Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-04-18 @ 11:52 AM
Study NCT ID:
NCT06784193
Status:
RECRUITING
Last Update Posted:
2025-10-10
First Post:
2025-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077267', 'term': 'Fulvestrant'}], 'ancestors': [{'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-08', 'studyFirstSubmitDate': '2025-01-14', 'studyFirstSubmitQcDate': '2025-01-14', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with dose-limiting toxicities in the Dose Escalation Arms', 'timeFrame': 'Up to 28 days'}, {'measure': 'Incidence of adverse events and laboratory abnormalities', 'timeFrame': 'Up to 26 months'}], 'secondaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Up to 26 months'}, {'measure': 'Time to maximum concentration (Tmax)', 'timeFrame': 'Up to 26 months'}, {'measure': 'Area under the curve from time zero to 24 hours (AUC0-24)', 'timeFrame': 'Up to 26 months'}, {'measure': 'Overall Response Rate (ORR)', 'timeFrame': 'Up to 26 months'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 26 months'}, {'measure': 'Clinical Benefit Rate (CBR)', 'timeFrame': 'Up to 26 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['KAT6 Inhibitor', 'Histone Acetyltransferase (HAT) Inhibitor', 'Epigenetic'], 'conditions': ['Advanced or Metastatic ER+ HER2- Breast Cancer (mBC)', 'Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)', 'Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC)', 'Metastatic Breast Cancer', 'Fulvestrant', 'Palazestrant']}, 'descriptionModule': {'briefSummary': 'This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, as monotherapy and in combination with other anticancer agents in participants with advanced solid tumors.\n\nThis study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part (Part 2).', 'detailedDescription': 'Part 1A (Dose Escalation for OP-3136 Monotherapy): This part of the study will evaluate the safety, tolerability, and PK in a range of doses of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, administered orally once daily to participants with ER+ HER2- advanced or metastatic breast cancer (mBC), advanced or metastatic castration resistant prostate cancer (mCRPC), or advanced or metastatic non-small cell lung cancer (mNSCLC), and determine the maximum tolerated dose (MTD) and the recommended dose/regimen for expansion (RDE).\n\nPart 1B (Dose Escalation for OP-3136 in Combination with Fulvestrant): This part of the study will evaluate the safety and PK of OP-3136 administered in combination with fulvestrant in participants with ER+ HER2- mBC, and determine MTD and RDE for this combination.\n\nPart 1C (Dose Escalation for OP-3136 in Combination with Palazestrant): This part of the study will evaluate the safety and PK of OP-3136 administered in combination with palazestrant in participants with ER+ HER2- mBC, and determine MTD and RDE for this combination.\n\nPart 2A (Dose Expansion for OP-3136 Monotherapy): This part will evaluate two expansion cohorts at the monotherapy RDE from part 1 in participants with ER+ HER2- mBC and participants with mCRPC.\n\nPart 2B (Dose Expansion for OP-3136 in Combination with Fulvestrant OR Palazestrant): This part will evaluate the RDEs for OP-3136 in combination with fulvestrant from Part 1B OR the RDEs of OP-3136 in combination with palazestrant in an expansion cohort in participants with ER+ HER2- mBC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* 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).\n* Part 1A (Dose escalation for OP-3136 monotherapy): 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.\n* Part 1B (Dose escalation for OP-3136 in combination with fulvestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting.\n* Part 1C (Dose escalation for OP-3136 in combination with palazestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting.\n* Part 2A (Dose Expansion in ER+ HER2- mBC for OP-3136 monotherapy): 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.\n* Part 2A (Dose Expansion in mCRPC for OP-3136 monotherapy): 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).\n* Part 2B (Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with fulvestrant OR Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with palazestrant): Participants must have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting. Participants must have received no more than 2 prior lines of endocrine therapy in the advanced or metastatic setting and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting.\n\nKey Exclusion Criteria:\n\n* Prior therapy with KAT6A/B inhibitor in any treatment setting.\n* Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term.\n* 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.\n* History of cerebral vascular disease, including transient ischemic attack, within 6 months prior to the first dose of study treatment.\n* History of or ongoing impaired cardiac function or clinically significant cardiac disease within 6 months prior to the first dose of study treatment.\n\nNote: Additional inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06784193', 'briefTitle': 'Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Olema Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'OP-3136-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1A Dose Escalation monotherapy', 'interventionNames': ['Drug: OP-3136']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1B Dose Escalation in combination with fulvestrant', 'interventionNames': ['Drug: OP-3136', 'Drug: Fulvestrant']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1C Dose Escalation in combination with palazestrant', 'interventionNames': ['Drug: OP-3136', 'Drug: Palazestrant']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2A Dose Expansion monotherapy - mBC', 'interventionNames': ['Drug: OP-3136']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2A Dose Expansion monotherapy - mCRPC', 'interventionNames': ['Drug: OP-3136']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1', 'interventionNames': ['Drug: OP-3136', 'Drug: Fulvestrant', 'Drug: Palazestrant']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2', 'interventionNames': ['Drug: OP-3136', 'Drug: Fulvestrant', 'Drug: Palazestrant']}], 'interventions': [{'name': 'OP-3136', 'type': 'DRUG', 'description': 'Selective inhibitor of HAT enzymes KAT6A and KAT6B', 'armGroupLabels': ['Part 1A Dose Escalation monotherapy', 'Part 1B Dose Escalation in combination with fulvestrant', 'Part 1C Dose Escalation in combination with palazestrant', 'Part 2A Dose Expansion monotherapy - mBC', 'Part 2A Dose Expansion monotherapy - mCRPC', 'Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1', 'Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2']}, {'name': 'Fulvestrant', 'type': 'DRUG', 'description': 'Selective estrogen receptor degrader (SERD)', 'armGroupLabels': ['Part 1B Dose Escalation in combination with fulvestrant', 'Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1', 'Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2']}, {'name': 'Palazestrant', 'type': 'DRUG', 'description': 'Complete estrogen receptor antagonist (CERAN)', 'armGroupLabels': ['Part 1C Dose Escalation in combination with palazestrant', 'Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1', 'Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34232', 'city': 'Sarasota', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Florida Cancer Specialists', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University Medical Center - New Orleans', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'START - Midwest', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'SCRI Oncology Partners', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'START - San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84119', 'city': 'West Valley City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'START - Mountain Region', 'geoPoint': {'lat': 40.69161, 'lon': -112.00105}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'facility': 'Cancer Research South Australia', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'centralContacts': [{'name': 'There may be multiple sites in this clinical trial Olema Clinical Trial Lead', 'role': 'CONTACT', 'email': 'clinical@olema.com', 'phone': '415-651-7206'}, {'name': 'Olema Medical Study Director', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Olema Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}