- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04611139
Pilot Trial of SP-2577 Plus Pembrolizumab in Select Gynecologic Cancers
February 11, 2022 updated by: HonorHealth Research Institute
Pilot Feasibility and Efficacy Trial of a Novel Reversible LSD1 Inhibitor SP-2577 (Seclidemstat) Plus Pembrolizumab in Select SWI/SNF-mutant Gynecologic Cancers
Open-label study of SF-2577 plus pembrolizumab in advanced, recurrent small cell ovarian cancer as well as select additional ovarian and endometrial cancers within the SWI/SNF pathway.
Study Overview
Status
Withdrawn
Intervention / Treatment
Detailed Description
This study is an open-label, non-randomized dose escalation and expansion study of the LSD inhibitor SP-2577 in combination with the anti PD- 1 antibody pembrolizumab in patients with advanced, recurrent small cell ovarian cancer of the hypercalcemic type (SCCOHT) as well as select additional ovarian and endometrial cancers with mutations in the genes within the SWI/SNF pathway (Ovarian Clear Cell Cancers (OCCC), Endometrioid Ovarian Cancers (EOC) and Endometrioid Endometrial Cancers (EEC).
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85258
- HonorHealth Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of small cell carcinoma of the ovary of hypercalcemic type (SCCOHT), ovarian clear cell carcinoma (OCCC), endometrioid ovarian carcinoma (EOC) or endometrioid endometrial carcinoma (EEC) with confirmed mutations in one of the SWI/SNF genes (SMARCA4, ARID1A) will be enrolled in this study.
- Patients must have received at least one prior regimen in the recurrent or advanced setting and must not be a candidate for other potentially curative treatment options.
- Not pregnant, breastfeeding and agrees to use contraceptive methods if child-bearing
- Provides written informed consent
- Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Have provided archival tumor tissue sample or a newly obtained core or excisional biopsy of a tumor lesion not irradiated.
- ECOG of 0 to 1
- Adequate organ function
Exclusion Criteria:
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to allocation.
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent is allowed as long as patient did not have a serious (≥ Grade 3) immune related AE requiring treatment discontinuation or treatment with systemic steroids.
- Has received prior therapy with LSD1 targeted agents including monoamine oxidases for cancer therapy.
- Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks or 5 half-lives whichever is shorter prior to the first dose of study treatment.
- Has received prior radiotherapy within 2 weeks of start of study treatment.
- Has received a live vaccine within 30 days prior to the first dose of study drug.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- Has a known history of HIV, Hepatitis B, or known active Hepatitis C
- Has a known history of active TB
- Has clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
- Is currently receiving any of the following substances and cannot be discontinued 14 days, or 5 half-lives for CYP inhibitors (whichever is shorter) prior to Cycle 1 Day 1
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SP-2577 Plus Pembrolizumab
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Daily oral doses
200mg Q3W by IV infusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incident of AEs
Time Frame: First dose to 90 days after last dose
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Incidence of Adverse Events (AEs) as measured by NCI CTCAE version 5.0
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First dose to 90 days after last dose
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Incident of DLTs
Time Frame: First dose to 90 days after last dose
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Incidence of dose-limiting toxicities (DLTs) during the dose escalation phase
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First dose to 90 days after last dose
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Overall Response Rate
Time Frame: Study enrollment until participant discontinuation, occurrence of PD or death (approximately 6 months to 3 years)
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Percentage of participants with a best overall response of Complete Response (CR) or Partial Response (PR), as determined by Investigator according to Response Evaluation in Solid Tumors (RECIST) v 1.1
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Study enrollment until participant discontinuation, occurrence of PD or death (approximately 6 months to 3 years)
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Disease Control Rate
Time Frame: Study enrollment until PD or loss of clinical benefit (approximately 6 months to 3 years)
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Percentage of participants with Disease Control (complete response, partial response, or stable disease) as determined by RECIST v1.1
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Study enrollment until PD or loss of clinical benefit (approximately 6 months to 3 years)
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Duration of Response
Time Frame: Date of first occurrence of objective response to first documentation of PD (approximately 6 months to 3 years)
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Duration of Response as determined by the Investigator according to RECIST v1.1
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Date of first occurrence of objective response to first documentation of PD (approximately 6 months to 3 years)
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Duration of Stable Disease
Time Frame: Date of first occurrence of stable disease to first documentation of PD (approximately 6 months to 3 years)
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Duration of Stable Disease as determined by the investigator according to RECIST v 1.1
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Date of first occurrence of stable disease to first documentation of PD (approximately 6 months to 3 years)
|
Progression Free Survival
Time Frame: Start of treatment to first occurrence of PD or death (approximately 6 months to 3 years)
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Progression Free Survival (PFS) as determined by the Investigator according to RECIST v1.1
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Start of treatment to first occurrence of PD or death (approximately 6 months to 3 years)
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Overall Survival
Time Frame: Start of treatment to death (approximately 2 to 3 years)
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Overall Survival (OS) as determined by the Investigator according to RECIST v1.1
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Start of treatment to death (approximately 2 to 3 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Concentration of SP-2577
Time Frame: 2 months
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Plasma concentration of seclidemstat (SP-2577)
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2 months
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ctDNA in blood and other body fluids
Time Frame: 6 months to 2 years
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Proportion of circulating tumor DNA ( ctDNA) in peripheral blood and other body fluids e.g.
ascitic fluid
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6 months to 2 years
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Target Inhibition in Tumor Biopsies
Time Frame: 6 months to 2 years
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Percentage of target inhibition by seclidemstat and pembrolizumab in tumor tissue biopsy specimens
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6 months to 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
December 31, 2021
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
June 30, 2024
Study Registration Dates
First Submitted
September 24, 2020
First Submitted That Met QC Criteria
October 26, 2020
First Posted (Actual)
November 2, 2020
Study Record Updates
Last Update Posted (Actual)
March 2, 2022
Last Update Submitted That Met QC Criteria
February 11, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Ovarian Neoplasms
- Endometrial Neoplasms
- Carcinoma, Endometrioid
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Pembrolizumab
Other Study ID Numbers
- HRI-SP-2577-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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