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A Phase 1 Study of Oral OP-1250 in Combination With Palbociclib in HR+/HER2- Breast Cancer Patients

O

Olema Pharmaceuticals

Status and phase

Active, not recruiting
Phase 1

Conditions

Breast Cancer

Treatments

Drug: Palazestrant
Drug: Palbociclib

Study type

Interventional

Funder types

Industry

Identifiers

NCT05266105
OP-1250-002

Details and patient eligibility

About

This is an open-label, Phase 1b dose escalation and expansion study to determine the maximum tolerated dose (MTD) of OP-1250 in combination with palbociclib (Ibrance®️, Pfizer Inc.). Purpose of study is to evaluate the safety and pharmacokinetic (PK) profile, and estimate the preliminary anti-tumor activity of the combination in adult subjects with hormone receptor-positive (ER+ / HER2-) advanced or metastatic breast cancer (MBC).

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Confirmed and evaluable locally advanced or metastatic breast cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Must not have received prior oral endocrine or targeted therapy ≤ 2 weeks prior to first dose
  • Must not have received prior chemotherapy, antibody therapy, or investigational therapy ≤ 4 weeks prior to the first dose
  • Prior radiotherapy must have been completed 2 weeks prior to first dose
  • Adequate safety laboratory tests
  • Willingness to use effective contraception

Exclusion criteria

  • Gastrointestinal disease
  • Significant hepatic disease
  • Significant cardiovascular disease
  • Significant ECG abnormalities
  • History of pulmonary embolism or high risk of thrombosis
  • Known HIV infection
  • Active infection (requiring antimicrobial therapy)
  • Pregnant

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Dose Escalation
Experimental group
Description:
This portion of the study will evaluate the safety and pharmacology of a range of OP-1250 doses administered daily with Palbociclib in subjects with advanced and/or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer
Treatment:
Drug: Palbociclib
Drug: Palazestrant
Dose Expansion
Experimental group
Description:
This portion of the study further explores the clinical activity, safety and pharmacology of OP-1250 in combination with Palbociclib and estimates preliminary data of anti-tumor efficacy
Treatment:
Drug: Palbociclib
Drug: Palazestrant

Trial contacts and locations

8

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Central trial contact

General Contact Info

Data sourced from clinicaltrials.gov

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