A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A2102, Bevacizumab Injection, Adebelimab Injection, Ametinib Mesylate Tablets.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Drug SHR-A2102
SHR-A2102 for injection. - Drug Bevacizumab Injection
Bevacizumab injection. - Drug Adebelimab Injection
Adebelimab injection. - Drug Ametinib Mesylate Tablets
Ametinib mesylate tablets. - Drug Osimertinib Mesylate Tablets
Osimertinib mesylate tablets.
Primary outcome measures
- Adverse events (AEs) [Time frame: From day 1 to 90 days after the last dose.]
- Serious adverse events (SAEs) [Time frame: From day 1 to 90 days after the last dose.]
- Objective response rate (ORR) [Time frame: About 2 years.]
Secondary outcome measures (4)
- Disease control rate (DCR) [Time frame: About 2 years.]
- Duration of response (DOR) [Time frame: About 2 years.]
- Progression free survival (PFS) [Time frame: About 2 years.]
- Overall survival (OS) [Time frame: About 2 years.]
Eligibility criteria
Inclusion criteria
- The age of signing the informed consent is 18 -70 years, regardless of gender.
- At least one measurable lesion according to RECIST v1.1 criteria.
- The ECOG score is 0 or 1.
- Expected survival ≥12 weeks.
- Good level of organ function.
- Have the ability to give informed consent and to comply with the treatment plan.
- 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
- Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases.
- Spinal cord compression not cured by surgery and/or radiotherapy.
- Subjects with uncontrolled tumor-related pain.
- Received antitumor therapy within 4 weeks before the start of the study.
- Subjects with severe cardiovascular and cerebrovascular disease.
- History of immunodeficiency, including a positive HIV test.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanxi Cancer hospital — Taiyuan
Identifiers
NCT: NCT06895928 · SHR-A2102-209