Clinical Trials for Rectal Cancer

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.

HealthScout 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.

HealthScout 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

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.

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.

HealthScout 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

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.

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.

HealthScout 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

An Open-label Randomized Phase 3 Study of Tucatinib in Combination With Trastuzumab and mFOLFOX6 Versus mFOLFOX6 Given With or Without Either Cetuximab or Bevacizumab as First-line Treatment for Subjects With HER2+ 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.

HealthScout AI summary: This trial enrolls adults with previously untreated, HER2-positive, RAS wild-type metastatic colorectal cancer to compare standard first-line mFOLFOX6-based regimens versus mFOLFOX6 combined with trastuzumab and tucatinib, a selective oral HER2 tyrosine kinase inhibitor. Eligible patients may have stable, treated brain metastases.

ClinicalTrials.gov ID: NCT05253651

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

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.

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.

HealthScout 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

A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours

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.

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.

HealthScout AI summary: Adults with metastatic or unresectable gastrointestinal cancers (including mCRC, gastric/GEJ, pancreatic, cholangiocarcinoma) eligible for FOLFOX, generally after at least one prior line; current randomized expansion focuses on second-line mCRC that is oxaliplatin-naïve, BRAF WT, MSI-stable, and not receiving biologics. Investigational agent BOLD-100, a ruthenium-based compound that inhibits GRP78/BiP to disrupt ER stress and induce apoptosis, is combined with standard FOLFOX.

ClinicalTrials.gov ID: NCT04421820

A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)

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.

HealthScout AI summary: Adults with metastatic colorectal adenocarcinoma who progressed after first-line FOLFOX plus bevacizumab (ECOG 0–2), excluding MSI‑H and BRAF V600–mutant tumors, receive fruquintinib (oral VEGFR‑1/2/3 inhibitor) added to standard FOLFIRI as second-line therapy. Single-arm design; treatment continues until progression or intolerance.

ClinicalTrials.gov ID: NCT07011576

(ID-COMET) A Randomized Phase III Trial of Immediate Versus Six-Month Delayed Comprehensive Treatment of 1-10 Oligometastatic Tumors With or Without Synchronous Primary

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.

HealthScout AI summary: Adults and children (ECOG 0–3) with newly diagnosed oligometastatic lung, colorectal, or prostate cancer (1–10 lesions; brain mets excluded) are randomized to immediate stereotactic ablative radiotherapy (SABR) to all treatable sites plus standard systemic therapy versus initial standard therapy with SABR delayed ~6 months; a separate cohort allows immediate SABR for broader oligometastatic/oligoprogressive disease. Compares survival/ADT-free survival and safety/quality of life while standard systemic regimens are given per tumor type.

ClinicalTrials.gov ID: NCT06563388

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

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.

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.

HealthScout AI summary: Adults with metastatic uveal melanoma or other solid tumors harboring GNAQ/GNA11 mutations or PRKC fusions (ECOG 0–1) receive the oral pan–PKC inhibitor darovasertib (IDE196) as monotherapy or combined with binimetinib (MEK inhibitor) or crizotinib (MET/ALK/ROS1 inhibitor). Key exclusions include prior PKC inhibitor use and, for crizotinib cohorts, prior ALK/MET/ROS1 inhibitors and ILD/pneumonitis; HLA-A*02:01–positive uveal melanoma patients should have considered tebentafusp first line.

ClinicalTrials.gov ID: NCT03947385