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

Hengrui Medicine logo

Hengrui Medicine

Status and phase

Enrolling
Phase 2

Conditions

Advanced Solid Tumors

Treatments

Drug: Adebelimab Injection
Drug: Bevacizumab Injection
Drug: Ametinib Mesylate Tablets
Drug: Osimertinib Mesylate Tablets
Drug: SHR-A2102

Study type

Interventional

Funder types

Industry

Identifiers

NCT06895928
SHR-A2102-209

Details and patient eligibility

About

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.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

400 participants in 1 patient group

Treatment Group
Experimental group
Treatment:
Drug: SHR-A2102
Drug: Osimertinib Mesylate Tablets
Drug: Ametinib Mesylate Tablets
Drug: Bevacizumab Injection
Drug: Adebelimab Injection

Trial contacts and locations

1

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Central trial contact

Yang Wu

Data sourced from clinicaltrials.gov

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