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NOT YET RECRUITING
NCT07736612
PHASE1/PHASE2

A Pan-RAS Inhibitor in Combination With Anti-Tumor Therapy in Participants With Advanced Pancreatic Cancer

Sponsor: Zhejiang University

View on ClinicalTrials.gov

Summary

This study aims to evaluate the safety, tolerability, and efficacy of HRS-2329 in combination with other anti-tumor therapies in participants with advanced pancreatic cancer harboring RAS mutations or amplifications.

Official title: A Phase Ib/II Study of the Safety, Tolerability, and Efficacy of a Pan-RAS Inhibitor in Combination With Anti-Tumor Therapy in Participants With Advanced Pancreatic Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-08-15

Completion Date

2029-12-30

Last Updated

2026-07-30

Healthy Volunteers

No

Interventions

DRUG

HRS-2329 Tablet

HRS-2329 is a novel, potent, oral pan-RAS inhibitor that demonstrates strong inhibitory activity against a broad range of RAS-related targets, including KRAS G12V, KRAS G12C, KRAS G12D, KRAS wild-type, NRAS, and HRAS. HRS-2329 forms a ternary complex with Cyclophilin A (CypA) and the target, thereby blocking the binding of RAS-GTP to downstream proteins and disrupting downstream signaling pathways. This ultimately inhibits tumor cell proliferation and exerts anti-tumor effects. HRS-2329 240 mg is given orally (to be swallowed whole, not chewed) once daily on a 3-week cycle. It should be taken orally within 30 minutes after breakfast each morning.

DRUG

Nimotuzumab

Nimotuzumab is a marketed drug, a recombinant humanized monoclonal antibody targeting the epidermal growth factor receptor (EGFR). Nimotuzumab is administered at 400 mg by intravenous infusion over at least 60 minutes on Days 1 and 8 of each 3-week cycle.

DRUG

HS-20093

HS-20093 is a B7-H3 antibody-drug conjugate (ADC) composed of the HS-20093 naked antibody (HS-20093 Ab) and a small-molecule toxin (HS-9265, also known as SHR169265) conjugated via a cleavable tetrapeptide linker. The anti-B7-H3 antibody is a humanized immunoglobulin G1 (IgG1) monoclonal antibody (mAb), and the small-molecule toxin, an exatecan derivative, is a topoisomerase I inhibitor. HS-20093 injection is administered at 8.0 mg/kg by intravenous infusion on Day 1 of each 3-week cycle.

DRUG

Adebrelimab

Adebrelimab is a recombinant humanized anti-PD-L1 monoclonal antibody injection. It specifically blocks the binding of PD-1 to PD-L1, thereby terminating the immunosuppressive signals transmitted through PD-1 to T cells. This enables T cells to re-recognize tumor cells and exert cytotoxic effects, ultimately inhibiting tumor growth. Adebrelimab injection is administered at 1200 mg by intravenous infusion on Day 1 of each 3-week cycle.

Locations (1)

the First Affiliated Hospital, School of Medicine

Hangzhou, Zhejiang, China