A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors

Phase 2

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: SHR-A2102; Drug: Bevacizumab Injection; Drug: Adebelimab Injection; Drug: Ametinib Mesylate Tablets; Drug: Osimertinib Mesylate Tablets

• Registration Number: NCT06895928
• Lead Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Brief Summary

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 with other antitumor therapies in advanced solid tumors to explore the reasonable dosage, safety and efficacy of SHR-A2102 for advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-26
• Study Start: 2025-03-28
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-22
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. The age of signing the informed consent is 18 -70 years, regardless of gender.
2. At least one measurable lesion according to RECIST v1.1 criteria.
3. The ECOG score is 0 or 1.
4. Expected survival ≥12 weeks.
5. Good level of organ function.
6. Have the ability to give informed consent and to comply with the treatment plan.
7. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.

Exclusion Criteria

1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases.
2. Spinal cord compression not cured by surgery and/or radiotherapy.
3. Subjects with uncontrolled tumor-related pain.
4. Received antitumor therapy within 4 weeks before the start of the study.
5. Subjects with severe cardiovascular and cerebrovascular disease.
6. History of immunodeficiency, including a positive HIV test.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	SHR-A2102	-
Treatment Group	Bevacizumab Injection	-
Treatment Group	Adebelimab Injection	-
Treatment Group	Ametinib Mesylate Tablets	-
Treatment Group	Osimertinib Mesylate Tablets	-

Primary Outcome Measures

Name	Time	Method
Adverse events (AEs)	From day 1 to 90 days after the last dose.
Serious adverse events (SAEs)	From day 1 to 90 days after the last dose.
Objective response rate (ORR)	About 2 years.

Secondary Outcome Measures

Name	Time	Method
Disease control rate (DCR)	About 2 years.
Duration of response (DOR)	About 2 years.
Progression free survival (PFS)	About 2 years.
Overall survival (OS)	About 2 years.

Trial Locations

Locations (1)

Shanxi Cancer hospital; 🇨🇳 Taiyuan, Shanxi, China