Clinical Trials for Rectal Cancer

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

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.

TrialFetch AI summary: This trial enrolls patients with previously treated unresectable or metastatic colorectal cancer, advanced pancreatic ductal adenocarcinoma, or advanced or unresectable biliary tract cancer; one biliary tract cohort also allows patients without prior systemic therapy. Patients receive sacituzumab tirumotecan, an investigational TROP2-targeted antibody–drug conjugate delivering a topoisomerase I inhibitor, alone or with fluorouracil/leucovorin or cisplatin/pembrolizumab.

ClinicalTrials.gov ID: NCT06428409

A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With 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.

TrialFetch AI summary: Patients with unresectable locally advanced or metastatic upper gastrointestinal cancer receive investigational CHS-114, an anti-CCR8 antibody designed to deplete tumor-infiltrating regulatory T cells, plus the anti-PD-1 antibody toripalimab. Eligible groups include previously treated HER2-negative, MSS/pMMR gastric, gastroesophageal junction, or esophageal adenocarcinoma and previously treated esophageal squamous cell carcinoma (ESCC); untreated advanced ESCC receives the combination with 5-fluorouracil and cisplatin.

ClinicalTrials.gov ID: NCT06657144

A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants 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.

TrialFetch AI summary: Adults with advanced solid tumors that have progressed after at least one systemic therapy receive FT836, an off-the-shelf, induced pluripotent stem cell–derived CAR T-cell therapy targeting MICA/MICB. FT836 is given alone or with paclitaxel, cetuximab, or trastuzumab, including paclitaxel–antibody combinations.

ClinicalTrials.gov ID: NCT07216105