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

ConditionsAdvanced Solid Tumors Breast Cancer

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Age ≥ 18 years. 2. Phase 1b/Phase 2: Breast cancer (no tumor type restriction during the combination dose escalation phase).

Disqualifiers

1. Active central nervous system (CNS) metastases or carcinomatous meningitis. Patients with treated and stable brain metastases are eligible for inclusion.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

410 Participants

are divided into 3 treatment groups

Group A: SYS6010 injectionExperimental treatment 1 intervention

Group B: SYS6010 injection + SYH2051 tabletsExperimental treatment 2 interventions

Group C: Monotherapy Chemotherapy GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Dose-limiting toxicity(DLT) occurrence and incidence

The occurrence and incidence of dose-limiting toxicities (DLTs) will be assessed based on predefined criteria during the first 28 days after the initial dose. DLTs are defined as adverse events related to the study drug that meet the protocol-specified criteria for dose limitation.

Time frame

Up to approximately 3 months after the first participant is enrolled

Adverse events (AE) occurrence and incidence

The occurrence and incidence of adverse events (AEs) will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. AEs will be monitored from the first dose until the safety follow-up period.

Time frame