Clinical Trials for Rectal Cancer

A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable 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 metastatic microsatellite-stable colorectal adenocarcinoma, ECOG 0–1, and no BRAF V600E mutation receive first-line FOLFOX and bevacizumab plus either INCA33890 or placebo. INCA33890 is an investigational bispecific antibody targeting PD-1 and TGFβR2.

ClinicalTrials.gov ID: NCT07284849

A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)

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 metastatic colorectal cancer previously treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, and with no more than two prior metastatic regimens, are randomized to precemtabart tocentecan alone, precemtabart tocentecan plus bevacizumab, or trifluridine/tipiracil plus bevacizumab. Precemtabart tocentecan is a CEACAM5-directed antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan.

ClinicalTrials.gov ID: NCT07549412

An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory 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 c-Met–overexpressing refractory metastatic colorectal cancer who have not received a c-Met–targeting agent are randomized to telisotuzumab adizutecan plus bevacizumab or trifluridine/tipiracil plus bevacizumab. Telisotuzumab adizutecan is a c-Met–targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor.

ClinicalTrials.gov ID: NCT07525206

A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)

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

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, progressive recurrent or metastatic solid tumors across 13 cohorts receive intravenous ifinatamab deruxtecan, generally every 3 weeks. This investigational antibody–drug conjugate targets B7-H3 (CD276) and delivers a topoisomerase I inhibitor payload.

ClinicalTrials.gov ID: NCT06330064

AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With c-Met Over-Expressed Refractory 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

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 c-Met–overexpressing refractory metastatic colorectal cancer, ECOG performance status 0–1, and no prior c-MET–targeting antibody or antibody–drug conjugate receive intravenous ABBV-400 or trifluridine/tipiracil plus bevacizumab. ABBV-400 is an investigational c-Met–targeted antibody–drug conjugate that delivers a topoisomerase-1 inhibitor payload.

ClinicalTrials.gov ID: NCT06614192

A Phase II, Open-label, Multicenter, Master Protocol to Evaluate the Safety and Efficacy of Novel Study Interventions and Combinations in Participants With Colorectal Cancer (CANTOR)

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

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 untreated, measurable pMMR/MSS metastatic colorectal adenocarcinoma without liver metastases are randomized to first-line FOLFIRI plus bevacizumab with or without volrustomig. Volrustomig is an investigational bispecific antibody targeting PD-1 and CTLA-4.

ClinicalTrials.gov ID: NCT06792695

Phase II Open-Label Multi-Cohort Study Evaluating CPI-613 (Devimistat) in Combination With Hydroxychloroquine and 5-fluorouracil or Gemcitabine in Patients With Advanced Chemorefractory Colorectal, Pancreatic, or Other Solid Cancers

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.

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 measurable metastatic colorectal, pancreatic, biliary, gastroesophageal, urothelial, ovarian, or nonsquamous non-small cell lung cancer that is refractory to or intolerant of standard treatment receive devimistat, an investigational inhibitor of mitochondrial pyruvate dehydrogenase and α-ketoglutarate dehydrogenase complexes. It is combined with hydroxychloroquine and 5-fluorouracil for colorectal, pancreatic, and gastroesophageal cancers, or with gemcitabine and hydroxychloroquine for urothelial, ovarian, and lung cancers; the biliary regimen is described as devimistat with gemcitabine or hydroxychloroquine.

ClinicalTrials.gov ID: NCT05733000

A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects 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

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 measurable metastatic colorectal cancer and ECOG performance status 0–1 are eligible; prior c-Met–targeted therapy or irinotecan or another topoisomerase inhibitor is excluded. The study tests telisotuzumab adizutecan, a c-Met–targeting antibody–drug conjugate that delivers a topoisomerase I inhibitor, with FOLFOX/bevacizumab or fluorouracil/leucovorin/panitumumab, compared with regimens without telisotuzumab adizutecan.

ClinicalTrials.gov ID: NCT06820463

A Randomized, Open-label, Phase 2b Study to Compare the Efficacy of DSP107 in Combination With Atezolizumab Versus Fruquintinib in Patients With Advanced Microsatellite Stable 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

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 inoperable, measurable microsatellite-stable or mismatch repair–proficient colorectal cancer after up to three prior treatment lines are randomized to DSP107 plus atezolizumab or fruquintinib. DSP107 is an investigational SIRPα–4-1BBL fusion protein designed to block CD47–SIRPα signaling and stimulate T and NK cells.

ClinicalTrials.gov ID: NCT07235293

A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, With and Without an Anti-EGFR Antibody, and With an Anti-EGFR Antibody and Chemotherapy, in Patients With Metastatic KRAS G12D-Mutated Colorectal Adenocarcinoma (TARGET-D 203)

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

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 metastatic KRAS G12D-mutated colorectal adenocarcinoma and ECOG 0–1 receive investigational oral VS-7375, an inhibitor of active and inactive KRAS G12D. Previously treated patients receive it alone or with cetuximab or panitumumab; first-line patients receive it with cetuximab and mFOLFOX6.

ClinicalTrials.gov ID: NCT07659795