Clinical trial NCT06906731: A Study of SHR-9803 for Injection in Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-04-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Dose Limited Toxicity（Ia）
timeFrame: Screening up to the end of phase Ia, an average of 6 months
measure: Dose Limited Toxicity (Ib)
timeFrame: Screening up to the end of phase Ib, an average of 1 year
measure: Recommended phase II dose(Ib)
timeFrame: Screening up to the end of phase Ib, an average of 2 years
measure: objective response rate(II)
timeFrame: Screening up to study completion, an average of 3 year
Secondary outcomes:
measure: Adverse Events,
timeFrame: Screening up to study completion, an average of 3 year;
measure: Disease Control Rate (DCR),
timeFrame: Screening up to study completion, an average of 3 year
measure: Progression-Free Survival (PFS),
timeFrame: Screening up to study completion, an average of 3 year;
measure: Plasma concentration of SHR-9803
timeFrame: Screening up to study completion, an average of 3 year;
Other outcomes:
Locations:
city: Harbin
country: China
facility: Harbin Medical University cancer hospital
state: Heilongjiang
Study officials:
References: