A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-A2009 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.0 sites270 target enrollmentOctober 2023

ConditionsAdvanced Solid Tumors

InterventionsSHR-A2009 for injection ； Almonertinib Mesilate Tablets SHR-A2009 for injection；Adebrelimab Injection

DrugsSHR-A2009 for injection ； Almonertinib Mesilate Tablets SHR-A2009 for injection；Adebrelimab Injection

Overview

Phase: Phase 1
Intervention: SHR-A2009 for injection ； Almonertinib Mesilate Tablets
Conditions: Advanced Solid Tumors
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 270
Primary Endpoint: Objective Response Rate (ORR) (phase II).
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies in patients with advanced solid tumors.

Registry

clinicaltrials.gov

Start Date

October 2023

End Date

December 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 to 75 years old (inclusive), Female or male
•Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology
•Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting;
•At least one measurable tumor lesion according to RECIST v1.1 (enrollment of subjects with only non-target lesions is permitted in Stage IB phase)
•ECOG performance score of 0-1;
•Expected survival time ≥ 12 weeks;
•Adequate bone marrow and organ function
•Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.

Exclusion Criteria

•Subjects with active central nervous system (CNS) metastases.
•Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled.
•Subjects with uncontrolled tumor-related pain
•Clinically uncontrollable third space fluid
•Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug;
•Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
•Major organ surgery or significant trauma within 4 weeks prior to first use of study drug;
•Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
•Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function
•Serious cardiovascular disease

Arms & Interventions

Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets

Intervention: SHR-A2009 for injection ； Almonertinib Mesilate Tablets

Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection

Intervention: SHR-A2009 for injection；Adebrelimab Injection

Outcomes

Primary Outcomes

Objective Response Rate (ORR) (phase II).

Time Frame: 2 years

Incidence of dose-limiting toxicity (DLT) (phase IB)

Time Frame: 21 days after the first dose was administered to each subject.

Secondary Outcomes

PK parameter: toxin-binding antibody of SHR-A2009(through study completion, an average of 2 years)
PK parameter: free toxin of SHR-A2009(through study completion, an average of 2 years)
Plasma concentration of Adebrelimab(through study completion, an average of 2 years)
Duration of response(DoR )(One year after the last subject was enrolled in the group)
Progression Free Survival(PFS)(2 years after the last subject was enrolled in the group)
Objective response rate(2 years after the last subject was enrolled in the group)
overall survival (OS) (phase IB)(3 years after the last subject was enrolled in the group)
Incidence of AEs（Phase II (efficacy expansion phase)）(from Day1 to 90 days after last dose)
Incidence of SAEs（Phase II (efficacy expansion phase)）(from Day1 to 90 days after last dose)
PK parameter: total antibody of SHR-A2009(through study completion, an average of 2 years)
Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB)(through study completion, an average of 2 years)