Pilot Trial of SP-2577 Plus Pembrolizumab in Select Gynecologic Cancers

NCT04611139 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: HRI-SP-2577-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SCCOHT; Ovarian Clear Cell Tumor; Ovarian Endometrioid Adenocarcinoma; Endometrial Cancer

Outcome Measures

Primary Outcomes (8)

• Incident of AEs

  Incidence of Adverse Events (AEs) as measured by NCI CTCAE version 5.0

  First dose to 90 days after last dose

• Incident of DLTs

  Incidence of dose-limiting toxicities (DLTs) during the dose escalation phase

  First dose to 90 days after last dose

• Overall Response Rate

  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

  Study enrollment until participant discontinuation, occurrence of PD or death (approximately 6 months to 3 years)

• Disease Control Rate

  Percentage of participants with Disease Control (complete response, partial response, or stable disease) as determined by RECIST v1.1

  Study enrollment until PD or loss of clinical benefit (approximately 6 months to 3 years)

• Duration of Response

  Duration of Response as determined by the Investigator according to RECIST v1.1

  Date of first occurrence of objective response to first documentation of PD (approximately 6 months to 3 years)

• Duration of Stable Disease

  Duration of Stable Disease as determined by the investigator according to RECIST v 1.1

  Date of first occurrence of stable disease to first documentation of PD (approximately 6 months to 3 years)

• Progression Free Survival

  Progression Free Survival (PFS) as determined by the Investigator according to RECIST v1.1

  Start of treatment to first occurrence of PD or death (approximately 6 months to 3 years)

• Overall Survival

  Overall Survival (OS) as determined by the Investigator according to RECIST v1.1

  Start of treatment to death (approximately 2 to 3 years)

Secondary Outcomes (3)

• Plasma Concentration of SP-2577

  2 months

• ctDNA in blood and other body fluids

  6 months to 2 years

• Target Inhibition in Tumor Biopsies

  6 months to 2 years

Study Arms (1)

SP-2577 Plus Pembrolizumab

EXPERIMENTAL

Drug: SP-2577; Drug: Pembrolizumab

Interventions

SP-2577 DRUG

Daily oral doses

SP-2577 Plus Pembrolizumab

Pembrolizumab DRUG

200mg Q3W by IV infusion

SP-2577 Plus Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Type of cancer being evaluated (ovarian and endometrial)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HonorHealth Research Institute: lead
• Merck Sharp & Dohme LLC: collaborator
• Salarius Pharmaceuticals, LLC: collaborator

Study Sites (1)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: November 2, 2020
• Study Start: December 31, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)