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Clinical Trials for Rectal Cancer

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There are 194 active trials for advanced/metastatic rectal cancer.

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194 trials meet filter criteria.

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No known activity More information High burden on patient More information
Sponsor: Pfizer (industry) Phase: 1 Start date: Dec. 16, 2025

TrialFetch AI summary: Adults with measurable advanced/metastatic breast cancer (progressed after ≥1 line endocrine therapy and a CDK4/6 inhibitor) or advanced/metastatic colorectal cancer (previously treated per standard options, plus one cohort without prior chemo for metastatic disease), ECOG 0–1. Participants receive oral investigational agent PF-08032562 (target/mechanism not publicly described) as monotherapy or combined with fulvestrant (breast) or cetuximab or FOLFOX + bevacizumab (colorectal) in 28-day cycles with dose escalation/expansion.

ClinicalTrials.gov ID: NCT07318805

No known activity More information High burden on patient More information
Sponsor: Sutro Biopharma, Inc. (industry) Phase: 1 Start date: Nov. 7, 2025

TrialFetch AI summary: Adults (ECOG 0–1) with refractory/recurrent locally advanced or metastatic solid tumors—particularly tissue factor–expressing cancers such as HNSCC, NSCLC, esophagogastric, colorectal, pancreatic ductal adenocarcinoma, cervical, endometrial, or urothelial carcinoma—after appropriate prior systemic therapy (prior-line limits vary by study part) are eligible. Treatment is STRO-004, a tissue factor–targeting antibody–drug conjugate delivering an exatecan (topoisomerase I inhibitor) payload, given as monotherapy with dose escalation/expansion or combined with pembrolizumab (PD-1 inhibitor).

ClinicalTrials.gov ID: NCT07227168

No known activity More information High burden on patient More information
Sponsor: Lepu Biopharma Co., Ltd. (industry) Phase: 1 Start date: July 25, 2025

TrialFetch AI summary: Enrolling adults with unresectable locally advanced or metastatic solid tumors (often GI) that have progressed on or lack standard options, ECOG 0–1, with measurable disease and available tissue/biopsy for CDH17 testing. Patients receive open-label MRG007 (ARR-217), a CDH17-targeted antibody–drug conjugate delivering an exatecan-based topoisomerase I inhibitor payload, in dose escalation followed by confirmation/expansion.

ClinicalTrials.gov ID: NCT07066657

No known activity More information High burden on patient More information
Sponsor: Cartography Biosciences (industry) Phase: 1 Start date: Jan. 6, 2026

TrialFetch AI summary: Adults with advanced/metastatic MSS or MSI-low colorectal cancer previously treated with at least one standard systemic regimen (and, if applicable, progressed on appropriate FDA-approved targeted therapy for actionable alterations) receive IV CBI-1214, a bispecific T-cell engager that binds LY6G6D on tumor cells and CD3 on T cells to redirect cytotoxicity. Dose escalation with subsequent expansion at the selected dose evaluates safety/tolerability, PK, and preliminary anti-tumor activity.

ClinicalTrials.gov ID: NCT07321106

No known activity More information High burden on patient More information
Sponsor: Sairopa B.V. (industry) Phase: 1 Start date: April 3, 2023

TrialFetch AI summary: Enrolling adults (ECOG 0–1) with metastatic/unresectable solid tumors refractory to standard therapy (excluding melanoma, primary brain tumors/GBM, sarcoma, and pancreatic ductal adenocarcinoma; no active untreated brain mets), with expansion cohorts limited to ≤3 prior systemic lines and focused on PD-(L)1–naïve MSS colorectal cancer without liver metastases and PD-1 relapsed/refractory MSS endometrial cancer, RCC, or NSCLC. Patients receive IV ADU-1805 (anti-SIRPα mAb blocking the SIRPα–CD47 “don’t eat me” checkpoint to enhance myeloid/macrophage activity) every 3 weeks alone or with fixed-dose pembrolizumab every 3 weeks.

ClinicalTrials.gov ID: NCT05856981

No known activity More information High burden on patient More information
Sponsor: Bristol-Myers Squibb (industry) Phase: 1/2 Start date: Nov. 25, 2025

TrialFetch AI summary: Adults with locally advanced unresectable or metastatic solid tumors harboring a KRAS alteration (mutation or amplification) who have progressed on, are ineligible for, or declined standard-of-care therapy (Arm D additionally requires PD-L1 TPS ≥50%; excludes untreated CNS metastases and ILD/pneumonitis). Participants receive the first-in-human agent BMS-986523 (target/mechanism not publicly described) as monotherapy or combined with pembrolizumab (anti–PD-1), cetuximab (anti-EGFR), or gemcitabine plus nab-paclitaxel.

ClinicalTrials.gov ID: NCT07223047

No known activity More information High burden on patient More information
Sponsor: Conjupro Biotherapeutics, Inc. (industry) Phase: 1 Start date: Dec. 2, 2025

TrialFetch AI summary: Adults (≥18) with locally advanced or metastatic solid tumors that are refractory/intolerant to standard therapies or lack standard options (ECOG 0–2; no active CNS/leptomeningeal metastases) receive IV JMT108 every 2 weeks (with possible alternate schedules in expansion). JMT108 is a fully human anti–PD-1 antibody fused to IL-15 intended to combine checkpoint blockade with IL-15–driven activation/proliferation of CD8+ T cells and NK cells, with tumor-specific expansion cohorts including lung, colorectal, hepatocellular, gastric cancers, melanoma, and other solid tumors.

ClinicalTrials.gov ID: NCT07317505

No known activity More information High burden on patient More information
Sponsor: PAQ Therapeutics, Inc. (industry) Phase: 1 Start date: Nov. 21, 2025

TrialFetch AI summary: Adults with locally advanced/metastatic measurable solid tumors harboring any KRAS mutation or wild-type KRAS amplification (ECOG 0–1) after 1–4 prior systemic regimens are treated with IV PT0511 monotherapy in dose-escalation/expansion cohorts; a colorectal cancer expansion cohort receives PT0511 plus cetuximab (anti-EGFR). PT0511 is an investigational KRAS-altered tumor–directed agent, but its specific molecular mechanism/allele selectivity is not publicly specified.

ClinicalTrials.gov ID: NCT07300150

No known activity More information High burden on patient More information
Sponsor: Radiopharm Theranostics, Ltd (industry) Phase: 1/2 Start date: Sept. 24, 2025

TrialFetch AI summary: Enrolls adults with relapsed/refractory, locally advanced inoperable, or metastatic solid tumors (including CRPC, NSCLC/SCLC, CRC, HNSCC, ovarian/cervical/endometrial cancers, TNBC, and esophageal SCC) who have progressed after their most recent therapy and have no suitable standard option, with ECOG 0–2 and adequate organ function (measurable disease required except in CRPC; prior Lu-177–PSMA excluded for CRPC). Patients receive 177Lu-BetaBart, a lutetium-177–labeled anti–B7-H3 (CD276) monoclonal antibody delivering beta-particle radiation as systemic radioimmunotherapy in a dose-escalation/expansion design.

ClinicalTrials.gov ID: NCT07189871

No known activity More information High burden on patient More information
Sponsor: GlaxoSmithKline (industry) Phase: 1/2 Start date: Oct. 20, 2025

TrialFetch AI summary: Adults with advanced unresectable/metastatic/recurrent dMMR/MSI-H solid tumors (ECOG 0–2) who have exhausted standard options, with expansion limited to measurable colorectal or endometrial cancer after 1–3 prior systemic lines including at least one immune checkpoint inhibitor. Treatment is oral GSK5460025 monotherapy, a first-in-human nucleotide excision repair–dependent DNA-damaging agent being developed for dMMR/MSI-H tumors.

ClinicalTrials.gov ID: NCT07213609

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