Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GDC-9545 · 1 trial · 1 indication
Laboratory parameters for hematology will be measured and compared with a standard reference range. Values outside of the standard reference range are considered abnormalities. Not every laboratory abnormality qualifies as an adverse event. A laboratory test result will be reported as an adverse event if it meets any of the following criteria: is accompanied by clinical symptoms; results in a change in study treatment, a medical intervention, or a change in concomitant therapy; or is clinically significant in the investigator's judgment.
Laboratory parameters for blood chemistry will be measured and compared with a standard reference range. Values outside of the standard reference range are considered abnormalities. Not every laboratory abnormality qualifies as an adverse event. A laboratory test result will be reported as an adverse event if it meets any of the following criteria: is accompanied by clinical symptoms; results in a change in study treatment, a medical intervention, or a change in concomitant therapy; or is clinically significant in the investigator's judgment.
Laboratory parameters for urinalysis will be measured and compared with a standard reference range. Values outside of the standard reference range are considered abnormalities. Not every laboratory abnormality qualifies as an adverse event. A laboratory test result will be reported as an adverse event if it meets any of the following criteria: is accompanied by clinical symptoms; results in a change in study treatment, a medical intervention, or a change in concomitant therapy; or is clinically significant in the investigator's judgment.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation: GDC-9545 | EXPERIMENTAL | During dose escalation, postmenopausal participants will be assigned sequentially to escalating doses of GDC-9545, up to the maximum tolerated dose (MTD) or maximum administered dose (MAD). |
| Dose Escalation: Cohort B0: GDC-9545 + Palbociclib | EXPERIMENTAL | GDC-9545 will be administered to postmenopausal participants, at a dose lower than the MTD or MAD determined in single-agent dose escalation, in combination with the label-recommended dose of palbociclib. |
| Dose Expansion: Cohort A1: GDC-9545 Dose 1 | EXPERIMENTAL | GDC-9545 will be administered to postmenopausal participants as a single-agent at a dose that is less than or equal to the MTD/MAD (Dose 1). |
| Dose Expansion: Cohort A2: GDC-9545 Dose 1 + LHRH | EXPERIMENTAL | GDC-9545 will be administered to pre- or perimenopausal participants at a dose that is less than or equal to the MTD/MAD (Dose 1) in combination with an approved LHRH agonist. |
| Dose Expansion: Cohort A3: GDC-9545 Dose 2 | EXPERIMENTAL | GDC-9545 will be administered to postmenopausal participants as a single-agent at a dose that is less than or equal to the MTD/MAD (Dose 2). |
| Dose Expansion: Cohort A4: GDC-9545 Dose 2 + LHRH | EXPERIMENTAL | GDC-9545 will be administered to pre- or perimenopausal participants at a dose that is less than or equal to the MTD/MAD (Dose 2) in combination with an LHRH agonist. |
| Dose Expansion: Cohort A5: GDC-9545 Dose 3 | EXPERIMENTAL | GDC-9545 will be administered to postmenopausal participants as a single-agent at a dose that is less than or equal to the MTD/MAD (Dose 3). |
| Dose Expansion: Cohort B1: GDC-9545 + Palbociclib | EXPERIMENTAL | GDC-9545 will be administered to postmenopausal participants, at a dose that is less than or equal to the MTD/MAD, in combination with the label-recommended dose of palbociclib. |
| Dose Expansion: Cohort B2: GDC-9545 + Palbociclib + LHRH | EXPERIMENTAL | GDC-9545 will be administered to pre- or perimenopausal participants, at a dose that is less than or equal to the MTD/MAD, in combination with the label-recommended dose of palbociclib and an approved LHRH agonist. |
| Dose Expansion: Cohort C1: GDC-9545 Dose 2 +/- Palbociclib | EXPERIMENTAL | GDC-9545 will be administered to postmenopausal participants at a pre-defined dose level (Dose 2) as a single agent for 14 days, followed by treatment with either GDC-9545 (Dose 2) plus palbociclib or GDC-9545 (Dose 2) alone for the duration of the study, as determined by the investigator. |
| Dose Expansion: Cohort C2: GDC-9545 Dose 2 + Palbociclib | EXPERIMENTAL | GDC-9545 will be administered to postmenopausal participants at a pre-defined dose level (Dose 2), in combination with the label-recommended dose of palbociclib. |
| Dose Expansion: Cohort X: GDC-9545 Dose 3 | EXPERIMENTAL | GDC-9545 will be administered at a pre-defined dose level (Dose 3) to postmenopausal participants currently receiving clinical benefit with GDC-0927 or GDC-0810 on Studies GO29656 (NCT02316509) or GO29642 (NCT01823835), respectively, upon completion of their studies. |
| Name | Type | Description |
|---|---|---|
| GDC-9545 | DRUG | GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| Palbociclib | DRUG | Palbociclib will be administered orally, once daily, at the label-recommended dose of 125 mg on Days 1-21 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. |
| LHRH Agonist | DRUG | The LHRH agonist (leuprolide acetate, goserelin acetate, or triptorelin pamoate) will be administered by injection once every 4 weeks on Day 1 of each 28-day cycle, according to the label. The investigator will choose the appropriate LHRH agonist approved for use in breast cancer. |
Inclusion Criteria for Dose Escalation: * Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent or with metastatic disease * Estrogen receptor (ER)-positi...
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GDC-9545 is an investigational small molecule being studied for the treatment of locally advanced or metastatic estrogen receptor-positive breast cancer. It is also being evaluated in healthy volunteers for pharmacokinetic studies. The drug is currently in Phase 1 clinical development.
GDC-9545 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials of the drug in multiple countries, including the United States, Australia, South Korea, Spain, and the United Kingdom.
GDC-9545 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 studying the drug alone or in combination with palbociclib and/or luteinizing hormone-releasing hormone agonist in breast cancer patients.
GDC-9545 has been studied in three Phase 1 trials. NCT03332797 is an active trial in breast cancer patients, testing the drug alone or with palbociclib and/or LHRH agonist. NCT04274075 and NCT04680273, both completed, evaluated bioavailability and drug metabolism in healthy female volunteers.
Yes, GDC-9545 has been studied in healthy female volunteers of non-childbearing potential. Two completed Phase 1 trials, NCT04274075 and NCT04680273, evaluated the drug's relative bioavailability, food effect, absorption, metabolism, and excretion in this population.