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 — DRUG
    Firstly 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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