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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SHR-A2102; Drug: Bevacizumab Injection; Drug: Adebelimab Injection; Drug: Ametinib Mesylate Tablets; Drug: Osimertinib Mesylate Tablets

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yang Wu; Phone Number: +86-0518-82342973; Email: yang.wu.yw96@hengrui.com

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Recruiting
      • Shanxi Cancer Hospital
      • Principal Investigator: Jie Wang
      • Contact: Jie Wang; Phone Number: +86-0351-4881611; Email: zlhuxi@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 26, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Antineoplastic Agents, Immunological; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Osimertinib; Bevacizumab
• Other Study ID Numbers: SHR-A2102-209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No