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Protein Degrader

H3B-6545 + Palbociclib for Breast Cancer

Phase 1
Waitlist Available
Research Sponsored by H3 Biomedicine Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ER+ HER2- locally advanced, recurrent, or metastatic breast cancer, as per local laboratory
Prior therapy in the advanced/metastatic setting
Screening 3 weeks
Treatment Varies
Follow Up from first dose of study drug up to month 24
Awards & highlights
No Placebo-Only Group

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.

Who is the study for?
This trial is for women with advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer. Participants should have had prior therapy in the advanced/metastatic setting and be in good physical condition (ECOG status of 0 or 1). They must also have proper bone marrow and organ function. Women with uncontrolled infections, recent major surgery, issues taking oral medication, substance abuse problems, or active heart disease are not eligible.Check my eligibility
What is being tested?
The study is testing the combination of two drugs: H3B-6545 and Palbociclib at various doses to find the safest and most effective dose level for women with a specific type of advanced breast cancer. The goal is to determine the maximum tolerated dose as well as a recommended dose for future Phase 2 trials.See study design
What are the potential side effects?
Potential side effects from H3B-6545 and Palbociclib may include nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver issues, hair loss among others. Side effects can vary based on individual patient factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My breast cancer is ER+ and HER2-, and it has spread or come back.
I have received treatment for cancer after it spread.
I am fully active or restricted in physically strenuous activity but can do light work.
My bone marrow and organs are working well.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first dose of study drug up to month 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug up to month 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Escalation Part: MTD and/or RP2D of Palbociclib and H3B-6545
Secondary outcome measures
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
Clinical Benefit Rate (CBR)
+13 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Palbociclib + H3B-6545 (Dose Escalation and Dose Expansion)Experimental Treatment2 Interventions
Participants will receive Palbociclib 75, 100, 125 milligram (mg) capsules or tablets, orally, once daily from Days 1 to 21 followed by 7 days off treatment in 28-day cycles along with H3B-6545 150, 300, 450 mg capsules or tablets, orally, once daily from Days 1 to 28 in 28-day cycles in dose escalation part. Based on MTD or RP2D determined for H3B-6545 in combination with palbociclib in dose escalation part, participants will continue to receive study treatment in dose expansion part until PD, development of unacceptable toxicity, or withdrawal of consent (up to 24 months).

Find a Location

Who is running the clinical trial?

H3 Biomedicine Inc.Lead Sponsor
6 Previous Clinical Trials
575 Total Patients Enrolled
Eisai Inc.Lead Sponsor
515 Previous Clinical Trials
154,822 Total Patients Enrolled

Media Library

H3B-6545 (Protein Degrader) Clinical Trial Eligibility Overview. Trial Name: NCT04288089 — Phase 1
Estrogen Receptors Research Study Groups: Palbociclib + H3B-6545 (Dose Escalation and Dose Expansion)
Estrogen Receptors Clinical Trial 2023: H3B-6545 Highlights & Side Effects. Trial Name: NCT04288089 — Phase 1
H3B-6545 (Protein Degrader) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04288089 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous health care facilities conducting this experiment?

"Currently, there are 5 clinical trial sites recruiting participants for this research study. These locations span from Kansas City to Nashville and Sarasota. To reduce travel needs, please consider selecting the closest clinic available."

Answered by AI

How many individuals is the research team recruiting for this trial?

"This investigation is no longer recruiting participants. It was first advertised on April 1st 2020, and the latest update to its status occurred on November 2nd 2022. If you are in search of other trials, there are currently 2287 clinical experiments actively enrolling patients related to estrogen receptors and 133 studies for Palbociclib (in 75 mg, 100 mg, or 125mg doses) that require volunteers."

Answered by AI

Are there still openings for participants in this experiment?

"Unfortunately, this particular study is not accepting applications at the moment. It was initially posted on April 1st 2020 and last edited November 2nd 2022. Although, there are many other clinical trials seeking candidates with receptors, estrogen and Palbociclib (75, 100 or 125 milligrams) that have open enrollment: a total of 2287 studies for the former and 133 trials for the latter."

Answered by AI

Is there any additional research into the efficacy of Palbociclib in doses of 75, 100 and 125mg?

"Palbociclib (75, 100, 125 milligram [mg]) first underwent testing at Unimed Medical Institute in 2012. Since its inception there have been 75 completed trials with an additional 133 medical studies actively recruiting participants. Much of this research is conducted from Kansas City, Missouri."

Answered by AI

What pathologies is Palbociclib (75, 100, 125 milligram [mg]) prescribed to manage?

"Palbociclib (75mg, 100mg, 125mg) is employed to treat and manage breast cancer as well as malignant neoplasms, postmenopause-associated conditions, and advance directives."

Answered by AI

Could you please elaborate on the potential threats associated with Palbociclib dosing (75, 100, 125 milligram [mg])?

"Our analysts rate the safety of Palbociclib (75, 100 and 125 milligrams) as a 1 due to its classification in Phase I clinical trials. This indicates that it has limited evidence for efficacy or safety."

Answered by AI
~7 spots leftby Feb 2025