Clinical Trials for Rectal Cancer

A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants 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.

TrialFetch AI summary: Adults with unresectable, advanced/metastatic gastric/GEJ/esophageal adenocarcinoma (HER2‑negative, MSS/pMMR) in the 2L setting and ESCC in 1L or 2L receive the anti‑CCR8 monoclonal antibody CHS‑114 (depletes intratumoral CCR8+ Tregs via enhanced ADCC/ADCP) plus the PD‑1 inhibitor toripalimab, with cisplatin/5‑FU added in 1L ESCC. Requires measurable disease and tissue; excludes active CNS metastases and prior anti‑CCR8.

ClinicalTrials.gov ID: NCT06657144

A Phase 1b/2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of GSK5764227 Alone and in Combination in Participants With Previously Treated Advanced Unresectable or Metastatic Gastrointestinal 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.

TrialFetch AI summary: Adults with unresectable or metastatic colorectal cancer (after 1–2 prior lines) or pancreatic ductal adenocarcinoma (after exactly 1 prior line), ECOG 0–1, receive monotherapy GSK5764227 (HS-20093), a B7-H3–targeted antibody-drug conjugate delivering a topoisomerase I inhibitor, at cohort-specific dose levels. Excludes active CNS mets, significant cardiovascular/hepatic/renal disease, prior topo‑I ADCs, and viral hepatitis; tumor tissue required for CRC and requested for PDAC.

ClinicalTrials.gov ID: NCT06885034

A Phase 1b/2 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants 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.

TrialFetch AI summary: Enrolls adults (ECOG 0–1) with unresectable/metastatic colorectal adenocarcinoma or metastatic castration-resistant prostate cancer. Tests the B7-H3–targeted antibody-drug conjugate GSK5764227 (anti–B7-H3 mAb linked to a topoisomerase inhibitor payload) in combination with bevacizumab ± 5-FU/leucovorin for metastatic CRC, or with enzalutamide for mCRPC.

ClinicalTrials.gov ID: NCT07277270

A Phase 1b/2 Study of Combination Immunotherapy for the Treatment of Chemotherapy-refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer (CRC)

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.

TrialFetch AI summary: Adults with chemotherapy-refractory metastatic microsatellite-stable/pMMR colorectal adenocarcinoma (ECOG 0–1) with measurable disease after fluoropyrimidine-, oxaliplatin-, and irinotecan-based therapy (prior anti-VEGF/anti-EGFR allowed) and at least one lesion amenable to core biopsy. Treatment is nadunolimab (CAN04), an anti–IL-1RAP monoclonal antibody blocking IL-1α/IL-1β signaling and promoting ADCC, plus toripalimab (anti–PD-1) IV every 3 weeks for up to 12 months or until progression.

ClinicalTrials.gov ID: NCT07281716

A Phase 1/2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JAB-23E73 in Adult Patients With Advanced Solid Tumors With KRAS Alteration

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.

TrialFetch AI summary: Enrolls adults with locally advanced/metastatic, measurable KRAS-altered solid tumors (ECOG 0–1) not amenable to curative therapy, including expansion cohorts for colorectal cancer, pancreatic ductal adenocarcinoma, and other KRAS-altered tumors; prior KRAS G12C/G12D/pan-KRAS inhibitor exposure is not allowed. Treatment is oral single-agent JAB-23E73, a small-molecule pan-KRAS inhibitor designed to inhibit KRAS across ON and OFF states (with downstream MAPK suppression), with dose escalation/optimization followed by fixed-dose expansion.

ClinicalTrials.gov ID: NCT06973564

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) Inhibitors in Combination With Ivonescimab With or Without Other Anti-Cancer Agents in Patients 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.

TrialFetch AI summary: Adults with locally advanced/metastatic solid tumors harboring KRAS/NRAS/HRAS mutations (ECOG 0–1, measurable disease) who have progressed on/intolerant to standard therapy are eligible for dose exploration, with expansions in previously untreated non-squamous NSCLC without another actionable driver and in solid tumors/CRC with ≤2 prior advanced lines (HNSCC excluded). Patients receive an oral RAS(ON) inhibitor—daraxonrasib (pan-RAS(ON)), elironrasib (KRAS G12C(ON)), or zoldonrasib (KRAS G12D(ON))—combined with ivonescimab (PD-1/VEGF bispecific antibody), with select cohorts adding platinum/pemetrexed chemotherapy, cetuximab, or additional RAS(ON) inhibitor.

ClinicalTrials.gov ID: NCT07397338

Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant 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.

TrialFetch AI summary: Eligible patients are adults with locally advanced/metastatic KRAS G12V–mutant solid tumors (ECOG 0–1, measurable disease) that have progressed on or are intolerant to standard therapies. Treatment is oral RMC-5127, a KRAS G12V–selective RAS(ON) inhibitor (cyclophilin A–enabled tri-complex), given alone or combined with oral daraxonrasib (pan-RAS(ON) inhibitor) or with cetuximab.

ClinicalTrials.gov ID: NCT07349537

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

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: 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

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: 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

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: 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