NCT06775236

Clinical Trial of SYS6010±SYH2051 Versus Chemotherapy in Advanced Breast Cancer and Other Solid Tumors

A Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of SYS6010 as a Monotherapy or in Combination With SYH2051 Compared to Investigator's Choice Chemotherapy in Patients With EGFR-Expressing Advanced Unresectable or Metastatic Solid Tumors, Including But Not Limited to Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study consists of two phases. Phase 1b and Phase 2. Phase 1b aims to evaluate the safety, tolerability, and preliminary efficacy of SYS6010 as a monotherapy and in combination with SYH2051, and to determine the recommended Phase 2 dose (RP2D) for subsequent Phase 2 studies. Phase 2 aims to assess the efficacy and safety of SYS6010 monotherapy or in combination with SYH2051 compared to investigator-selected chemotherapy in patients with EGFR-expressing, unresectable locally advanced or metastatic advanced breast cancer.

Detailed description

Phase Ⅰb Design: Group A (SYS6010 3.2 mg/kg, Q2W): Monotherapy Cohort: Planned enrollment of 8-12 breast cancer patients to evaluate the safety and preliminary efficacy of SYS6010 monotherapy. Combination Cohort: Includes dose-escalation and expansion phases. Dose-escalation phase: A "3+3" design will be used to explore the safety of SYS6010 combined with SYH2051, with SYH2051 doses ranging from 60-80 mg. Expansion phase: Upon completion of dose-escalation and confirmation of safety, breast cancer patients may be enrolled in the expansion phase. Group B (SYS6010 3.6 mg/kg, Q2W): Monotherapy Cohort: Planned enrollment of 8-12 breast cancer patients. Combination Cohort: Similar to Group A, with SYH2051 doses ranging from 40-60 mg. Group C (SYS6010 3.6 mg/kg, Q2W): Enroll 40 EGFR-expressing HR+/HER2- breast cancer patients to further evaluate the safety and efficacy in this specific population. Phase Ⅱ Design: Based on molecular subtypes of breast cancer, cohort studies will be conducted. Each cohort will enroll 125 patients, randomized in a 2:2:1 ratio into three groups: SYS6010 + SYH2051 SYS6010 monotherapy Chemotherapy control.

Conditions

• Advanced Solid Tumors
• Breast Cancer

Interventions

Type	Name	Description
DRUG	SYS6010 jnjection	SYS6010 is an antibody conjugate drug (ADC), composed of one anti-EGFR monoclonal antibody coupled to one JS1 via an enzyme specific linker
DRUG	monotherapy chemotherapy	Investigator's choice of monotherapy chemotherapy (Eribulin, Capecitabine, Gemcitabine, Vinorelbine, or Taxanes.)
DRUG	SYH2051 tablets	SYH2051 is a Selective ATM protein kinase inhibitor

Timeline

• Start date: 2025-03-20
• Primary completion: 2027-06-15
• Completion: 2028-01-15
• First posted: 2025-01-15
• Last updated: 2025-03-19