A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Study ID
- NCT05198817
- Phase
- PHASE1
- Status
- Unknown
Conditions
- Advanced Malignant Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection — DRUGFirstly Dose Escalation and Dose Expansion of SHR-2002 injection monotherapy should be conducted. After RP2D and MTD of the SHR-2002 injection monotherapy were confirmed, Dose Escalation, Dose Expansion and Efficacy Expansion of SHR-2002 injection in combination with other anti-cancer treatment would be completed, including Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection.
Study Details
The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-2002 injection monotherapy and in combination with other anti-cancer therapy for advanced malignant tumors of patients. To explore the reasonable dosage of SHR-2002 injection monotherapy and dosage regimen of combination therapy for advanced malignant tumors of patients.
Key Dates
- Start date
- Feb 22, 2022
- Status verified
- Jun 2022
- Primary completion
- Jan 31, 2023
- Completion
- Jun 30, 2023
Study Design
- Enrollment
- 240 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Single Group
Primary Outcome Measure
Maximum tolerated dose [ Time Frame: first dose of study medication up to 21 days ]
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