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HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors

NCT ID: NCT07296341

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-12-31

Brief Summary

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This study is a randomized, open-label, multicenter Phase II clinical trial designed to evaluate the Safety, Tolerability and Preliminary Efficacy of HRS-4642 Combination with Other Antitumor Therapies in Patients with Solid Tumors

Detailed Description

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Conditions

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Locally Advanced or Metastatic Pancreatic Cancer With

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine

Group Type EXPERIMENTAL

HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine

Intervention Type DRUG

HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine

nab-paclitaxel in combination with gemcitabine

Group Type ACTIVE_COMPARATOR

HRS-4642;nab-paclitaxel; gemcitabine

Intervention Type DRUG

nab-paclitaxel in combination with gemcitabine

Interventions

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HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine

HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine

Intervention Type DRUG

HRS-4642;nab-paclitaxel; gemcitabine

nab-paclitaxel in combination with gemcitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age range of 18-75 years old (inclusive of both ends), gender not limited when signing the informed consent form
2. ECOG performance status 0 or 1
3. Life expectancy of greater than or equal to 12 weeks.
4. Subjects with unresectable local advanced or metastatic pancreatic cancer, and pancreatic duct adenocarcinoma confirmed by histopathology
5. Provide tumor tissue blocks fixed in formalin, embedded in paraffin, or unstained tumor specimen sections, which can be archived or freshly obtained within 3 years prior to the first study treatment (fresh acquisition is preferred).
6. At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)

Exclusion Criteria

1. Accompanied by untreated or active central nervous system (CNS) tumor metastasis
3. Subjects known or suspected to have interstitial pneumonia
4. According to the common adverse reaction event evaluation criteria NCI-CTCAE v5.0, patients with ≥ grade 3 serous fluid accumulation or imaging evidence of a large amount of abdominal fluid accumulation (those who require therapeutic puncture and drainage within 2 weeks before starting the study treatment, only those with imaging showing a small amount of ascites and no clinical symptoms can be enrolled)
5. Acute or chronic pancreatitis with significant clinical significance
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Zengquan Gu

Role: CONTACT

Phone: 0518-82342973

Email: [email protected]

Other Identifiers

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HRS-4642-206

Identifier Type: -

Identifier Source: org_study_id