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

NCT05836948 | Recruiting Phase 1

• 1 other identifier: SHR-9839-I-101
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD) or maximum administered dose (MAD)

  Incidence and category of dose limiting toxicities (DLTs) during the first 4 week cycle of SHR-9839 treatment

  On the first day of each week,4 weeks is a treatment cycle

• Recommended Phase 2 dose (RP2D)

  RP2D will be determined on the basis of evaluation on MTD/MAD, PK, PD, efficacy data in dose escalation and dose expansion stages.

  From Day 1 to 90 days after last dose

• Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) ([CTCAE] v5.0)

  Assess safety and tolerability of SHR-9839 by way of adverse events (CTCAE v5.0).

  From Day 1 to 90 days after last dose

Secondary Outcomes (9)

• PK parameter: Tmax of SHR-9839

  approximately 10 months

• PK parameter: Cmax of SHR-9839

  approximately 10 months

• PK parameter: AUC0-t of SHR-9839

  Approximately 10 months

• PK parameter: AUC0-∞ of SHR-9839

  Approximately 10 months

• Immunogenicity of SHR-9839

  Approximately 12 months

Study Arms (1)

SHR-9839

EXPERIMENTAL

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

Drug: SHR-9839

Interventions

SHR-9839 DRUG

Weekly fixed dose injection of SHR-9839

SHR-9839

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Have at least one measurable tumor lesion per RECIST v1.1;
• ECOG performance status of 0-1;
• Life expectancy ≥ 12 weeks;
• Adequate bone marrow and organ function;
• Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

You may not qualify if:

• Patients with active central nervous system metastases or meningeal metastases;
• 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;
• History of serious cardiovascular and cerebrovascular diseases;
• 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;
• Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Zhejiang Tumor Hospital

Hangzhou, Zhejiang, 310006, China

RECRUITING

Central Study Contacts

Rongfu Mao, MD

CONTACT

+86 021-61053363; rongfu.mao@hengrui.com

Jin Wang, COD

CONTACT

+86 021-61053363; jin.wang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2023
• First Posted: May 1, 2023
• Study Start: May 18, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

CN (1)