A Phase I/II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-1681 for Injection in Patients With Malignant Solid Tumors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.2 sites in 1 country300 target enrollmentJanuary 21, 2025

ConditionsMalignant Solid Tumors

InterventionsSHR-1681

DrugsSHR-1681

Overview

Phase: Phase 1
Intervention: SHR-1681
Conditions: Malignant Solid Tumors
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 300
Locations: 2
Primary Endpoint: Maximum tolerated dose (MTD)
Status: Recruiting
Last Updated: 3 months ago

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-1681 for injection in patients with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

January 21, 2025

End Date

July 1, 2027

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
•Subjects with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;
•Have at least one measurable tumor lesion per RECIST v1.1;
•ECOG performance score of 0-1;
•Life expectancy ≥ 3 months;
•Adequate bone marrow and organ function.

Exclusion Criteria

•Subjects with active central nervous system metastases or meningeal metastases;
•History of serious cardiovascular and cerebrovascular diseases;
•Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
•Severe infection within 4 weeks prior to the first dose;
•Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
•Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Arms & Interventions

SHR-1681

Intervention: SHR-1681

Outcomes

Primary Outcomes

Maximum tolerated dose (MTD)

Time Frame: 12 months.

Maximum administered dose (MAD)

Time Frame: 12 months.

Recommended Phase 2 dose (RP2D)

Time Frame: 12 months.

Incidence and severity of adverse events (AEs)

Time Frame: Approximately 3 years.

Incidence and severity of serious adverse events (SAEs)

Time Frame: Approximately 3 years.

Secondary Outcomes

Time to maximum concentration (Tmax) of SHR-1681(Approximately 3 years.)
Maximum concentration (Cmax) of SHR-1681(Approximately 3 years.)
Area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0-t) of SHR-1681(Approximately 3 years.)
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) of SHR-1681(Approximately 3 years.)
Anti-SHR-1681 antibody (ADA) of SHR-1681(Approximately 3 years.)
Overall response rate (ORR)(Approximately 3 years.)
Duration of response (DoR)(Approximately 3 years.)
Disease control rate (DCR)(Approximately 3 years.)
Progression-free survival (PFS)(Approximately 3 years.)
Overall survival (OS)(Approximately up to 5 years after the last subject enrolled.)