Clinical Trials for Rectal Cancer

A Phase 2, Open-label, Multicenter Study of IBI363 (PD1-IL2m) in Subjects with Advanced Solid Malignancies

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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with advanced, refractory solid tumors and ECOG performance status 0–1 receive intravenous IBI363 every 2 or 3 weeks. IBI363 is an investigational PD-1/IL-2α-biased fusion protein designed to combine PD-1 blockade with IL-2 signaling directed preferentially toward PD-1-positive T cells.

ClinicalTrials.gov ID: NCT06281678

A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations

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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with unresectable or metastatic solid tumors other than NSCLC that harbor an activating HER2 mutation are eligible after appropriate standard therapy or when no satisfactory alternative exists; prior HER2 tyrosine kinase inhibitor treatment and active brain metastases are excluded. All participants receive oral sevabertinib, a reversible HER2-directed tyrosine kinase inhibitor, 20 mg twice daily.

ClinicalTrials.gov ID: NCT06760819

A Phase 2, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of NGM120 in Participants With Colorectal Cancer Who Have Cancer Cachexia

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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with active colorectal cancer and cachexia are randomized to subcutaneous NGM120 or placebo every 4 or 8 weeks, depending on the treatment group. NGM120 is an investigational antibody that blocks GFRAL, the receptor for GDF15, to counter signaling associated with appetite suppression and weight loss.

ClinicalTrials.gov ID: NCT07033026

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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with CCR5-positive, microsatellite-stable, unresectable metastatic colorectal cancer previously treated with standard chemotherapy and targeted therapy receive trifluridine/tipiracil plus bevacizumab with either 350 mg or 700 mg of leronlimab, an investigational anti-CCR5 monoclonal antibody. Eligible patients must have measurable disease and ECOG performance status 0–1; there is no arm without leronlimab.

ClinicalTrials.gov ID: NCT06699836

Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic 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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with previously treated metastatic colorectal adenocarcinoma receive ivonescimab, an investigational bispecific antibody targeting PD-1 and VEGF-A. Cohorts include dMMR/MSI-H disease progressing after PD-1/PD-L1 therapy and pMMR/MSS disease, with or without active liver metastases, progressing after or intolerant to fluoropyrimidine, irinotecan, and oxaliplatin.

ClinicalTrials.gov ID: NCT06959550

A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 Versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012)

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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: For patients with KRAS G12C-mutant, locally advanced unresectable or metastatic colorectal adenocarcinoma who have not received systemic therapy for advanced disease, this study compares first-line mFOLFOX6 plus cetuximab and calderasib (MK-1084), an investigational covalent KRAS G12C inhibitor, with mFOLFOX6 with or without bevacizumab.

ClinicalTrials.gov ID: NCT06997497

AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC 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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with previously untreated metastatic colorectal adenocarcinoma, ECOG 0–1, and measurable disease are eligible; key exclusions include BRAF V600E–mutant and MSI-high/dMMR disease. Participants receive chemotherapy plus either PF-08634404, an investigational bispecific antibody targeting PD-1 and VEGF, or bevacizumab.

ClinicalTrials.gov ID: NCT07222800

ROSETTA CRC-203: A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic 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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with previously untreated, unresectable recurrent or metastatic colorectal adenocarcinoma are eligible, excluding those with known dMMR/MSI-H disease or a BRAF V600E mutation. The trial compares first-line chemotherapy (FOLFOX, FOLFIRI, or CAPOX) plus pumitamig, an investigational PD-L1/VEGF-A bispecific antibody, with the same chemotherapy plus bevacizumab.

ClinicalTrials.gov ID: NCT07221357

A Randomized, Open Label, Multicenter, Phase 2 Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo® in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care for First-line Treatment of Non-MSI-H/dMMR, PD-L1 Positive 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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: Adults with previously untreated, unresectable locally advanced or metastatic PD-L1-positive colorectal cancer that is non-MSI-H/dMMR and BRAF V600E–negative receive first-line mFOLFOX6 plus bevacizumab alone or with nivolumab and one of two doses of ONO-4578, an oral prostaglandin E2 receptor EP4 antagonist.

ClinicalTrials.gov ID: NCT06948448

A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination With FOLFOX Versus Bevacizumab in Combination With FOLFOX for the First-line Treatment of Metastatic 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.

Active drug

Investigational drug(s) in this trial have shown anticancer activity in clinical trials

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.

TrialFetch AI summary: This trial enrolls patients with unresectable metastatic colorectal cancer who have ECOG performance status 0–1 and have not received systemic therapy for metastatic disease; MSI-H/dMMR and BRAF V600E–mutant disease are excluded. Patients receive mFOLFOX6 followed by fluorouracil/leucovorin maintenance, with either ivonescimab, a bispecific antibody targeting PD-1 and VEGF-A, or bevacizumab.

ClinicalTrials.gov ID: NCT07228832