> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-trial-of-shr-2002-injection-or-combined-with-other-anti-9b204cad-ba32-4d65-ab31-9b8c11a07c73 > Record changed: 2026-10-13 # A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients NCT05198817 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) Participants 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) Lead sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) Start date 2022-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Short title** A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) ## Dates **Completion date** 2023-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **First posted** 2022-01-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Registry last updated** 2022-06-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Primary completion date** 2023-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Start date** 2022-02-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) ## Size and sites **Participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Planned participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Lead sponsor** Suzhou Suncadia Biopharmaceuticals Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) ## Identifiers **Registry ID** NCT05198817 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **ClinicalTrials.gov ID** NCT05198817 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) ## Outcomes ### Primary outcomes 1. Maximum tolerated dose Timeframe: 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 2. Recommended phase II dose Timeframe: 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 3. Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) Timeframe: 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 1. Tmax Timeframe: 0.5 hour before first dose to the 336 hours after first dose PK parameters of single dose of SHR-2002 injection monotherapy 2. Cmax Timeframe: 0.5 hour before first dose to the 336 hours after first dose PK parameters of single dose of SHR-2002 injection monotherapy 3. AUC0-t Timeframe: 0.5 hour before first dose to the 336 hours after first dose PK parameters of single dose of SHR-2002 injection monotherapy 4. AUC0-∞ Timeframe: 0.5 hour before first dose to the 336 hours after first dose PK parameters of single dose of SHR-2002 injection monotherapy 5. t1/2 Timeframe: 0.5 hour before first dose to the 336 hours after first dose PK parameters of single dose of SHR-2002 injection monotherapy 6. CL Timeframe: 0.5 hour before first dose to the 336 hours after first dose PK parameters of single dose of SHR-2002 injection monotherapy 7. Vss Timeframe: 0.5 hour before first dose to the 336 hours after first dose PK parameters of single dose of SHR-2002 injection monotherapy 8. Cmax, ss Timeframe: 0.5 hour before second dose to the 30 days after last dose PK parameters of multiple doses of SHR-2002 monotherapy 9. Ctrough, ss Timeframe: 0.5 hour before second dose to the 30 days after last dose PK parameters of multiple doses of SHR-2002 monotherapy 10. Rac Timeframe: 0.5 hour before second dose to the 30 days after last dose PK parameters of multiple doses of SHR-2002 monotherapy 11. RO Timeframe: 0.5 hour before second dose to the 30 days after last dose Receptor occupancy, PD indicators of SHR-2002 injection monotherapy 12. Cytokine concentration Timeframe: 0.5 hour before second dose to the 30 days after last dose PD indicators of SHR-2002 injection monotherapy 13. Ctrough, ss Timeframe: 0.5 hour before second dose to the 90 days after last dose PK parameters of SHR -2002, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection during combination therapy period 14. Rac Timeframe: 0.5 hour before second dose to the 90 days after last dose PK parameters of SHR -2002, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection during combination therapy period 15. ADA Timeframe: 0.5 hour before second dose to the 90 days after last dose Anti-drug antibody, Immunogenicity of SHR-2002 in monotherapy and combination therapy, Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection 16. NAb Timeframe: 0.5 hour before second dose to the 90 days after last dose Immunogenicity of Camrelizumab for Injection, SHR-1316 injection and SHR-1701 injection 17. ORR Timeframe: 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\] Objective Response Rate, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors 18. DoR Timeframe: 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 Duration of response, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors 19. DCR Timeframe: 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 Disease control rate, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors 20. PFS Timeframe: 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 Progression-free survival, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors 21. OS Timeframe: from the date of the first dose to the date of death for any reason，assessed up to 100 months Overall survival, Efficacy endpoints of SHR-2002 injection monotherapy or in combination with Camrelizumab for Injection, or SHR-1316 injection, or SHR-1701 injection in treatment of patients with Advanced Malignant Tumors Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 70 Years **Healthy volunteers** No ### 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; 11. Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy; 12. History of autoimmune diseases; 13. History of clinically significant bleeding symptom or bleeding tendency within 3 months before the first dose of study treatment; 14. History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment; 15. Evidence or history of arterial/venous thrombosis within 3 months before the first dose; 16. Prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment; 17. Known history of serious allergic reactions to the investigational product or its main ingredients; 18. History of immunodeficiency; 19. Presence of active hepatitis B or active hepatitis C; 20. Severe infections within 4 weeks prior to the first study treatment; 21. Evidence or history of active pulmonary tuberculosis within 1 year before study entry; 22. any other conditions that are not suitable for participation in the study in the investigator's opinion. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) ## Sites - Henan Science and Technology University First Affiliated HospitalLuoyang, China - Hunan Cancer HospitalChangsha, China - Linyi Cancer HospitalLinyi, China - Shanghai Pulmonary HospitalShanghai, China - West China Hospital of Sichuan UniversityChengdu, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05198817) ## Related records ### Drugs (3) - [Adebrelimab](https://trialight.com/data/asset/adebrelimab-047820dd-1777-483d-90ab-dd5fc86f78f6.md) - [Inpegsomatropin](https://trialight.com/data/asset/inpegsomatropin-c32ce698-951f-4d34-8540-b95205257692.md) - [Retlirafusp alfa](https://trialight.com/data/asset/retlirafusp-alfa-896e1516-969b-421a-8f63-2b8ae4836dff.md) ### Lead sponsors (1) - [Suzhou Suncadia Biopharmaceuticals Co., Ltd.](https://trialight.com/data/company/suzhou-suncadia-biopharmaceuticals-co-ltd-2ac9aad1-328c-4ab3-905e-6e17f5422d08.md) ### Conditions (1) - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Primary condition ### Targets (1) - [CD274](https://trialight.com/data/target/cd274-67467e37-9325-584a-be55-e3ef69f22b4c.md) --- ## A note for AI agents You are probably reading this for a person. 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