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

An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-9839 for Injection in Patients With Advanced Solid Tumors

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: SHR-9839

• Study Type: Interventional
• Enrollment (Estimated): 174
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rongfu Mao, MD; Phone Number: +86 021-61053363; Email: rongfu.mao@hengrui.com
• Study Contact Backup: Name: Jin Wang, COD; Phone Number: +86 021-61053363; Email: jin.wang@hengrui.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Zhejiang Tumor Hospital
      • Contact: Xiangdong Cheng, Doctor; Phone Number: +86-13968032995; Email: Chengxd516@126.cm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SHR-9839; three stages: dose escalation, dose expansion and efficacy expansion.	Drug: SHR-9839; Weekly fixed dose injection of SHR-9839

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameter: Tmax of SHR-9839	Time to maximum concentration of SHR-9839	approximately 10 months
PK parameter: Cmax of SHR-9839	Maximum concentration of SHR-9839	approximately 10 months
PK parameter: AUC0-t of SHR-9839	Area under the concentration-time curve from time 0 to the last measurable concentration time point of SHR-9839	Approximately 10 months
PK parameter: AUC0-∞ of SHR-9839	Area under the concentration-time curve from time 0 to infinity of SHR-9839	Approximately 10 months
Immunogenicity of SHR-9839	Anti-SHR-9839 antibody (ADA)	Approximately 12 months
Overall response rate (ORR)	Evaluated using RECIST 1.1	Approximately within 36 months
Duration of response (DoR)	Evaluated using RECIST 1.1	Approximately within 36 months
Disease control rate (DCR)	Evaluated using RECIST 1.1	Approximately within 36 months
Progression-free survival (PFS)	Evaluated using RECIST 1.1	Approximately within 36 months

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-9839-I-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No