Clinical Trials for Rectal Cancer

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.

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

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.

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

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.

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

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.

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

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.

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

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.

HealthScout 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.

HealthScout AI summary: Adults with EGFR‑dependent advanced solid tumors—primarily mCRC (RAS/RAF WT, MSS; anti‑EGFR–naive for chemo combos or 3L+ without HER2 amp/oncogenic EGFR ECD mutations) and previously included HNSCC—receive petosemtamab, a bispecific anti‑EGFR/LGR5 IgG1 antibody given Q2W as monotherapy or combined with FOLFOX/FOLFIRI (and previously pembrolizumab in HNSCC). Suitable for ECOG 0–1 patients without uncontrolled CNS disease; aims to exploit EGFR blockade and LGR5‑targeted EGFR degradation with Fc effector function.

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.

HealthScout AI summary: Adults with advanced/metastatic solid tumors, including biomarker-selected cohorts (e.g., ATM loss/alterations; platinum‑resistant high‑grade serous ovarian cancer; selected endometrial, colorectal, and pancreatic cancers), after appropriate standard therapies. Investigational therapy is ART0380, an oral ATR kinase inhibitor exploiting replication-stress/synthetic lethality, given as monotherapy or combined with gemcitabine or irinotecan; includes a randomized cohort of platinum‑resistant ovarian cancer comparing ART0380+gemcitabine versus gemcitabine.

ClinicalTrials.gov ID: NCT04657068