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

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).

Conditions

• Advanced Solid Tumors
• HER2-positive Breast Cancer

Interventions

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

Sponsors & Collaborators

• Suzhou Zanrong Pharma Limited

  lead INDUSTRY

Principal Investigators

• Fei Ma, MD · Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-15

Primary Completion

2024-04-16

Completion

2025-04-16

Countries

• China

Study Locations