A Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SHR-2002 Injection or in Combination With Other Anti-cancer Therapy in Advanced Malignant Tumors of Patients

Suzhou Suncadia Biopharmaceuticals Co., Ltd.5 sites in 1 country240 target enrollmentFebruary 22, 2022

ConditionsAdvanced Malignant Tumors

InterventionsSHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection

DrugsSHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection

Overview

Phase: Phase 1
Intervention: SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection
Conditions: Advanced Malignant Tumors
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 240
Locations: 5
Primary Endpoint: Maximum tolerated dose
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 22, 2022

End Date

June 30, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
•Male or female aged ≥18 years and ≤70 years at the time of signing the ICF;
•Histopathologically or cytologically documented advanced or metastatic malignancies;
•An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
•Life expectancy ≥12 weeks;
•Adequate organ functions as defined;
•Female and male patients of reproductive potential must agree to use highly effective contraception during the study treatment period and within 6 months after the last investigational drug administration; Female of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days before the first dose of the investigational drugs and must not be breastfeeding.

Exclusion Criteria

•Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
•Patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
•Patients with tumor-related pain that cannot be controlled as determined by the investigator;
•Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
•Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment;
•Surgical procedures requiring general anesthesia within 28 days prior to the first dose of the study treatment;
•Patients who have received \>30 Gy of radical radiotherapy within 28 days before the first dose of study treatment;
•Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy;
•Use of live attenuated vaccines within 28 days before the first dose of the study treatment;
•Patients who have received any systemic immunosuppressants within 14 days prior to the first dose of study treatment;

Arms & Interventions

Single Group

Intervention: SHR-2002 injection、Camrelizumab for Injection, SHR-1316 injection, SHR-1701 injection

Outcomes

Primary Outcomes

Maximum tolerated dose

Time Frame: first dose of study medication up to 21 days

The Maximum tolerated dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection

Recommended phase II dose

Time Frame: first dose of study medication up to 21 days

The Recommended phase II dose of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection

Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)

Time Frame: from signature completion of ICF to 90 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks

Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Secondary Outcomes

Cytokine concentration(0.5 hour before second dose to the 30 days after last dose)
Tmax(0.5 hour before first dose to the 336 hours after first dose)
Cmax(0.5 hour before first dose to the 336 hours after first dose)
AUC0-t(0.5 hour before first dose to the 336 hours after first dose)
AUC0-∞(0.5 hour before first dose to the 336 hours after first dose)
t1/2(0.5 hour before first dose to the 336 hours after first dose)
CL(0.5 hour before first dose to the 336 hours after first dose)
Vss(0.5 hour before first dose to the 336 hours after first dose)
Cmax, ss(0.5 hour before second dose to the 30 days after last dose)
Ctrough, ss(0.5 hour before second dose to the 90 days after last dose)
Rac(0.5 hour before second dose to the 90 days after last dose)
RO(0.5 hour before second dose to the 30 days after last dose)
ADA(0.5 hour before second dose to the 90 days after last dose)
NAb(0.5 hour before second dose to the 90 days after last dose)
ORR(from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months])
DCR(from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, assessed up to 6 months)
PFS(from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, assessed up to 6 months)
DoR(from the date of the firstly documented tumor response to the date of the firstly documented disease progression or the date of death for any reason, assessed up to 6 months)
OS(from the date of the first dose to the date of death for any reason，assessed up to 100 months)