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A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients | Clinical Trials | Clareo Health

UNKNOWNPHASE1

A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients

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

NCT05198817•Suzhou Suncadia Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study;
•2. Male or female aged ≥18 years and ≤70 years at the time of signing the ICF;
•3. Histopathologically or cytologically documented advanced or metastatic malignancies;
•4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1;
•5. Life expectancy ≥12 weeks;
•6. Adequate organ functions as defined;
•7. 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

•1. Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
•2. 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 ;
•3. Patients with tumor-related pain that cannot be controlled as determined by the investigator;
•4. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion;
•5. Systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment;
•6. Surgical procedures requiring general anesthesia within 28 days prior to the first dose of the study treatment;
•7. Patients who have received \>30 Gy of radical radiotherapy within 28 days before the first dose of study treatment;
•8. Unresolved CTCAE Grade \>1 toxicity attributed to any prior anti-tumor therapy;
•9. Use of live attenuated vaccines within 28 days before the first dose of the study treatment;
•10. Patients who have received any systemic immunosuppressants within 14 days prior to the first dose of study treatment;
+12 more criteria

Locations (5)

Henan Science and Technology University First Affiliated Hospital

Luoyang, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Linyi Cancer Hospital

Linyi, Shandong, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Key Dates

Start Date

February 22, 2022

Primary Completion Date

January 31, 2023

Completion Date

June 30, 2023

Last Updated

June 28, 2022

Enrollment

240

ESTIMATED participants

Conditions

Advanced Malignant Tumors

Interventions

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

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients

Inclusion Criteria

Exclusion Criteria

A Phase 1 Study of SSGJ-709 in Patients With Advanced Malignant Tumors

A Clinical Trial Evaluating Injection of TQB6411 in Subjects With Advanced Malignant Tumors

A Study of AK129 in Patients With Advanced Malignant Tumors

A Phase I Platform Study of Target-Based Screened CAR-Macrophages for the Treatment of Advanced Malignant Tumors

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