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A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
Phase 1
Waitlist Available
Research Sponsored by InventisBio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called D-0502 alone and with another drug, palbociclib, in women with a specific type of advanced breast cancer. The goal is to see if these drugs are safe and effective by blocking signals that help cancer cells grow.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: D-0502 in combination with palbociclibExperimental Treatment2 Interventions
D-0502 in combination with palbociclib
Group II: D-0502Experimental Treatment1 Intervention
D-0502
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
palbociclib
2020
Completed Phase 2
~1230
D-0502
2018
Completed Phase 1
~240
Find a Location
Who is running the clinical trial?
InventisBio Inc.Lead Sponsor
7 Previous Clinical Trials
699 Total Patients Enrolled
1 Trials studying Breast Cancer
14 Patients Enrolled for Breast Cancer
InventisBio Co., LtdLead Sponsor
19 Previous Clinical Trials
1,638 Total Patients Enrolled
1 Trials studying Breast Cancer
14 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You haven't received any cancer treatment in the last 30 days before starting the study.There may be additional criteria set by the study that you need to meet or avoid.You have brain tumors that are getting worse or causing symptoms, and they haven't been treated yet.You have only received a small number of treatments in the past for your advanced or metastatic disease, including chemotherapy, hormone therapy, or targeted therapy.
Research Study Groups:
This trial has the following groups:- Group 1: D-0502
- Group 2: D-0502 in combination with palbociclib
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.