Clinical Trials for Rectal Cancer

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

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

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