The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors

NCT ID: NCT05836948

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-18
• Study Completion Date: 2026-06-01

Brief Summary

This study is an open-label, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SHR-9839

three stages: dose escalation, dose expansion and efficacy expansion.

Group Type: EXPERIMENTAL

SHR-9839

Intervention Type: DRUG

Weekly fixed dose injection of SHR-9839

Interventions

SHR-9839

Weekly fixed dose injection of SHR-9839

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;

2. Have at least one measurable tumor lesion per RECIST v1.1;

3. ECOG performance status of 0-1;

4. Life expectancy ≥ 12 weeks;

5. Adequate bone marrow and organ function;

6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria

1. Patients with active central nervous system metastases or meningeal metastases;

2. Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;

3. History of serious cardiovascular and cerebrovascular diseases;

4. Subjects who received>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;

5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Hengrui Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Tumor Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rongfu Mao, MD

Role: CONTACT

rongfu.mao@hengrui.com

+86 021-61053363

Jin Wang, COD

Role: CONTACT

jin.wang@hengrui.com

+86 021-61053363

Facility Contacts

Xiangdong Cheng, Doctor

Role: primary

Chengxd516@126.cm

+86-13968032995

Other Identifiers

SHR-9839-I-101

Identifier Type: -

Identifier Source: org_study_id