Your session is about to expire
← 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
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 belowSelect...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose (MTD) of H3B-6545 and Palbociclib
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 moreTrial 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
502 Total Patients Enrolled
1 Trials studying Breast Cancer
206 Patients Enrolled for Breast Cancer
Eisai Inc.Lead Sponsor
517 Previous Clinical Trials
158,901 Total Patients Enrolled
17 Trials studying Breast Cancer
2,044 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently using alcohol or drugs in a harmful way.My bone marrow and organs are working well.I have received treatment for cancer after it spread.I cannot take pills by mouth or have a problem absorbing food.I am fully active or restricted in physically strenuous activity but can do light work.I do not have any serious ongoing infections.I haven't had major surgery or local treatments in the last 4 weeks.My breast cancer is ER+ and HER2-, and it has spread or come back.I have heart problems or a history of heart issues.
Research Study Groups:
This trial has the following groups:- Group 1: Palbociclib + H3B-6545 (Dose Escalation and Dose Expansion)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger