A Phase 1 Trial of ZN-A-1041 Enteric Capsules or Combination in Participants With Human Epidermal Growth Factor Receptor 2 (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 participants with HER2-positive advanced solid tumors with or without brain metastases.

The study will consist of three phases: Phase 1a (dose escalation with ZN-A-1041 monotherapy), Phase 1b (dose escalation with ZN-A-1041 combination therapy) and Phase 1c (dose expansion with ZN-A-1041 combination therapy).

Conditions

• Advanced Solid Tumors
• HER2-positive Breast Cancer

Interventions

DRUG

ZN-A-1041

ZN-A-1041: escalating doses orally BID at pre-defined dosing regimens to determine the MTD

DRUG

ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b

ZN-A-1041: BID via oral administration T-DM1: 3.6 mg/kg given as an intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)

DRUG

ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b

ZN-A-1041: BID via oral administration T-DXd: 5.4 mg/kg given as an intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)

DRUG

ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b

ZN-A-1041: BID via oral administration PHESGO dose is 600 mg pertuzumab/600 mg trastuzumab/2000 unites hyaluronidase every 3 weeks for subcutaneous administrations (21-day cycle) Perjeta is 420 mg administered as an intravenous infusion Herceptin is 6 mg/kg administered as an intravenous infusion

DRUG

ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c

ZN-A-1041: BID via oral administration T-DM1: intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)

DRUG

ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1c

ZN-A-1041: BID via oral administration T-DXd: intravenous infusion on the first day of each treatment cycle, once every 3 weeks (21-day cycle)

DRUG

ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1c

ZN-A-1041: BID via oral administration PHESGO: every 3 weeks for subcutaneous administrations (21-day cycle) Perjeta: intravenous infusion Herceptin: intravenous infusion

Sponsors & Collaborators

• Hoffmann-La Roche

  lead INDUSTRY

Principal Investigators

• Clinical Trials · Hoffmann-La Roche

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-03

Primary Completion

2027-07-31

Completion

2027-07-31

FDA Drug

Yes

Countries

• United States
• Australia
• France
• Italy
• New Zealand
• Spain
• United Kingdom

Study Locations