Clinical Trials for Rectal Cancer

Phase 1/1B Study of DS-8201a in Combination With ATR Inhibition (AZD6738) in Advanced Solid Tumors With HER2 Expression (DASH Trial)

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, unresectable or metastatic HER2-expressing or HER2-amplified solid tumors receive trastuzumab deruxtecan, a HER2-directed antibody–drug conjugate carrying a topoisomerase I inhibitor, plus the oral ATR inhibitor ceralasertib. Expansion cohorts are limited to patients with gastroesophageal or colorectal cancer and a biopsiable lesion.

ClinicalTrials.gov ID: NCT04704661

A Study of PARG Inhibitor IDE161 in Participants With 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 or metastatic non-CNS solid tumors and a BRCA1/2 or other specified homologous-recombination repair alteration receive the investigational oral PARG inhibitor IDE161 alone after progression on or intolerance to standard therapy. A separate cohort with recurrent or advanced endometrial cancer progressing after anti-PD-1/PD-L1 therapy receives IDE161 plus pembrolizumab.

ClinicalTrials.gov ID: NCT05787587

Ablative Dose Single Fraction MRguided Colorectal Liver Metastasis SBRT

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 1-3 measurable colorectal cancer liver metastases (with specific size/location criteria), ECOG 0-2, and no cirrhosis, including those with prior therapies or extrahepatic disease, to receive a single 40 Gy fraction of MR-guided, adaptive SBRT for local control.

ClinicalTrials.gov ID: NCT06130280

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

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 single-arm study enrolls patients aged 1–21 with recurrent or refractory solid tumors, non-Hodgkin lymphoma, or desmoid tumors, with expansion cohorts for selected tumors and Wnt-pathway aberrations extending eligibility to age 30. Patients receive IV tegavivint on days 1, 8, and 15 of each 28-day cycle; it targets TBL1 to disrupt β-catenin–dependent Wnt signaling.

ClinicalTrials.gov ID: NCT04851119

A Phase 1/2 Study of FOG-001 in Participants With Locally Advanced or Metastatic 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 ECOG 0–1 and locally advanced or metastatic solid tumors are eligible for tumor-specific cohorts, including non-MSI-H/non-dMMR colorectal cancer, Wnt-pathway–altered tumors, hepatocellular carcinoma, desmoid tumors, and metastatic castration-resistant prostate cancer. Intravenous FOG-001 (zolucatetide), a β-catenin–binding peptide designed to disrupt β-catenin–TCF signaling, is given alone or with mFOLFOX-6/bevacizumab, nivolumab, or trifluridine/tipiracil/bevacizumab.

ClinicalTrials.gov ID: NCT05919264

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, ECOG 0–1, and an eligible biomarker are assigned to biomarker-directed combination arms. Regimens pair the PI3Kα inhibitor inavolisib, anti-TIGIT antibody tiragolumab, CDK7 inhibitor SY-5609, or KRAS G12C inhibitor divarasib with cetuximab, bevacizumab, atezolizumab, and/or FOLFOX or FOLFIRI, depending on the arm.

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