Clinical Trials for Rectal Cancer

A Phase 1/2 Study of IDE196 in Patients with Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions

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 metastatic uveal melanoma or other measurable solid tumors harboring GNAQ/GNA11 mutations or PRKC fusions receive darovasertib (IDE196), an oral PKC inhibitor, alone or with the MEK inhibitor binimetinib or the MET/ALK/ROS1 inhibitor crizotinib. Eligibility requires ECOG performance status 0–1; prior PKC inhibitor treatment is excluded.

ClinicalTrials.gov ID: NCT03947385

Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)

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 GI cancers (esophagus/GEJ/gastric, small bowel, colorectal/appendiceal, biliary, HCC, pancreatic/ampullary) on a benefiting systemic regimen who develop up to 5 new/progressing lesions receive lesion-directed local ablation (SABR or IR ablation) while continuing the same systemic therapy. Aims to control oligoprogression and delay systemic therapy change; excludes contraindications to ablation or active brain progression.

ClinicalTrials.gov ID: NCT06101277

Phase 1/2 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 (Petosemtamab) as Single Agent or in Combination in 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: Open cohorts enroll patients with unresectable or metastatic microsatellite-stable, RAS/RAF wild-type colorectal cancer and ECOG 0–1; combination cohorts require no prior anti-EGFR therapy. Patients receive petosemtamab, an investigational EGFR/LGR5-targeting bispecific antibody, alone or with pembrolizumab, FOLFIRI, or FOLFOX.

ClinicalTrials.gov ID: NCT03526835

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients With 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 advanced or metastatic solid tumors, including ATM-altered cancers and platinum-resistant ovarian cancer, receive the oral ATR kinase inhibitor ART0380 (alnodesertib) alone or with gemcitabine or irinotecan. The ovarian cancer cohort compares ART0380 plus gemcitabine with gemcitabine alone.

ClinicalTrials.gov ID: NCT04657068

A Phase 1b/2a Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of TU2218, an Oral TGFβR Serine/Threonine Kinase Inhibitor, Administered in Combination With Pembrolizumab in Patients 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 unresectable or metastatic solid tumors lacking an effective standard treatment option receive TU2218, an oral TGF-β receptor I (ALK5) and VEGFR2 inhibitor, plus pembrolizumab, an anti-PD-1 antibody. Tumor-specific cohorts focus on biliary tract cancer, head and neck squamous cell carcinoma, and mismatch repair–proficient/microsatellite-stable colorectal cancer without liver metastases.

ClinicalTrials.gov ID: NCT05784688

Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy

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 GI adenocarcinomas (colorectal, pancreaticobiliary, or upper GI) progressing after standard therapy receive sacituzumab govitecan (Trop-2–targeted ADC delivering SN-38/topoisomerase I inhibitor) plus capecitabine in 21-day cycles; prior topo I inhibitor exposure is excluded, treated/stable brain mets allowed. Dose-escalation assesses safety/tolerability and seeks an RP2D, with exploratory correlation to tumor Trop-2 expression.

ClinicalTrials.gov ID: NCT06065371

Patient Preference for Subcutaneous vs. Intravenous Immune Therapy (PSI-Immune)

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 locally advanced or metastatic solid tumors eligible for on-label PD-1 therapy (nivolumab or pembrolizumab) are randomized in a crossover design to receive standard PD-1 inhibitors via subcutaneous versus intravenous administration, assessing patient/clinician preference, satisfaction, QoL, safety, and selected clinical outcomes. Includes PD-(L)1–naïve patients or those willing to switch; excludes prior severe hypersensitivity and transplant history.

ClinicalTrials.gov ID: NCT07223424

A Phase 1b/2 Study of AVUTOMETINIB and Cetuximab in Participants With Advanced KRAS Mutated Colorectal Cancer

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, measurable KRAS-mutated metastatic colorectal adenocarcinoma and ECOG performance status 0–1 receive oral avutometinib, a RAF/MEK clamp that suppresses ERK signaling, plus intravenous cetuximab, an EGFR-targeting antibody. This single-arm study evaluates dose tolerability and preliminary antitumor activity.

ClinicalTrials.gov ID: NCT05200442

A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/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: Enrolling adults with ECOG 0–1, measurable, mismatch repair–proficient/microsatellite-stable advanced/metastatic colorectal adenocarcinoma that has progressed on or is intolerant to standard metastatic CRC therapies (fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab, and anti-EGFR for RAS wild-type), excluding MSI-H/dMMR, BRAF V600, and prior regorafenib/TAS-102/fruquintinib. Patients are randomized to fruquintinib (oral selective VEGFR-1/2/3 TKI anti-angiogenic) plus TAS-102 (trifluridine/tipiracil DNA-directed cytotoxic) versus fruquintinib alone.

ClinicalTrials.gov ID: NCT06992258

Phase II Trial of 5-Fluorouracil (5FU)-Based Therapy in Combination With Fruquintinib as First Line in Patients With Locally Advanced Unresectable or 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 locally advanced unresectable or metastatic colorectal cancer (RECIST-measurable, ECOG 0–1) who have not received prior systemic therapy for advanced disease (including recurrent disease after resection without prior systemic therapy). Patients receive first-line FOLFIRI or mFOLFOX6 combined with fruquintinib, an oral selective VEGFR-1/2/3 tyrosine kinase inhibitor (anti-angiogenic) dosed days 1–21 of a 28-day cycle, with maintenance 5-FU plus fruquintinib after ~6 months in those with at least stable disease.

ClinicalTrials.gov ID: NCT07042685