Study Summary
This trial is testing a combination of two drugs to treat estrogen receptor-positive breast cancer. The goal is to find the maximum tolerated dose and/or the recommended Phase 2 dose of the combination.
Eligible Conditions
- Estrogen Receptors
- Breast Cancer
- HER2-positive Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 21 Secondary · Reporting Duration: From first dose of study drug up to Month 24
Day 28
Ratio of PK AUC24 Parameter Estimates Between Day 21 (H3B-6545) and Day 28 (H3B-6545)
Ratio of PK C24 Parameter Estimates Between Day 21 (H3B-6545) and Day 28 (H3B-6545)
Ratio of PK Cmax Parameter Estimates Between Day 21 (H3B-6545) and Day 28 (H3B-6545)
Day 28
Ratio of PK AUC24 Parameter Estimates Between Day 21 (Palbociclib) and Day 8 (Palbociclib)
Ratio of PK C24 Parameter Estimates Between Day 21 (Palbociclib) and Day 8 (Palbociclib)
Ratio of Pharmacokinetic (PK) Cmax Parameter Estimates Between Day 21 (Palbociclib) and Day 8 (Palbociclib)
Day 28
AUC(0-t): Area Under the Plasma Concentration-time Curve from Time 0 to the Last Measurable Point for Palbociclib and H3B-6545
C24: Plasma Concentration at 24 hour Post-dose for Palbociclib and H3B-6545
Cmax: Maximum Observed Plasma Concentration for Palbociclib and H3B-6545
Ratio of PK AUC24 Parameter Estimates Between Day 21 (H3B-6545) and Day 28 (H3b-6545)
Ratio of PK C24 Parameter Estimates Between Day 21 (H3B-6545) and Day 28 (H3b-6545)
Ratio of PK Cmax Parameter Estimates Between Day 21 (H3B-6545) and Day 28 (H3b-6545)
Ratio of PK Cmax Parameter Estimates Between Day 21 (Palbociclib) and Day 8 (Palbociclib)
Tmax: Time to Reach the Cmax for Palbociclib and H3B-6545
Day 28
Dose Escalation Part: MTD and/or RP2D of Palbociclib and H3B-6545
Month 24
Progression-free Survival (PFS)
Month 24
Disease Control Rate (DCR)
Objective Response Rate (ORR)
Month 24
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Month 24
Duration of Response (DoR)
Month 24
Overall Survival (OS)
Month 24
Clinical Benefit Rate (CBR)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Palbociclib + H3B-6545 (Dose Escalation and Dose Expansion)
1 of 1
Experimental Treatment
36 Total Participants · 1 Treatment Group
Primary Treatment: Palbociclib (75, 100, 125 milligram [mg]) · No Placebo Group · Phase 1
Palbociclib + H3B-6545 (Dose Escalation and Dose Expansion)Experimental Group · 2 Interventions: Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (150, 300, 450 mg) · Intervention Types: Drug, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from first dose of study drug up to month 24
Who is running the clinical trial?
H3 Biomedicine Inc.Lead Sponsor
6 Previous Clinical Trials
520 Total Patients Enrolled
Eisai Inc.Lead Sponsor
506 Previous Clinical Trials
145,023 Total Patients Enrolled
Eligibility Criteria
Age 18+ · Female Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have locally advanced, recurrent, or metastatic breast cancer, as per local laboratory.
You have a performance status of 0 or 1.
References
- Furman, Craig, Xiaoling Puyang, Zhaojie Zhang, Zhenhua J. Wu, Deepti Banka, Kiran B. Aithal, Lee A. Albacker, et al.. 2022. “Covalent Erα Antagonist H3B-6545 Demonstrates Encouraging Preclinical Activity in Therapy-resistant Breast Cancer”. Molecular Cancer Therapeutics. American Association for Cancer Research (AACR). doi:10.1158/1535-7163.mct-21-0378.
- Furman C, Puyang X, Zhang Z, Wu ZJ, Banka D, Aithal KB, Albacker LA, Hao MH, Irwin S, Kim A, Montesion M, Moriarty AD, Murugesan K, Nguyen TV, Rimkunas V, Sahmoud T, Wick MJ, Yao S, Zhang X, Zeng H, Vaillancourt FH, Bolduc DM, Larsen N, Zheng GZ, Prajapati S, Zhu P, Korpal M. Covalent ERalpha Antagonist H3B-6545 Demonstrates Encouraging Preclinical Activity in Therapy-Resistant Breast Cancer. Mol Cancer Ther. 2022 Jun 1;21(6):890-902. doi: 10.1158/1535-7163.MCT-21-0378.
- 2020. "A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04288089.
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Conditions
Cancer Related
Treatments