Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ZN-A-1041, RG6596
RO7771950 · 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...
RO7771950 is being developed for the treatment of HER2-positive breast cancer, specifically locally advanced or metastatic disease. It is an investigational small molecule from Roche Holding AG and is being studied in patients whose tumors are human epidermal growth factor receptor 2 (HER2)-positive.
RO7771950 is being developed by Roche Holding AG, which trades over the counter in the United States under the ticker RHHBY. Roche is the sponsor of the clinical program evaluating the compound in HER2-positive breast cancer.
RO7771950 is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 2 study is currently recruiting participants and is designed to enroll approximately 650 patients with locally advanced or metastatic HER2-positive breast cancer.
RO7771950 is being evaluated in the Phase 2 trial NCT07413939, which compares RO7771950 with tucatinib, both in combination with trastuzumab and capecitabine, in people with locally advanced or metastatic HER2-positive breast cancer. The trial is recruiting, is randomized, uses an active control, and is open to participants aged 18 years and older across sites in North America, South America, Europe, Asia, Australia, and Africa.
The Phase 2 trial NCT07413939 is a randomized, active-controlled study comparing RO7771950 against tucatinib, each given with trastuzumab and capecitabine, in patients with locally advanced or metastatic HER2-positive breast cancer. It is recruiting approximately 650 participants aged 18 years and older, with enrollment open to all sexes and no healthy volunteers.