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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05508906




Registration number
NCT05508906
Ethics application status
Date submitted
16/08/2022
Date registered
19/08/2022
Date last updated
11/01/2024

Titles & IDs
Public title
Phase 1b Combo w/ Ribociclib and Alpelisib
Scientific 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
Secondary ID [1] 0 0
OP-1250-003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Advanced Breast Cancer 0 0
HR-positive Breast Cancer 0 0
HER2-negative Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OP-1250
Treatment: Drugs - Ribociclib
Treatment: Drugs - Alpelisib

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

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


Treatment: Drugs: 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.

Treatment: Drugs: Ribociclib
All subjects in Treatment Group 1 will receive OP-1250 in combination with ribociclib.

Treatment: Drugs: Alpelisib
All subjects in Treatment Group 2 will receive OP-1250 in combination with alpelisib.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
The first 28 days of treatment
Primary outcome [2] 0 0
Characterize the incidence, nature and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2)
Timepoint [2] 0 0
Up to 35 days after end of treatment
Primary outcome [3] 0 0
Pharmacokinetics (PK) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2)
Timepoint [3] 0 0
Every 28 days
Secondary outcome [1] 0 0
Preliminarily assess the anti-tumor activity of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2)
Timepoint [1] 0 0
Up to 1 year
Secondary outcome [2] 0 0
Evaluate clinical benefit rate (CBR) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2)
Timepoint [2] 0 0
Up to 1 year
Secondary outcome [3] 0 0
Evaluate duration of response (DOR) of OP-1250 when administered with ribociclib (Treatment Group 1) or alpelisib (Treatment Group 2)
Timepoint [3] 0 0
Up to 1 year

Eligibility
Key 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 1 prior hormonal regimen (Treatment Group 1). Has received
no more than 2 prior hormonal regimens (Treatment Group 2) for advanced or metastatic
disease. Prior hormonal regimens in combination with CDK4/6 inhibitors are allowed.

- Has received no more than 1 prior chemotherapy (which includes antibody drug
conjugates) for locally advanced or metastatic breast cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/08/2024
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Breast Cancer Research Center- Western Australia - Nedlands
Recruitment hospital [2] 0 0
Macquarie Health - New South Wales
Recruitment postcode(s) [1] 0 0
6009 - Nedlands
Recruitment postcode(s) [2] 0 0
2109 - New South Wales
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Olema Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novartis
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05508906
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mark Shilkrut, M.D.
Address 0 0
Olema Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial OP-1250-003 Study
Address 0 0
Country 0 0
Phone 0 0
415 651 7206
Fax 0 0
Email 0 0
clinical@olema.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05508906