A Multicenter, Open-label Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SHR-5495 for Injection in Patients With Advanced Malignancies

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country100 target enrollmentOctober 25, 2023

ConditionsAdvanced Malignant Tumor

InterventionsSHR-5495 for injection

DrugsSHR-5495 for injection

Overview

Phase: Phase 1
Intervention: SHR-5495 for injection
Conditions: Advanced Malignant Tumor
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 100
Locations: 1
Primary Endpoint: Dose limited toxicity (DLT) of SHR-5495
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is an open, multicenter, dose-increasing/dose-expanding/efficacy expanding Phase I clinical study aimed at evaluating the tolerance, safety, PK, PD, and immunogenicity of SHR-5495 in the treatment of advanced malignant tumor patients, and preliminarily observing its anti-tumor efficacy. The entire study was divided into three stages: dose escalation, dose extension, and efficacy extension.

Registry

clinicaltrials.gov

Start Date

October 25, 2023

End Date

December 31, 2025

Last Updated

2 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

•Age range from 18 to 70 years old (including 18 and 70 years old), both male and female
•Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan
•ECOG score: 0-1
•Expected survival time ≥ 12 weeks
•Existence of measurable lesions that meet RECIST 1.1 standards
•Sufficient Hematology and end organ function shall be completed within 7 days before the first study treatment
•Left ventricular Ejection fraction (LVEF) ≥ 50% within 28 days before the first administration
•Women of childbearing age must carry out serum Pregnancy test within 7 days before the first administration, and the result is negative. Female subjects of childbearing age and male subjects with partners of childbearing age must agree to use efficient methods of contraception or abstinence within at least 26 weeks (female subjects) or 14 weeks (male subjects) from the date of signing the informed consent form until the last administration
•The patient voluntarily joined this study, signed an informed consent form, had good understand the research procedures, and have signed informed consent

Exclusion Criteria

•Has received treatment with interleukin
•Previously received immune checkpoint inhibitors
•Central nervous system metastasis with clinical symptoms in patients
•The third space effusion with clinical symptoms needs repeated drainage, such as pericardial effusion, Pleural effusion and peritoneal effusion that cannot be controlled after pumping or other treatment
•Subjects who received anti-tumor therapy and systemic immune stimulation therapy within 4 weeks prior to the first dose of the study drug; Received traditional Chinese patent medicines and simple preparations anti-tumor treatment within 2 weeks before the first dose of study drug
•Subjects who received\>30Gy of non thoracic radical radiation therapy within 28 days before the first medication, those who received\>30Gy of chest radiation therapy within 24 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 14 days before the first medication
•Subjects who have received systemic Immunosuppressive drug treatment within 2 weeks before the first administration, or who are expected to require systemic immunosuppressive drug treatment during the study treatment.
•Patients who have not recovered to ≤ CTCAE level 1 (CTCAE v5.0) due to adverse events caused by previous treatment
•Having autoimmune diseases
•Other malignant tumors within 2 years before screening, excluding fully treated cervical Carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal Carcinoma in situ after radical surgery

Arms & Interventions

SHR-5495 for injection

Intervention: SHR-5495 for injection

Outcomes

Primary Outcomes

Dose limited toxicity (DLT) of SHR-5495

Time Frame: up to 21 days

Maximum tolerated dose（MTD）of SHR-5495

Time Frame: up to 21 days

Maximum administrated dose（MAD）of SHR-5495

Time Frame: up to 21 days

AEs+SAEs

Time Frame: from the first drug administration to within 90 days for the last treatment dose

Recommended Phase II Dose (RP2D) of SHR-5495

Time Frame: up to 21 days

Secondary Outcomes

Evaluation of pharmacokinetic parameter of SHR-5495: t1/2(12 months)
Evaluation of pharmacokinetic parameter of SHR-5495: Vss(12 months)
Target cell count(12 months)
Evaluation of pharmacokinetic parameter of SHR-5495: Cmax(12 months)
Evaluation of pharmacokinetic parameter of SHR-5495: Tmax(12 months)
Evaluation of pharmacokinetic parameter of SHR-5495: AUCinf(12 months)
Receptor occupancy rate(12 months)
Overall survival (OS)(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
Evaluation of pharmacokinetic parameter of SHR-5495: AUClast(12 months)
Objective Response Rate (ORR)(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
Disease control rate (DCR)(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
Progression free survival（PFS）(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
Evaluation of pharmacokinetic parameter of SHR-5495: CL(12 months)
Duration of response (DoR)(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)