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A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer

NCT07438106 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-15

No results posted yet for this study

Summary

This study will evaluate the effectiveness and safety of HRS-4642 in combination with nab-paclitaxel and gemcitabine (AG regimen) as conversion therapy for patients with locally advanced pancreatic cancer.

Participants will undergo regular assessments, including imaging scans and CA19-9 biomarker tests. If disease recurrence is suspected, unscheduled evaluations may be performed. For participants who discontinue treatment due to reasons other than disease progression (e.g., toxicity), tumor assessments will continue as scheduled until progression, loss to follow-up, death, consent withdrawal, or study termination.

After the final treatment, participants will enter a survival follow-up phase. Investigators will contact the participants or their families approximately every month (±7 days) to collect information on survival status (date and cause of death) and any subsequent anti-cancer treatments until death, loss to follow-up, study termination, or other study endpoints are met. All follow-up information will be documented in the medical records.

Conditions

  • Locally Advanced Pancreatic Cancer With KRAS G12D Mutation

Interventions

DRUG

HRS-4642 Injection

Investigational Product: HRS-4642 Injection. Dosage Form: Injection. Strength: 10 mL: 30 mg. Route of Administration: Intravenous Infusion. Manufacturer: Jiangsu Hengrui Pharmaceuticals Co., Ltd. Background: HRS-4642 is a highly potent, long-lasting, and selective KRAS G12D inhibitor developed by Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui). It is a liposomal formulation. HRS-4642 specifically binds to KRAS G12D, thereby inhibiting the phosphorylation of MEK and ERK proteins, and exerts an antitumor effect.

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-28
Primary Completion
2027-10-31
Completion
2027-12-31

Countries

  • China

Study Locations

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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 NCT07438106 on ClinicalTrials.gov