Clinical Trials for Rectal Cancer

A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

Active drug

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

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.

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 metastatic colorectal adenocarcinoma whose tumors harbor specific biomarkers are assigned to various arms testing targeted agents—including the PI3Kα inhibitor inavolisib, TIGIT inhibitor tiragolumab (with anti–PD-L1 and bevacizumab), CDK7 inhibitor SY-5609, and KRAS G12C inhibitor divarasib (with chemotherapy or EGFR/VEGF antibodies)—according to their molecular profile.

ClinicalTrials.gov ID: NCT04929223

A Single Arm Phase 4 Trial to Evaluate the Safety and Efficacy of Oral Fruquintinib in the Treatment of Refractory Metastatic Colorectal Cancer in Patients From Minority Populations Underrepresented in Prior Fruquintinib Studies

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 adult patients with refractory metastatic colorectal adenocarcinoma who self-identify as Black/African American or Hispanic/Latino and have ECOG 0–1, treating them with oral fruquintinib, a VEGFR 1/2/3 inhibitor, to assess safety—particularly incidence of hypertension—and efficacy in this underrepresented population.

ClinicalTrials.gov ID: NCT06562543

Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

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 treatment-naïve adults with metastatic colorectal adenocarcinoma harboring a KRAS p.G12C mutation and randomizes them to receive either sotorasib (a KRAS G12C inhibitor), panitumumab, and FOLFIRI, or FOLFIRI with or without bevacizumab-awwb. Excludes include prior KRAS G12C inhibitor use, untreated CNS metastases, and significant pulmonary disease.

ClinicalTrials.gov ID: NCT06252649

A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01)

Active drug

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

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.

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 adults with refractory or metastatic colorectal cancer who have progressed after standard therapies, including immunotherapy for MSI-high tumors. Patients receive M9140, an antibody-drug conjugate targeting CEACAM5 and delivering a topoisomerase 1 inhibitor (exatecan), either alone or in combination with metastatic colorectal cancer standard regimens (bevacizumab, capecitabine, or 5-FU/folinic acid).

ClinicalTrials.gov ID: NCT05464030

A Randomized, Open-label Phase 3 Study of Amivantamab and mFOLFOX6 or FOLFIRI Versus Cetuximab and mFOLFOX6 or FOLFIRI as First-line Treatment in Participants With KRAS/NRAS and BRAF Wild-type Unresectable or Metastatic Left-sided 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.

TrialFetch AI summary: This trial enrolls adults with unresectable or metastatic, left-sided colorectal adenocarcinoma that is KRAS, NRAS, and BRAF wild-type, and compares amivantamab (a bispecific EGFR/MET antibody) plus standard chemotherapy (mFOLFOX6 or FOLFIRI) to cetuximab plus the same chemotherapy as first-line treatment. Key exclusions include prior EGFR or MET inhibitor use, dMMR/MSI-H, or HER2-positive tumors.

ClinicalTrials.gov ID: NCT06662786

A Phase II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic Colorectal Cancer or Hepatocellular Carcinoma

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 adults with advanced or metastatic colorectal cancer (after 2-3 prior therapies) or hepatocellular carcinoma (after 1-2 prior therapies), who have good performance status and organ function. All patients receive enfortumab vedotin, an antibody-drug conjugate targeting Nectin-4 that delivers MMAE to tumor cells, administered intravenously every 28 days.

ClinicalTrials.gov ID: NCT06553885

A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients With Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery (ERASur)

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 adults with newly diagnosed, limited (≤4 sites, non-liver-only, non-peritoneal) metastatic colorectal adenocarcinoma who have not progressed after first-line systemic therapy, randomizing them to standard chemotherapy with or without total ablative therapy (SABR, surgical resection, and/or microwave ablation) to all metastatic sites. Patients with MSI-H or BRAF V600E-mutated tumors are excluded.

ClinicalTrials.gov ID: NCT05673148

An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including Sarcomas

Active drug

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

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.

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 locally advanced or metastatic solid tumors—including specific cohorts for Ewing sarcoma, colorectal adenocarcinoma, malignant pleural mesothelioma, gastric adenocarcinoma, and SDH-deficient/GIST—who receive INBRX-109, a tetravalent agonistic DR5 antibody that induces tumor cell apoptosis, as monotherapy or in combination with standard chemotherapy regimens. Eligible patients must have measurable disease, good organ function and performance status, and no prior DR5 agonist exposure.

ClinicalTrials.gov ID: NCT03715933

An Open-label Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors

Active drug

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

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.

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 adults with unresectable hepatocellular carcinoma, metastatic colorectal cancer, or advanced solid tumors (including endometrial carcinoma) who have progressed after standard therapies, testing the investigational oral agent E7386—a CBP/β-catenin interaction inhibitor targeting the Wnt/β-catenin pathway—in combination with lenvatinib or standard chemotherapy. The current dose optimization phase randomizes endometrial carcinoma patients to E7386 plus lenvatinib, lenvatinib monotherapy, or physician’s choice.

ClinicalTrials.gov ID: NCT04008797

First-in-Human, Phase 1/1b, Open-label, Multicenter Study of Bifunctional EGFR/TGFβ Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-Driven Advanced Solid Tumors

Active drug

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

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.

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 EGFR-driven solid tumors, with expansion in squamous histologies (cSCC post/PD-1-ineligible, first-line R/M HNSCC by CPS strata, ICI-naïve SCAC after 1–2 lines, and stage IV squamous NSCLC post 1 line), receive BCA101 (ficerafusp alfa) alone or with pembrolizumab. BCA101 is a bifunctional anti-EGFR/TGF-β “trap” antibody designed to inhibit EGFR and locally neutralize TGF-β1/3; requires measurable disease and mandatory biopsies, excludes prior anti–TGF-β and certain recent anti-EGFR exposure.

ClinicalTrials.gov ID: NCT04429542