Clinical Trials for Rectal Cancer

A Dose Escalation and Dose Optimization Phase 1a/1b Study to Evaluate Safety, Tolerability and Dosimetry of Radioligand Therapy With LY4337713 in Adults With FAP-Positive Solid Tumors (FiREBOLT)

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 previously treated, locally advanced unresectable or metastatic FAP-positive solid tumors receive intravenous LY4337713, an investigational lutetium-177 radioligand that targets fibroblast activation protein on cancer-associated fibroblasts to deliver radiation to tumors. Eligible cancers include pancreatic, breast, ovarian, gastric, colorectal, esophageal, and cholangiocarcinoma.

ClinicalTrials.gov ID: NCT07213791

A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 progressing advanced or metastatic CLDN1-positive colorectal, intrahepatic cholangiocarcinoma, squamous non-small cell lung, urothelial, or cervical squamous cancers after standard systemic therapy receive intravenous ALE.P03 monotherapy. ALE.P03 is an investigational CLDN1-targeted antibody–drug conjugate that delivers exatecan, a topoisomerase I inhibitor, to CLDN1-expressing cells.

ClinicalTrials.gov ID: NCT07169734

First-in-human, Open-label, Multi-site, Phase I/IIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT329 in Participants With Advanced Solid Tumors Known to Express CA19-9

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 previously treated, advanced CA19-9–expressing solid tumors and no standard treatment option likely to benefit them receive BNT329, an investigational CA19-9–directed antibody–drug conjugate carrying a topoisomerase I inhibitor. Cohorts test different dosing schedules, one with a CA19-9–targeting antibody given before BNT329; a previously treated pancreatic cancer cohort compares two BNT329 doses.

ClinicalTrials.gov ID: NCT07186842

A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-08032562 IN PARTICIPANTS WITH ADVANCED OR METASTATIC SOLID TUMORS

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 measurable advanced or metastatic breast or colorectal cancer and ECOG 0–1 receive oral PF-08032562, an investigational KAT6A/KAT6B/KAT7 inhibitor, alone or with fulvestrant (breast cancer), cetuximab (colorectal cancer), or FOLFOX plus bevacizumab (colorectal cancer). Prior-treatment requirements vary by cohort.

ClinicalTrials.gov ID: NCT07318805

An Open-Label, Multi-Center, Dose Escalation, Confirmation, and Expansion Phase I Clinical Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of MRG007 (ARR-217) in Participants With Unresectable Locally Advanced or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 locally advanced or metastatic solid tumors who have exhausted, cannot tolerate, or lack standard treatment options receive MRG007 (ARR-217), an investigational antibody–drug conjugate targeting CDH17 and carrying the cytotoxic payload exatecan. Patients must have measurable disease, ECOG performance status 0–1, and tumor tissue available for CDH17 testing or be willing to undergo biopsy.

ClinicalTrials.gov ID: NCT07066657

A Phase 1, First-in-human (FIH), Dose-Escalation and Dose-Optimization Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: Patients with advanced or metastatic MSS/MSI-L colorectal cancer who have received at least one prior standard systemic therapy, and applicable targeted therapy for actionable alterations, receive intravenous CBI-1214. This investigational bispecific T-cell engager binds LY6G6D on tumor cells and CD3 on T cells to promote tumor killing.

ClinicalTrials.gov ID: NCT07321106

A Phase 1/2a, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of BMS-986523 As Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced Solid Malignancies

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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: For patients with unresectable locally advanced or metastatic KRAS-mutated or KRAS-amplified solid tumors who have received, are ineligible for, or decline standard care, this study evaluates BMS-986523 alone or with pembrolizumab, cetuximab, or gemcitabine plus nab-paclitaxel. BMS-986523 is an investigational protein-degradation therapy with an undisclosed target; the pembrolizumab arm additionally requires PD-L1 expression ≥50%.

ClinicalTrials.gov ID: NCT07223047

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of JMT108 Injection in Participants With Advanced Malignant Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 or metastatic solid tumors who lack effective standard treatment receive intravenous JMT108, initially every 2 weeks, in dose-escalation and tumor-specific expansion cohorts. JMT108 is an investigational PD-1–targeted antibody–IL-15 fusion protein designed to block PD-1 and deliver IL-15 signaling preferentially to PD-1–positive immune cells.

ClinicalTrials.gov ID: NCT07317505

A Phase 1, Open-label Dose Escalation and Expansion Study OF PT0511 in Participants With KRAS Mutated OR Amplified Advanced Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 or metastatic solid tumors harboring any KRAS mutation or wild-type KRAS amplification receive intravenous PT0511, an investigational pan-KRAS protein degrader. A colorectal cancer expansion cohort receives PT0511 plus cetuximab, an anti-EGFR antibody.

ClinicalTrials.gov ID: NCT07300150

A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

No known activity

No investigational drug(s) in this trial have shown anticancer activity yet 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 progressing relapsed or refractory, locally advanced inoperable or metastatic CRPC, colorectal, lung, head and neck, gynecologic, triple-negative breast, or esophageal squamous cell cancer receive 177Lu-BetaBart in a single-arm dose-escalation and expansion study. This investigational lutetium-177–labeled antibody targets B7-H3 (CD276) to deliver radiation to tumors.

ClinicalTrials.gov ID: NCT07189871