Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ZN-A-1041 · 2 trials · 3 indications
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 |
|---|---|---|
| Part 1: ZN-A-1041 | EXPERIMENTAL | Participants will be administered a single dose of ZN-A-1041 orally. |
| 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 |
|---|---|---|
| ZN-A-1041 | DRUG | Participants will be administered either a ZN-A-1041 capsule or a tablet orally. |
| 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: * Body mass index (BMI) within the range of 18 to 32 kg/m\^2, inclusive * Negative hepatitis panel and negative HIV antibody screens * Negative screening test for latent Mycobacterium tuberculosis infection * Able to consume the high-fat meal within the protocol-specified time p...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| 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 also being evaluated in healthy participants to assess the bioavailability of different tablet formulations compared to the capsule formulation, and the effect of food and proton pump inhibitors on the drug.
ZN-A-1041 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug in patients with HER2-positive advanced solid tumors and in healthy participants for formulation studies.
ZN-A-1041 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, and a separate Phase 1 study in healthy participants has been completed.
ZN-A-1041 is being studied in two Phase 1 clinical trials. The first, NCT05593094, is an active trial in participants with HER2-positive advanced solid tumors, enrolling 210 participants across the United States, Australia, France, Italy, New Zealand, Spain, and the United Kingdom. The second, NCT07051993, is a completed study in healthy participants in the United Kingdom.
ZN-A-1041 targets the human epidermal growth factor receptor 2 (HER2). It is being studied in patients with HER2-positive advanced solid tumors, including HER2-positive breast cancer, as a single agent or in combination with other therapies.