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NCT Number: NCT06895928

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

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanxi Cancer hospital

Taiyuan, Shanxi, 030001, China

Location status: Recruiting

Location contact

Jie Wang

CONTACT

[email protected]

+86-0351-4881611

Jie Wang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHR-A2102

Drug

SHR-A2102 for injection.

Bevacizumab Injection

Drug

Bevacizumab injection.

Adebelimab Injection

Drug

Adebelimab injection.

Ametinib Mesylate Tablets

Drug

Ametinib mesylate tablets.

Osimertinib Mesylate Tablets

Drug

Osimertinib mesylate tablets.

Primary outcomes

  1. Adverse events (AEs)

    Time frame: From day 1 to 90 days after the last dose.

  2. Serious adverse events (SAEs)

    Time frame: From day 1 to 90 days after the last dose.

  3. Objective response rate (ORR)

    Time frame: About 2 years.

Secondary outcomes

  1. Disease control rate (DCR)

    Time frame: About 2 years.

  2. Duration of response (DOR)

    Time frame: About 2 years.

  3. Progression free survival (PFS)

    Time frame: About 2 years.

  4. Overall survival (OS)

    Time frame: About 2 years.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Wu

CONTACT

[email protected]

+86-0518-82342973

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Mar 26, 2025
Registry last updated
Apr 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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