Clinical Trials for Rectal Cancer

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.

TrialFetch 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

An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ 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.

TrialFetch AI summary: This trial enrolls adults with previously untreated, HER2-positive, RAS wild-type metastatic colorectal cancer to compare standard first-line mFOLFOX6-based regimens versus mFOLFOX6 combined with trastuzumab and tucatinib, a selective oral HER2 tyrosine kinase inhibitor. Eligible patients may have stable, treated brain metastases.

ClinicalTrials.gov ID: NCT05253651

An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment With Melphalan/HDS Followed by Consolidation Treatment With Trifluridine-Tipiracil Plus Bevacizumab Versus Trifluridine-Tipiracil Plus Bevacizumab Alone in Patients With Refractory Metastatic Colorectal Cancer With Liver Dominant Disease

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 refractory metastatic colorectal cancer and liver-dominant disease (≤50% liver involvement; limited extrahepatic disease allowed; ECOG 0–1) are randomized to induction hepatic-directed high-dose melphalan via the Delcath system (regional chemotherapy that isolates hepatic circulation to intensify cytotoxic exposure) followed by trifluridine–tipiracil plus bevacizumab, versus trifluridine–tipiracil plus bevacizumab alone. Prior exposure to fluoropyrimidine, oxaliplatin, irinotecan, anti-VEGF, and anti-EGFR (if RAS WT) is required; key exclusions include significant hepatic dysfunction, portal/venous thrombosis, major cardiopulmonary comorbidity, prior arterial liver-directed therapy, and peritoneal disease.

ClinicalTrials.gov ID: NCT06607458

Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen

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.

TrialFetch AI summary: Adults with metastatic or locally advanced/inoperable GI cancers (colorectal and non-colorectal; ECOG 0–1; excluding dMMR/MSI-H, known DPD deficiency, and prior oxaliplatin/fluoropyrimidine) receive an oxaliplatin/leucovorin backbone with infusional 5-FU, using an adaptive algorithm to escalate 5-FU from 2,400 to up to 3,200 mg/m2 over early cycles based on tolerance. Investigational aspect is individualized 5-FU dose escalation within a FOLFOX-like regimen to optimize dose intensity and assess response, PFS, and PK correlations.

ClinicalTrials.gov ID: NCT05780684

A Randomized Phase 2 Trial of Flat Dose vs. Weight-based Dose of Intra-peritoneal (IP) Chemotherapy for Patients Undergoing Cytoreductive Surgery and Heated Intra-peritoneal Chemotherapy (CRS/HIPEC) for Advanced Gastrointestinal Malignancy

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.

TrialFetch AI summary: Adults with peritoneal carcinomatosis from colorectal or appendiceal primaries undergoing cytoreductive surgery are randomized to HIPEC mitomycin C given as a fixed total dose (40 mg) versus weight-based dosing (12.5 mg/m2). Both arms use mitomycin C, a DNA crosslinking cytotoxic antibiotic, with the study focused on pharmacokinetics and potential reduction of systemic exposure/toxicity.

ClinicalTrials.gov ID: NCT04779554

A Multicenter, Open-label Phase 1/2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-201, an Antibody-drug Conjugate, in Advanced Refractory Solid Tumors

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/metastatic solid tumors refractory to standard therapy (mCRPC, metastatic breast cancer subtypes including TNBC, HR+/HER2− or HER2-low, HR−/HER2+, NSCLC, CRC, PDAC) receive MBRC-201, an investigational antibody‑drug conjugate targeting a tumor-associated antigen and delivering a likely topoisomerase I inhibitor payload. Requires ECOG 0–2 and measurable disease in expansion/Phase 2; excludes active CNS disease and prior camptothecin‑payload ADCs in later phases.

ClinicalTrials.gov ID: NCT07145255

A Single-Arm, Phase II Study of Autophagy Modulation Using Hydroxychloroquine in Combination With Encorafenib and Cetuximab or Panitumumab in Metastatic BRAF-mutated Colorectal Cancer Refractory to Standard Therapies

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.

TrialFetch AI summary: Adults with metastatic, BRAF V600E–mutated colorectal cancer after at least one prior systemic therapy (no prior BRAF/MEK inhibitors; ECOG 0–1; stable treated brain mets allowed) receive encorafenib plus an anti-EGFR antibody (cetuximab or panitumumab) combined with hydroxychloroquine. Hydroxychloroquine is an autophagy/lysosomal inhibitor intended to overcome resistance to MAPK pathway blockade and potentially enhance response to BRAF/EGFR-targeted therapy.

ClinicalTrials.gov ID: NCT05576896

Dual Administration Of Intraperitoneal And Intravenous TROP2-Directed CAR-NK With TGF-Beta Receptor 2 (TGFBR2) Knock Out (KO) Therapy For Colorectal Cancer-Related Peritoneal Carcinomatosis: A Phase 1/2 Trial ("Chip-CRC 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.

TrialFetch AI summary: Adults with microsatellite-stable colorectal cancer and peritoneal-predominant metastases not suitable for curative cytoreduction/HIPEC, after progression on or intolerance to at least one standard systemic chemotherapy, receive lymphodepleting cyclophosphamide/fludarabine. Treatment is dual IV and intraperitoneal TROP2-directed CAR-NK cells engineered to express IL-15 and lack TGFBR2, combined with IV cetuximab to target EGFR and potentially enhance NK-cell ADCC.

ClinicalTrials.gov ID: NCT07411599

Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and Colorectal Cancers

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 involves patients with locally advanced or metastatic pancreatic, lung, breast, and colorectal cancers who have progressed after standard treatments and exhibit tumor uptake of [68Ga]Ga-NNS309. It evaluates the safety and preliminary activity of the investigational radioligand [177Lu]Lu-NNS309, which targets specific tumor markers, though its exact mechanism of action is undisclosed.

ClinicalTrials.gov ID: NCT06562192

A Phase 1b/2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination with Ipilimumab Followed by Nivolumab Monotherapy in Patients with Locally Advanced or Metastatic Cancers Following One or More Prior Therapies

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 involves patients with advanced or metastatic solid tumors, such as melanoma and non-small cell lung cancer, who have had prior therapies, evaluating the safety and efficacy of Alintegimod, an integrin-targeting agent, combined with ipilimumab and nivolumab.

ClinicalTrials.gov ID: NCT06362369