A Phase I/II Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-3276 Injection in Patients With Advanced Malignant Tumors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country115 target enrollmentDecember 10, 2024

ConditionsAdvanced Solid Tumors

InterventionsSHR-3276

Overview

Phase: Phase 1
Intervention: SHR-3276
Conditions: Advanced Solid Tumors
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 115
Locations: 1
Primary Endpoint: Incidence and severity of adverse events
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in patients with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

December 10, 2024

End Date

December 30, 2028

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able and willing to sign a written informed consent；
•Age 18-70 years old (including both ends), both male and female；
•Pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan；
•Existence of measurable lesions；
•ECOG score: 0-1；
•Expected survival time ≥ 12 weeks；
•The functional level of the major organs must meet the requirements；
•Fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; And must be non-lactating.

Exclusion Criteria

•Central nervous system metastasis or meningeal metastasis with clinical symptoms;
•Spinal cord compression that has not been treated radically by surgery and/or radiotherapy；
•Patients with uncontrolled tumor-related pain as judged by the investigator
•A third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator；
•Systemic antitumor therapy was administered within 28 days prior to treatment in the first study；
•Surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, or elective surgery was expected during the trial period；
•Serious drug-related adverse reactions during previous immune checkpoint inhibitor therapy；
•Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1；
•Live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment；
•Systemic immunosuppressive therapy was administered within 14 days prior to the first study

Arms & Interventions

SHR-3276 for Injection will be administrated per dose level in which the patients are assigned.

Intervention: SHR-3276

Outcomes

Primary Outcomes

Incidence and severity of adverse events

Time Frame: up to 3 years

MTD

Time Frame: up to 6 months

RP2D

Time Frame: up to 1 year

Secondary Outcomes

Receptor Occupancy（OR） of SHR-3276(up to 3 years)
Anti-drug antibody (ADA) of SHR-3276(up to 3 years)
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, up to 3 years)
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, up to 3 years)
Time to maximum concentration (Tmax)(up to 3 years)
Maximum concentration (Cmax)(up to 3 years)
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, up to 3 years)
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, up to 3 years)
Overall survival (OS)(From date of administration until the date of first documented progression or date of death from any cause, whichever came first, up to 3 years)