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

NCT07736612 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Zhejiang University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2028-08-30
Completion
2029-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07736612 on ClinicalTrials.gov