Clinical Trials for Rectal Cancer

Pilot Study Evaluating Microbiome Modulation Therapy (MBMT) With Ciprofloxacin, Metronidazole, and Aspirin in Addition to Standard of Care Chemotherapy in Patients Undergoing First-Line Therapy for 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.

TrialFetch AI summary: Adults with newly diagnosed metastatic (stage IV) colorectal cancer eligible for first-line 5-fluorouracil-based doublet chemotherapy are randomized to standard chemotherapy with or without an investigational microbiome modulation therapy (MBMT) consisting of oral ciprofloxacin, metronidazole, and low-dose aspirin, aiming to assess whether altering the gut microbiome improves treatment response. Patients with recent antibiotic use, high bleeding risk, or MBMT drug allergies are excluded.

ClinicalTrials.gov ID: NCT06728072

A Randomized, Open-label Phase 3 Study of Amivantamab + FOLFIRI Versus Cetuximab/Bevacizumab + FOLFIRI in Participants With KRAS/NRAS and BRAF Wild-type Recurrent, Unresectable or Metastatic Colorectal Cancer Who Have Received Prior Chemotherapy

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 recurrent, unresectable, or metastatic KRAS/NRAS/BRAF wild-type colorectal cancer who have progressed after prior fluoropyrimidine- and oxaliplatin-based chemotherapy, randomizing them to receive either amivantamab (a bispecific EGFR/MET antibody) plus FOLFIRI or standard of care FOLFIRI with either cetuximab or bevacizumab. Prior irinotecan, EGFR, MET, or HER2-targeted therapies are exclusionary.

ClinicalTrials.gov ID: NCT06750094

Sequential Combined TAS-102 and Oxaliplatin Alternating With TAS-102 and Irinotecan (Sequential TASOXIRI) With Bevacizumab for Late-Line 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.

TrialFetch AI summary: This trial enrolls adults with metastatic colorectal cancer who have progressed after standard chemotherapies (including 5-FU, oxaliplatin, irinotecan, and appropriate antibody therapies), evaluating a sequential regimen of TAS-102 (nucleoside metabolic inhibitor) alternating with oxaliplatin and irinotecan plus bevacizumab. Patients must not have had prior TAS-102 exposure and should have good performance status and organ function.

ClinicalTrials.gov ID: NCT05806931

Randomized Phase II Trial of 5-Fluorouracil/Leucovorin (5FU/LV) in Combination With Regorafenib in Patients With 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.

TrialFetch AI summary: Adults with metastatic colorectal cancer who have failed at least two prior lines of therapy and meet standard eligibility criteria are randomized to receive either 5-fluorouracil/leucovorin with regorafenib (an oral multikinase inhibitor targeting angiogenic, stromal, and oncogenic pathways) or trifluridine-tipiracil plus bevacizumab.

ClinicalTrials.gov ID: NCT06887218

A Phase 1/2 Study of Tegavivint (NSC#826393) in Children, Adolescents, and Young Adults With Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid 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 children, adolescents, and young adults with recurrent or refractory solid tumors (including lymphomas and desmoid tumors), treating them with intravenous tegavivint, a small molecule inhibitor targeting TBL1 to disrupt Wnt/beta-catenin signaling. Expansion cohorts focus on specific tumor types and Wnt pathway–driven malignancies.

ClinicalTrials.gov ID: NCT04851119

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