NCT04487236

Trial of ZN-A-1041 Enteric Capsules in Patients With HER2-Positive Advanced Solid Tumors

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ZN-A-1041 Enteric Capsules as a Single Agent or in Combination in Patients With HER2-Positive Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Suzhou Zanrong Pharma Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in patients with HER2-positive advanced solid tumors. The study will consist of three phases: phase 1a (dose escalation with ZN-A-1041 monotherapy), phase 1b (dose escalation with ZN-A-1041 in combination with Capecitabine and Trastuzumab) and phase 1c (dose expansion with ZN-A-1041 in combination with Capecitabine and Trastuzumab).

Detailed description

Phase 1a of the study will adopt the "modified 3+3" dose escalation design with a total of 7 planned dose levels. Patients with HER2-positive advanced solid tumor (including those with brain metastases) will be enrolled to receive a single-dose administration of ZN-A-1041 followed by multiple-dose administration of ZN-A-1041. Phase 1b of the study will adopt the "traditional 3+3" dose escalation design. In phase 1b, patients with HER2-positive advanced breast cancer (including those with brain metastases) will be enrolled to receive multiple doses of ZN-A-1041 in combination with Capecitabine and Trastuzumab. In phase 1c patients with HER2-positive breast cancer with brain metastases were planned to be enrolled to receive ZN-A-1041 in combination with Capecitabine and Trastuzumab The dose levels will be determined based on the recommended doses obtained from the Phase 1b study, and the possible changes in the dosage form and the food effect study, which will be decided by the sponsor and the investigator after discussion. Each phase of the study includes a screening period, a treatment period and a follow-up period. During the trial, the safety, tolerability, PK and efficacy data of ZN-A-1041 as monotherapy and in combination with Capecitabine and Trastuzumab in the subjects will be collected and analyzed, thereby providing RP2D for the subsequent clinical trials.

Conditions

• Advanced Solid Tumors
• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	ZN-A-1041 50mg BID	Orally 21days for one cycle
DRUG	ZN-A-1041 100mg BID	Orally 21days for one cycle
DRUG	ZN-A-1041 200mg BID	Orally 21days for one cycle
DRUG	ZN-A-1041 400mg BID	Orally 21days for one cycle
DRUG	ZN-A-1041 600mg BID	Orally 21days for one cycle
DRUG	ZN-A-1041 800mg BID	Orally 21days for one cycle
DRUG	ZN-A-1041 1000mg BID	Orally 21days for one cycle
DRUG	ZN-A-1041 Level 1 +Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First Cycle	ZN-A-1041 level 1 BID; Capecitabine 1000 mg/m2 BID Trastuzumab 8 mg/kg iv. First Cycle
DRUG	ZN-A-1041 Level 2 +Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First Cycle	ZN-A-1041 level 2 BID; Capecitabine 1000 mg/m2 BID Trastuzumab 8 mg/kg iv. First Cycle
DRUG	ZN-A-1041 MAD +Capecitabine 1000 mg/m2 + Trastuzumab 8 mg/kg iv. First Cycle	ZN-A-1041 MAD BID; Capecitabine 1000 mg/m2 BID Trastuzumab 8 mg/kg iv. First Cycle
DRUG	ZN-A-1041+Capecitabine + Trastuzumab 8 mg/kg iv. First Cycle	Base on 1b ZN-A-1041 dose Base on 1b Capecitabine dose Base on 1b Trastuzumab dose

Timeline

• Start date: 2020-10-15
• Primary completion: 2024-04-16
• Completion: 2025-04-16
• First posted: 2020-07-27
• Last updated: 2025-08-11

Locations

1 site across 1 country: China