Clinical Trials for Rectal Cancer

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

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 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

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/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

Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen

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 or locally advanced/inoperable GI cancers (colorectal and non-colorectal; ECOG 0–1; excluding dMMR/MSI-H, known DPD deficiency, and prior oxaliplatin/fluoropyrimidine) receive an oxaliplatin/leucovorin backbone with infusional 5-FU, using an adaptive algorithm to escalate 5-FU from 2,400 to up to 3,200 mg/m2 over early cycles based on tolerance. Investigational aspect is individualized 5-FU dose escalation within a FOLFOX-like regimen to optimize dose intensity and assess response, PFS, and PK correlations.

ClinicalTrials.gov ID: NCT05780684

Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors

Low burden on patient

The trial has a low burden on patients. An example would be a trial testing an oral drug, with scans every 12 weeks which would be similar to standard of care.

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 solid tumors (e.g., NSCLC, melanoma, RCC, urothelial, HNSCC, MSI-H/dMMR cancers, TNBC, HCC, gastric/GEJ, cervical, anal, Merkel cell) who have at least stable disease after ~12 months of PD-1/PD-L1 therapy (pembrolizumab, nivolumab, atezolizumab, durvalumab, or avelumab) are randomized to discontinue therapy versus continue until progression. Compares de-escalation after 1 year to ongoing checkpoint blockade to evaluate disease control, time to next treatment, and safety.

ClinicalTrials.gov ID: NCT04157985

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.

HealthScout 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

An Open Label Phase II Study for the Treatment of Liver Metastatic Colorectal Cancer and Non-Small Cell Lung Cancer With a Combination of TATE (Trans-Arterial Tirapazamine Embolization) and Pembrolizumab

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.

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 evaluates the combination of Trans-Arterial Tirapazamine Embolization (TATE) and Pembrolizumab in patients with metastatic colorectal cancer (mCRC) and non-small cell lung cancer (NSCLC) who have liver metastases and have progressed after prior therapies. TATE delivers the hypoxia-activated prodrug Tirapazamine to liver tumors, while Pembrolizumab, an immune checkpoint inhibitor, blocks the PD-1 pathway to enhance anti-tumor immunity.

ClinicalTrials.gov ID: NCT04701476

An Open-label Phase 1/2 Dose Finding, Safety and Efficacy Study of Oral NEO212 in Patients with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Uncontrolled Brain Metastasis in Patients with Select Solid Tumors.

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: This clinical trial evaluates the safety and efficacy of the investigational drug NEO212, a novel conjugate of temozolomide and perillyl alcohol with enhanced brain penetration, in adults with Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, or uncontrolled brain metastases from select solid tumors, including combinations with standard treatments like pembrolizumab or ipilimumab.

ClinicalTrials.gov ID: NCT06047379

A Phase 1/2 Study to Assess the Safety and Antitumor Activity of APL-5125 in Adults With Selected Advanced Solid Tumors

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.

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet in clinical trials

HealthScout AI summary: Eligible patients are adults with select advanced or metastatic solid tumors (including colorectal, cholangiocarcinoma, appendiceal, pancreatic, gastric, endometrial, triple negative breast, ovarian, or prostate cancers) who have exhausted standard therapies; phase 2 focuses on colorectal cancer. Therapy is with APL-5125, an oral CK2α kinase inhibitor targeting Wnt signaling.

ClinicalTrials.gov ID: NCT06399757

Phase 1b, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study of RMC-6291 in Combination with RMC-6236 in Participants with Advanced KRAS G12C Mutant Solid Tumors

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 advanced or metastatic solid tumors harboring KRAS G12C mutations (including pretreated NSCLC and other solid tumors), who receive a combination of the investigational KRAS G12C inhibitors RMC-6291 and RMC-6236. Both agents specifically inhibit KRAS G12C mutant protein to suppress tumor growth, and eligibility includes both KRAS G12C inhibitor–naïve and previously treated patients, excluding those with primary CNS tumors or active brain metastases.

ClinicalTrials.gov ID: NCT06128551