solid tumors and evaluates the safety and therapeutic activity of GI-101, a bispecific fusion protein targeting CTLA-4 and the IL-2 pathway, as a single agent and in combination with pembrolizumab, lenvatinib, or radiotherapy.

ClinicalTrials.gov ID: NCT04977453