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

NCT06895928 | Recruiting Phase 2

• 1 other identifier: SHR-A2102-209
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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.

Study Arms (1)

Treatment Group

EXPERIMENTAL

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

Interventions

SHR-A2102 DRUG

SHR-A2102 for injection.

Treatment Group

Bevacizumab Injection DRUG

Bevacizumab injection.

Treatment Group

Adebelimab Injection DRUG

Adebelimab injection.

Treatment Group

Ametinib Mesylate Tablets DRUG

Ametinib mesylate tablets.

Treatment Group

Osimertinib Mesylate Tablets DRUG

Osimertinib mesylate tablets.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanxi Cancer hospital

Taiyuan, Shanxi, 030001, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab; osimertinib

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yang Wu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 26, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 22, 2025

Record last verified: 2025-03

Locations

CN (1)