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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06784193




Registration number
NCT06784193
Ethics application status
Date submitted
14/01/2025
Date registered
20/01/2025
Date last updated
15/05/2025

Titles & IDs
Public title
Study of OP-3136 in Advanced or Metastatic Solid Tumors
Scientific title
A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors
Secondary ID [1] 0 0
OP-3136-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced or Metastatic ER+ HER2- Breast Cancer (mBC) 0 0
Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) 0 0
Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - OP-3136

Experimental: Part 1 Dose Escalation -

Experimental: Part 2 Dose Expansion - mBC -

Experimental: Part 2 Dose Expansion - mCRPC -


Treatment: Drugs: OP-3136
OP-3136
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with dose-limiting toxicities in the Dose Escalation Arms
Timepoint [1] 0 0
Up to 28 days
Primary outcome [2] 0 0
Incidence of adverse events and laboratory abnormalities
Timepoint [2] 0 0
Up to 26 months
Secondary outcome [1] 0 0
Maximum observed concentration (Cmax)
Timepoint [1] 0 0
Up to 26 months
Secondary outcome [2] 0 0
Time to maximum concentration (Tmax)
Timepoint [2] 0 0
Up to 26 months
Secondary outcome [3] 0 0
Area under the curve from time zero to 24 hours (AUC0-24)
Timepoint [3] 0 0
Up to 26 months
Secondary outcome [4] 0 0
Overall Response Rate (ORR)
Timepoint [4] 0 0
Up to 26 months
Secondary outcome [5] 0 0
Duration of Response (DOR)
Timepoint [5] 0 0
Up to 26 months
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR)
Timepoint [6] 0 0
Up to 26 months

Eligibility
Key inclusion criteria
Key

* Participants with advanced or metastatic ER+HER2- breast cancer, mCRPC, or NSCLC (Part 1) or advanced or metastatic ER+HER2- BC or mCRPC (Part 2).
* Part 1 (Dose escalation): Participants must have a tumor that is unresectable or metastatic and for which life prolonging measures do not exist or available therapies are intolerable or no longer effective.
* Part 2 (Dose Expansion in ER+ HER2- mBC): Participants must have received up to 3 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and up to 1 prior line of chemotherapy or an antibody-drug conjugate.
* Part 2 (Dose Expansion in mCRPC): Participants must have received up to 4 lines of prior systemic therapy for prostate cancer. Prior therapy must include treatment with an androgen receptor pathway inhibitor(s).

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior therapy with KAT6A/B inhibitor in any treatment setting.
* Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term.
* Known active or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require CNS-specific treatment, or participants who did not demonstrate clinical and radiologic stability during the last 2 months prior to the first dose of study treatment or require or are currently on steroid therapy for CNS metastases.
* History of cerebral vascular disease, including transient ischemic attack, within 6 months prior to the first dose of study treatment.
* History of or ongoing impaired cardiac function or clinically significant cardiac disease within 6 months prior to the first dose of study treatment.

Note: Additional inclusion/exclusion criteria may apply.

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
Other
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
16/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2027
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Cancer Research South Australia - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Utah

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Olema Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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 Olema Clinical Trial Lead
Address 0 0
Country 0 0
Phone 0 0
415-651-7206
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06784193