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Trial record 3 of 3 for:    olema

Phase 1b Combo w/ Ribociclib and Alpelisib

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05508906
Recruitment Status : Recruiting
First Posted : August 19, 2022
Last Update Posted : September 26, 2022
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Olema Pharmaceuticals, Inc.

Brief Summary:

This is a Phase 1b open-label, 2-part study in 2 treatment groups. The 2 treatment groups are as follows:

Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).

Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation).


Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Advanced Breast Cancer HR-positive Breast Cancer HER2-negative Breast Cancer Drug: OP-1250 Drug: Ribociclib Drug: Alpelisib Phase 1

Detailed Description:

Part 1 (Dose Escalation): This part will evaluate the safety and pharmacokinetics (PK) of a range of doses of OP-1250 administered orally (PO) every day (QD) to subjects in combination with either 600 mg of ribociclib administered PO QD (Treatment Group 1) or with 300 mg of alpelisib administered PO QD (Treatment Group 2) to determine the recommended phase 2 dose (RP2D). The dose escalation phase will evaluate 3 to 6 subjects per cohort who are sequentially enrolled and monitored for DLTs during the first cycle of study treatment. Each cohort will be reviewed for safety, PK, and dose-limiting toxicity DLTs. The DLT observation may be extended to 2 cycles.

Part 2 (Dose Expansion): This part of the study will further evaluate the safety and PK of OP-1250 at the RP2D in combination with either ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2) and provide an exploratory estimate of anti-tumor activity of the combinations.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Treatment Group 1: OP-1250 in combination with ribociclib

Treatment Group 2: OP-1250 in combination with alpelisib

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b Open-Label Multicenter Study of OP-1250 in Combination With the CDK4/6 Inhibitor Ribociclib or With the PI3K Inhibitor Alpelisib in Adult Subjects With Advanced and/or Metastatic HR Positive, HER2 Negative Breast Cancer
Actual Study Start Date : August 31, 2022
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ribociclib

Arm Intervention/treatment
Experimental: OP-1250 with Ribociclib
Treatment Group 1: OP-1250 in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
Drug: OP-1250
OP-1250 is a small molecule and a CERAN being developed for the treatment of patients with advanced or metastatic HR+ and HER2- breast cancer.

Drug: Ribociclib
All subjects in Treatment Group 1 will receive OP-1250 in combination with ribociclib.
Other Name: KISQALI

Experimental: OP-1250 with Alpelisib
Treatment Group 2: OP-1250 in combination with alpelisib (PIQRAY®, Novartis Pharmaceuticals Corporation)
Drug: OP-1250
OP-1250 is a small molecule and a CERAN being developed for the treatment of patients with advanced or metastatic HR+ and HER2- breast cancer.

Drug: Alpelisib
All subjects in Treatment Group 2 will receive OP-1250 in combination with alpelisib.
Other Name: PIQRAY




Primary Outcome Measures :
  1. Identify DLT, MTD, and RP2D of OP-1250 [ Time Frame: Completion of Dose Escalation to 1 cycle 28 days ]
    To identify the maximum tolerated dose (MTD), and/or RP2D of OP-1250 when administered in combination with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2).

  2. Assess the safety and tolerability [ Time Frame: Completion of Dose Expansion up to 1 year ]
    To further characterize the safety and tolerability of OP-1250 at the RP2D when administered in combination with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2).


Secondary Outcome Measures :
  1. Assess the anti-tumor activity using RECIST [ Time Frame: Completion of Dose Escalation up to 1 cycle 28 days ]
    To preliminarily assess the anti-tumor activity (ORR, defined as confirmed complete response [CR] + confirmed partial response [PR]) of OP-1250 when administered in combination with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2), as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).

  2. Assess the anti-tumor activity using RECIST [ Time Frame: Completion of Dose Expansion up to 1 year ]
    To preliminarily assess the anti-tumor activity (ORR, defined as confirmed complete response [CR] + confirmed partial response [PR]) of OP-1250 when administered in combination with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2), as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female or male aged >18 years.
  • Willing and able to participate and comply with all study requirements
  • Histologically- or cytologically-confirmed advanced or MBC
  • HR+/HER2- disease, as determined in the most recently obtained archival tumor tissue sample from a metastatic site, using locally accepted criteria by the local pathology report
  • Evaluable disease (measurable and non-measurable): Measurable disease, ie, at least 1 measurable lesion as per RECIST 1.1 (a lesion at a previously irradiated site may only be counted as a target lesion if there is clear sign of progression since the irradiation).-Subject must have received at least 6 months of a prior continuous endocrine therapy for locally advanced or metastatic breast cancer
  • Life expectancy ≥6 months, as judged by the investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  • Has received no more than 2 prior hormonal regimens for advanced or metastatic disease. Prior hormonal regimens in combination with CDK4/6 inhibitors are allowed.
  • Has received no more than 1 prior chemotherapy for locally advanced or metastatic breast cancer.

Exclusion Criteria:

  • Prior or concurrent malignancy whose natural history or treatment may interfere with the safety or efficacy assessment of the investigational regimen
  • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
  • History of cerebral vascular disease within 6 months prior to the first administration of study drug dose
  • History of a pulmonary embolism, or deep venous thrombosis within the last 6 months, or subject has an increased risk of thrombosis as determined by the investigator
  • History of pneumonitis or interstitial lung disease
  • Leptomeningeal disease or spinal cord compression
  • Medical history or ongoing gastrointestinal disorders that could affect absorption of oral therapeutics
  • Known human immunodeficiency virus infection
  • Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis (eg, hepatitis B or hepatitis C virus), current alcohol abuse, or cirrhosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05508906


Contacts
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Contact: Myisha Prudhomme (415) 651-7206 clinical@olema.com

Locations
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United States, Florida
Advent Health Hematology and Oncology Recruiting
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Olema Pharmaceuticals, Inc.
Novartis
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Responsible Party: Olema Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05508906    
Other Study ID Numbers: OP-1250-003
First Posted: August 19, 2022    Key Record Dates
Last Update Posted: September 26, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases