Clinical trial NCT05198817: A Trial of SHR-2002 Injection or Combined With Other Anti-cancer Medication in Advanced Malignant Tumors of Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Malignant Tumors
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-20
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SHR-2002 injection monotherapy and in combination with other anti-cancer therapy
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: first dose of study medication up to 21 days
measure: Recommended phase II dose
timeFrame: first dose of study medication up to 21 days
measure: 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
Secondary outcomes:
measure: Tmax
timeFrame: 0.5 hour before first dose to the 336 hours after first dose
measure: Cmax
timeFrame: 0.5 hour before first dose to the 336 hours after first dose
measure: AUC0-t
timeFrame: 0.5 hour before first dose to the 336 hours after first dose
measure: AUC0-∞
timeFrame: 0.5 hour before first dose to the 336 hours after first dose
measure: t1/2
timeFrame: 0.5 hour before first dose to the 336 hours after first dose
measure: CL
timeFrame: 0.5 hour before first dose to the 336 hours after first dose
measure: Vss
timeFrame: 0.5 hour before first dose to the 336 hours after first dose
measure: Cmax, ss
timeFrame: 0.5 hour before second dose to the 30 days after last dose
measure: Ctrough, ss
timeFrame: 0.5 hour before second dose to the 30 days after last dose
measure: Rac
timeFrame: 0.5 hour before second dose to the 30 days after last dose
measure: RO
timeFrame: 0.5 hour before second dose to the 30 days after last dose
measure: Cytokine concentration
timeFrame: 0.5 hour before second dose to the 30 days after last dose
measure: Ctrough, ss
timeFrame: 0.5 hour before second dose to the 90 days after last dose
measure: Rac
timeFrame: 0.5 hour before second dose to the 90 days after last dose
measure: ADA
timeFrame: 0.5 hour before second dose to the 90 days after last dose
measure: NAb
timeFrame: 0.5 hour before second dose to the 90 days after last dose
measure: 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]
measure: 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
measure: 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
measure: 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
measure: OS
timeFrame: from the date of the first dose to the date of death for any reason，assessed up to 100 months
Other outcomes:
Locations:
city: Luoyang
country: China
facility: Henan Science and Technology University First Affiliated Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
Study officials:
References: