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Also known as ZN-A-1041 Formulation 1, ZN-A-1041 Formulation 2, ZN-A-1041 Enteric Capsules, RO7771950, RG6596
ZN-A-1041 · 2 trials · 2 indications
Time from randomization to disease progression or death, according to standard criteria (Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)).
Dose at which no more than one out of six participant at the same dose level experiences a probable drug-related DLT.
Dose at which no more than one out of six participant at the same dose level experiences a probable drug-related DLT.
To evaluate the safety of ZN-A-1041 in combination with T-DM1 or with T-DXd, or in combination with PHESGO or Herceptin plus Perjeta in participants on the RP2D.
| Arm | Type | Description |
|---|---|---|
| Arm A - RO7771950 Dose Type 1 | EXPERIMENTAL | - |
| Arm B - RO7771950 Dose Type 2 | EXPERIMENTAL | - |
| Arm C - Tucatinib | ACTIVE_COMPARATOR | - |
| 1a: ZN-A-1041 | EXPERIMENTAL | Phase 1a: Participants will receive escalating doses of ZN-A-1041 orally twice a day (BID) at pre-defined dosing regimens to determine the maximum tolerated dose (MTD). |
| 1b: ZN-A-1041 + T-DM1 3.6 mg/kg iv. | EXPERIMENTAL | Phase 1b Arm1: 1. If the maximum tolerated dose (MTD) of ZN-A-1041 is identified in Phase 1a study: The 2 tentative dose levels of ZN-A-1041 are MTD-1 (Level 1) and MTD (Level 2). 2. If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level of ZN-A-1041 in Phase 1a will be used in Phase 1b study. |
| 1b: ZN-A-1041 + T-Dxd 5.4 mg/kg iv. | EXPERIMENTAL | Phase 1b Arm2: 1. If the MTD of ZN-A-1041 is identified in Phase 1a study: The 2 tentative dose levels of ZN-A-1041 are MTD-1 (Level 1) and MTD (Level 2). 2. If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level of ZN-A-1041 in Phase 1a will be used in Phase 1b study. |
| 1b: ZN-A-1041 + PHESGO / Herceptin plus Perjeta | EXPERIMENTAL | Phase 1b Arm3: 1. If the MTD of ZN-A-1041 is identified in Phase 1a study: The 2 tentative dose levels of ZN-A-1041 are MTD-1 (Level 1) and MTD (Level 2). 2. If the MTD is still not reached at the maximum dose level in Phase 1a study, the maximum dose level of ZN-A-1041 in Phase 1a will be used in Phase 1b study. |
| 1c: ZN-A-1041 + T-DM1 3.6 mg/kg iv. | EXPERIMENTAL | Phase 1c Arm1: The recommended dose combination for Phase 1c will be determined by the Investigator and the Sponsor based on the data from Phase 1b. |
| 1c: ZN-A-1041 + T-Dxd 5.4 mg/kg iv. | EXPERIMENTAL | Phase 1c Arm2: The recommended dose combination for Phase 1c will be determined by the Investigator and the Sponsor based on the data from Phase 1b. |
| 1c: ZN-A-1041 + Herceptin plus Perjeta/PHESGO | EXPERIMENTAL | Phase 1c Arm3: The recommended dose combination for Phase 1c will be determined by the Investigator and the Sponsor based on the data from Phase 1b. |
| Name | Type | Description |
|---|---|---|
| RO7771950 | DRUG | Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID). |
| Tucatinib | DRUG | Participants will receive a dose of tucatinib PO BID. |
| Trastuzumab | DRUG | Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC). |
| Capecitabine | DRUG | Participants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID. |
| ZN-A-1041 | DRUG | ZN-A-1041: escalating doses orally BID at pre-defined dosing regimens to determine the MTD |
| ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1b | DRUG | 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) |
| ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1b | DRUG | 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) |
| ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1b | DRUG | 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 |
| ZN-A-1041 + T-DM1 3.6 mg/kg iv. for Phase 1c | DRUG | 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) |
| ZN-A-1041 + T-Dxd 5.4 mg/kg iv. for Phase 1c | DRUG | 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) |
| ZN-A-1041 + PHESGO / Herceptin plus Perjeta injection for Phase 1c | DRUG | ZN-A-1041: BID via oral administration PHESGO: every 3 weeks for subcutaneous administrations (21-day cycle) Perjeta: intravenous infusion Herceptin: intravenous infusion |
Inclusion Criteria: * Pathologically documented locally advanced inoperable (LAI) or metastatic breast cancer (MBC) with confirmed HER2-positive status by central laboratory. * Measurable disease as per by RECIST v1.1 in stage 1. Non-measurable disease allowed in stage 2. * Previously treated (stab...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ZN-A-1041 is an investigational small molecule being studied for the treatment of HER2-positive advanced solid tumors, including HER2-positive breast cancer. It is being developed by Roche Holding AG and is currently in Phase 1 clinical development. It is not yet approved for any indication.
ZN-A-1041 targets human epidermal growth factor receptor 2, or HER2. It is a small molecule designed to inhibit HER2, which is overexpressed in certain advanced solid tumors, including HER2-positive breast cancer. The trial enrolls participants with HER2-positive advanced solid tumors.
ZN-A-1041 is being developed by Roche Holding AG, which trades on the OTC market under the ticker RHHBY. Roche is the sponsor of the ongoing Phase 1 clinical trial evaluating the drug in participants with HER2-positive advanced solid tumors.
ZN-A-1041 is in Phase 1 clinical development. The only trial listed is a Phase 1 study that is currently active but not recruiting. There are no completed trials, and the drug has not been approved by the FDA for any indication.
ZN-A-1041 is being evaluated in a single Phase 1 trial, NCT05593094, titled 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. The trial has an enrollment of 210 participants and is active but not recruiting.
Yes, ZN-A-1041 is also known as ZN-A-1041 Formulation 1 and ZN-A-1041 Formulation 2. These refer to different formulations of the same investigational drug. The Phase 1 trial NCT05593094 evaluates ZN-A-1041 enteric capsules, which may correspond to these formulations.