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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

NCT03471663 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-01-08

No results posted yet for this study

Summary

This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.

Conditions

Interventions

DRUG

D-0502

oral tablets

DRUG

palbociclib

standard dose of palbociclib

Sponsors & Collaborators

  • InventisBio Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-18
Primary Completion
2023-10-18
Completion
2023-10-18
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03471663 on ClinicalTrials.gov