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

A Phase II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06895928

Enrollment

400

Registered

2025-03-26

Start date

2025-03-28

Completion date

2028-12-31

Last updated

2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Tumors

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.

Interventions

DRUGAdebelimab Injection

Adebelimab injection.

DRUGAmetinib Mesylate Tablets

Ametinib mesylate tablets.

DRUGOsimertinib Mesylate Tablets

Osimertinib mesylate tablets.

DRUGBevacizumab Injection

Bevacizumab injection.

DRUGSHR-A2102

SHR-A2102 for injection.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

China

Contacts

Primary ContactYang Wu

yang.wu.yw96@hengrui.com+86-0518-82342973

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026