← Back to Search

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

Prior therapy in the advanced/metastatic setting

Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Must not have

Inability to take oral medication or presence of malabsorption

Uncontrolled significant active infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of study drug up to month 48

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I have received treatment for cancer after it spread.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My breast cancer is ER+ and HER2-, and it has spread or come back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot take pills by mouth or have a problem absorbing food.

Select...

I do not have any serious ongoing infections.

Select...

I haven't had major surgery or local treatments in the last 4 weeks.

Select...

I have heart problems or a history of heart issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of study drug up to month 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of study drug up to month 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of study drug up to month 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Tolerated Dose (MTD) of H3B-6545 and Palbociclib

Secondary study objectives

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).

0 / 7Eligibility criteria met