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

NCT05198817 | Unknown Phase 1

• 1 other identifier: SHR-2002-I-101
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

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.

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose

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

  first dose of study medication up to 21 days

• Recommended phase II dose

  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

  first dose of study medication up to 21 days

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

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

  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 (21)

• 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

Study Arms (1)

Single Group

EXPERIMENTAL

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

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.

Single Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy;
• History of autoimmune diseases;
• History of clinically significant bleeding symptom or bleeding tendency within 3 months before the first dose of study treatment;
• History of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment;
• Evidence or history of arterial/venous thrombosis within 3 months before the first dose;

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (5)

Henan Science and Technology University First Affiliated Hospital

Luoyang, Henan, 471003, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410006, China

Location

Linyi Cancer Hospital

Linyi, Shandong, 276002, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 410013, China

Location

MeSH Terms

Interventions

Injections; SHR-1701

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: SHR-2002 injection monotherapy and in combination with other anti-cancer therapy

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 20, 2022
• Study Start: February 22, 2022
• Primary Completion: January 31, 2023
• Study Completion: June 30, 2023
• Last Updated: June 28, 2022

Record last verified: 2022-06

Locations

CN (5)