A Study of SHR-9803 for Injection in Patients With Advanced Solid Tumors

An Open-label, Multicenter Phase I/II Study of Safety, Tolerability,Pharmacokinetics and Efficacy of SHR-9803 for Injection in Patients With Advanced Solid Tumors

This is an open label, multi-center, multiple doses Phase I/II study to evaluate the safety, tolerability ,pharmacokinetics and efficacy of SHR-9803 for injection in subjects with advanced solid tumors.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SHR-9803

• Study Type: Interventional
• Enrollment (Estimated): 27
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Weixia Li; Phone Number: +86 021-61053363; Email: weixia.li@hengrui.com
• Study Contact Backup: Name: Yang Wang; Phone Number: +86 021-61053363; Email: yang.wang.yw263@hengrui.com

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
      • Principal Investigator: Tongsen Zheng

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. 18-75 years old, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1
4. With a life expectancy ≥ 3 months.
5. Pathologically diagnosed advanced solid tumor.
6. At least one measurable lesion according to RECIST v1.1.
7. Adequate bone marrow reserve and organ function.
8. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

Exclusion Criteria:

1. Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
2. Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
3. Previous or co-existing malignancies；
4. Severe bone damage caused by bone metastasis， including uncontrolled tumor-related pain;
5. Have active or prior documented autoimmune disease;
6. Have used corticosteroids (> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents for systemic treatment within 2 weeks;
7. With poorly controlled or severe cardiovascular disease;
8. A history of interstitial pneumonia/non-infectious pneumonia;
9. Severe infection 1 month before the first dose;
10. Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
11. With a history of inflammatory bowel disease, or those who have experienced intestinal obstruction or gastrointestinal perforation within 3 months prior to the first dose;
12. Have received more than 30 Gy of pulmonary radiation therapy within 6 months prior to the first dose; Have received major surgery，Systemic chemotherapy, endocrine therapy, monoclonal antibody therapy, macromolecular targeted therapy or other investigational products within 4 weeks; or palliative radiotherapy within 2 weeks; or oral small-molecule targeted drugs within five half-lives;
13. Have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1;
14. Received live-attenuated vaccines within 4 weeks prior to the first dose.
15. Known to have had an allergic reaction to other monoclonal antibodies.

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-9803	Drug: SHR-9803; SHR-9803

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dose Limited Toxicity（Ia）	Screening up to the end of phase Ia, an average of 6 months
Dose Limited Toxicity (Ib)	Screening up to the end of phase Ib, an average of 1 year
Recommended phase II dose(Ib)	Screening up to the end of phase Ib, an average of 2 years
objective response rate(II)	Screening up to study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse Events,	Screening up to study completion, an average of 3 year;
Disease Control Rate (DCR),	Screening up to study completion, an average of 3 year
Progression-Free Survival (PFS),	Screening up to study completion, an average of 3 year;
Plasma concentration of SHR-9803	Screening up to study completion, an average of 3 year;

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-9803-101

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