Not yet recruiting NCT06906731
A Study of SHR-9803 for Injection in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-9803.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug SHR-9803
SHR-9803
Primary outcome measures
- Dose Limited Toxicity（Ia） [Time frame: Screening up to the end of phase Ia, an average of 6 months]
- Dose Limited Toxicity (Ib) [Time frame: Screening up to the end of phase Ib, an average of 1 year]
- Recommended phase II dose(Ib) [Time frame: Screening up to the end of phase Ib, an average of 2 years]
- objective response rate(II) [Time frame: Screening up to study completion, an average of 3 year]
Secondary outcome measures (4)
- Adverse Events, [Time frame: Screening up to study completion, an average of 3 year;]
- Disease Control Rate (DCR), [Time frame: Screening up to study completion, an average of 3 year]
- Progression-Free Survival (PFS), [Time frame: Screening up to study completion, an average of 3 year;]
- Plasma concentration of SHR-9803 [Time frame: Screening up to study completion, an average of 3 year;]
Eligibility criteria
Inclusion criteria
- Voluntary participation and written informed consent.
- 18-75 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Harbin Medical University cancer hospital — Harbin
Identifiers
NCT: NCT06906731 · SHR-9803-101