Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Immune System Diseases

Breast Neoplasms

Hypersensitivity

Breast Diseases

Skin Diseases

All Drugs and Chemicals

Hormones

Estrogens

Mitogens

Participants will take abemaciclib (150mg) orally twice a day and ZN-c5 (dose escalation) orally once or twice a day to determine the safety, tolerability, and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D).

ZN-c5

Abemaciclib (VERZENIO®) is an approved drug.

Abemaciclib

Carrie Brownstein, MD

This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) breast cancer.

All participants will receive the same treatment but ZN-c5 will be given at different doses in this dose escalation study.

A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer

A Phase 1b Study of ZN-c5 in Combination With Abemaciclib in Patients With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer

Measured by the number of treatment-emergent adverse events and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

Measured by radiographic responses as defined by revised Response Evaluation Criteria in Solid Tumor (RECIST) v1.1.

Zeno Alpha Inc.

Antineoplastic Agents

Palbociclib

Protein Kinase Inhibitors

Enzyme Inhibitors

Dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5 as well as expansion cohorts and a Phase 2 cohort.

Dose escalation cohorts are planned to determine maximum tolerated dose(MTD) or recommended phase 2 dose (RP2D) of ZN-c5 in combination with palbociclib as well as a Phase 2 cohort.

Palbociclib (IBRANCE®) is an approved drug

Zeno Alpha, Inc.

This is a Phase 1/2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. ZN-c5 will be evaluated both as monotherapy and in combination with palbociclib (IBRANCE®).

Dose escalation cohorts are planned in monotherapy and combination as well as monotherapy dose expansion, and monotherapy and combination Phase 2.

A Study of ZN-c5 in Subjects With Breast Cancer

A Phase 1/2 Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of ZN-c5 Alone and in Combination With Palbociclib in Subjects With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer

Measured by the number of treatment-emergent adverse events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of ZN-c5 and Abemaciclib in Participants With Breast Cancer	NCT04514159	Breast Cancer	ZN-c5 Abemaciclib	18 Years -	Zeno Alpha Inc.
A Study of ZN-c5 in Subjects With Breast Cancer	NCT03560531	Breast Cancer	ZN-c5 Palbociclib	18 Years -	Zeno Alpha Inc.

Spots Global Cancer Trial Database for selective estrogen receptor degrader