Clinical Trials for Rectal Cancer

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

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 unresectable/metastatic solid tumors lacking effective options receive TU2218 (oral dual ALK5/TGFBR1 and VEGFR2 inhibitor targeting TGF-β/VEGF-mediated immunosuppression) plus pembrolizumab; expansion cohorts include PD-(L)1–naïve or post-platinum HNSCC (PD-L1 CPS ≥1 for naïve), biliary tract cancer after standard therapy, and PD-(L)1–naïve pMMR/MSS colorectal cancer after ≥2 lines (excluding CRC with liver metastases). Suitable for ECOG 0–1; key exclusions include active CNS disease, significant cardiovascular disease, active autoimmune disease requiring systemic therapy, prior TGF-β inhibitors, prior PD-(L)1 in specified cohorts, and certain drug–drug interactions.

ClinicalTrials.gov ID: NCT05784688

A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers

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.

HealthScout AI summary: Adults with unresectable/metastatic GI cancers—previously treated colorectal or pancreatic ductal adenocarcinoma, and biliary tract cancers (treatment‑naive or previously treated)—receive sacituzumab tirumotecan (MK‑2870), a TROP2‑targeted antibody–drug conjugate delivering a belotecan‑derived topoisomerase I inhibitor, as monotherapy or combined with 5‑FU/leucovorin, or with cisplatin plus pembrolizumab. Excludes significant ophthalmologic disease and prior steroid‑requiring ILD/pneumonitis; prior therapy toxicities must have resolved.

ClinicalTrials.gov ID: NCT06428409

A Phase 1, Open Label, Dose Escalation of HBI-2438 in Patients With Advanced Malignant Solid Tumors Harboring KRAS G12C Mutation

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: The trial is recruiting adult patients with advanced malignant solid tumors harboring KRAS G12C mutations who have exhausted standard therapies, aiming to evaluate the safety and maximum tolerated dose of HBI-2438, an investigational oral small molecule that irreversibly targets and inactivates KRAS G12C.

ClinicalTrials.gov ID: NCT05485974

A Phase 1 Study of the Safety and Efficacy of CRX100 as Monotherapy and in Combination With Pembrolizumab in Advanced Solid Malignancies

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 targets adult patients with advanced solid malignancies and evaluates the safety and efficacy of CRX100, an investigational immunotherapy combining autologous T cells and oncolytic vaccinia virus, as monotherapy and in combination with Pembrolizumab.

ClinicalTrials.gov ID: NCT04282044

A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

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: The trial involves adult patients with advanced solid tumors harboring specific RAS mutations, including KRAS G12, who have progressed after standard therapies, evaluating the safety and tolerability of RMC-6236, an oral selective inhibitor targeting active RAS(ON) with a novel 'tri-complex' mechanism. This investigational drug shows promising early efficacy, especially in KRAS G12X-related pancreatic and non-small cell lung cancers.

ClinicalTrials.gov ID: NCT05379985

A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination With Anticancer Agents in Participants With Selected 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: This trial investigates GSK4381562, a monoclonal antibody targeting PVRIG to enhance NK and T cell activation, as monotherapy and in combination with anticancer agents such as dostarlimab, belrestotug, nelistotug, and GSK5764227 in patients with advanced solid tumors who lack standard treatment options. Eligible participants have locally recurrent or metastatic solid tumors, have progressed after standard therapies, and possess an ECOG performance status of 0-1 with adequate organ function.

ClinicalTrials.gov ID: NCT05277051

A Phase 1, Open-Label, Dose Escalation of HBI-2376 in Patients With Advanced Malignant Solid Tumors Harboring KRAS or EGFR Mutations

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 focuses on patients with advanced solid tumors carrying KRAS or EGFR mutations who have relapsed or are refractory to standard treatments, using the oral SHP2 inhibitor HBI-2376 to target pathways involved in cancer cell survival and proliferation.

ClinicalTrials.gov ID: NCT05163028

A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-022, an Anti-TIM-3 Monoclonal Antibody, in Patients With Advanced Solid Tumors (AMBER)

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 investigates TSR-022, a TIM-3 checkpoint inhibitor, as monotherapy or in combination with therapies such as anti-PD-1 drugs in adult patients with advanced or metastatic solid tumors, including NSCLC and HCC, who have previously been treated with standard therapies. Eligible patients should have measurable disease and agree to biopsies for TIM-3 expression assessment.

ClinicalTrials.gov ID: NCT02817633

A Phase 1/2 Study of LY3537982 in Patients With KRAS G12C-Mutant 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: This trial enrolls adults with advanced solid tumors harboring a KRAS G12C mutation, including both previously treated and some untreated NSCLC and CRC patients, to evaluate the oral KRAS G12C inhibitor LY3537982 (olomorasib) as monotherapy or in combination with pembrolizumab, cetuximab, pemetrexed, cisplatin, or carboplatin.

ClinicalTrials.gov ID: NCT04956640

Single Arm Study to Assess the Immune Effects of Fermented Wheat Germ (FWG) Nutritional Supplementation in Patients With Advanced Malignancies Being Treated With Standard of Care Checkpoint Inhibitor-Based 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 advanced non-small cell lung, renal cell, melanoma, colorectal, or triple-negative breast cancers eligible for standard checkpoint inhibitor immunotherapy will receive oral fermented wheat germ supplementation (a nutritional product with proposed but unproven immunomodulatory effects) alongside their standard immunotherapy regimen. No chemotherapy, radiotherapy, or recent immunomodulatory agents are allowed prior to enrollment.

ClinicalTrials.gov ID: NCT05967533