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

NCT06906731 | Not Yet Recruiting Phase 1

• 1 other identifier: SHR-9803-101
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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;

Study Arms (1)

SHR-9803

EXPERIMENTAL

SHR-9803

Drug: SHR-9803

Interventions

SHR-9803 DRUG

SHR-9803

SHR-9803

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Have untreated central nervous system metastasis; or have meningeal metastasis or spinal cord compression;
• Uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites;
• Previous or co-existing malignancies；
• Severe bone damage caused by bone metastasis， including uncontrolled tumor-related pain;
• Have active or prior documented autoimmune disease;
• Have used corticosteroids (\> 10 mg/day of prednisone or equivalent) or other immunosuppressive agents for systemic treatment within 2 weeks;
• With poorly controlled or severe cardiovascular disease;
• A history of interstitial pneumonia/non-infectious pneumonia;
• Severe infection 1 month before the first dose;
• Active hepatitis B or hepatitis C, or with a history of immunodeficiency;
• 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;
• 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;
• Have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1;
• Received live-attenuated vaccines within 4 weeks prior to the first dose.
• Known to have had an allergic reaction to other monoclonal antibodies.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Harbin Medical University cancer hospital

Harbin, Heilongjiang, 150081, China

Location

Central Study Contacts

Weixia Li

CONTACT

+86 021-61053363; weixia.li@hengrui.com

Yang Wang

CONTACT

+86 021-61053363; yang.wang.yw263@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: March 26, 2025
• First Posted: April 2, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CN (1)