SCCOHTPhase 1NCT04611139
Pilot Trial of SP-2577 Plus Pembrolizumab in Select Gynecologic Cancers
A Phase 1 study testing SP-2577 and Pembrolizumab in people with SCCOHT and Ovarian Clear Cell Tumor, run by HonorHealth Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- SCCOHT, Ovarian Clear Cell Tumor, Ovarian Endometrioid Adenocarcinoma
- What is being tested?
- SP-2577 and Pembrolizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2021to 30 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
HonorHealth Research Institute
Scottsdale, Arizona, 85258
About this study
Official title: 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.
Read the 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).
- Being tested
- SP-2577, Pembrolizumab
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-2577Drug
Daily oral doses
PembrolizumabDrug
200mg Q3W by IV infusion
| Study group | Role | What they receive |
|---|---|---|
| SP-2577 Plus Pembrolizumab | Experimental | Not described Receives: Drug: SP-2577; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident of AEs
Incidence of Adverse Events (AEs) as measured by NCI CTCAE version 5.0
Measured: First dose to 90 days after last dose
Incident of DLTs
Incidence of dose-limiting toxicities (DLTs) during the dose escalation phase
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Start of treatment to death (approximately 2 to 3 years)
Secondary outcomes (3)
Plasma Concentration of SP-2577
Plasma concentration of seclidemstat (SP-2577)
Measured: 2 months
ctDNA in blood and other body fluids
Proportion of circulating tumor DNA ( ctDNA) in peripheral blood and other body fluids e.g. ascitic fluid
Measured: 6 months to 2 years
Target Inhibition in Tumor Biopsies
Percentage of target inhibition by seclidemstat and pembrolizumab in tumor tissue biopsy specimens
Measured: 6 months to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start31 Dec 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Why it stopped: Salarius discontinued support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCCOHTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HonorHealth Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Salarius Pharmaceuticals, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611139
- Sponsor's protocol ID
- HRI-SP-2577-001
- Status last verified
- Feb 2022
- First submitted
- 24 Sep 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility and Efficacy Trial of a Novel Reversible LSD1 Inhibitor SP-2577 (Seclidemstat) Plus Pembrolizumab in Select SWI/SNF-mutant Gynecologic Cancers
- ClinicalTrials.gov ID
- NCT04611139
- Acronym / sponsor ID
- HRI-SP-2577-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Salarius discontinued support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HonorHealth Research InstituteUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Salarius Pharmaceuticals, LLC
- Study start
- 31 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 2 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SP-2577 Plus Pembrolizumab | Experimental | Drug: SP-2577, Drug: Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SP-2577Daily oral doses | Drug | SP-2577 Plus Pembrolizumab |
| Pembrolizumab200mg Q3W by IV infusion | Drug | SP-2577 Plus Pembrolizumab |
Primary outcome
Incident of AEs
Time frame: First dose to 90 days after last dose
Incidence of Adverse Events (AEs) as measured by NCI CTCAE version 5.0
Incident of DLTs
Time frame: First dose to 90 days after last dose
Incidence of dose-limiting toxicities (DLTs) during the dose escalation phase
Overall Response Rate
Time frame: Study enrollment until participant discontinuation, occurrence of PD or death (approximately 6 months to 3 years)
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
Disease Control Rate
Time frame: Study enrollment until PD or loss of clinical benefit (approximately 6 months to 3 years)
Percentage of participants with Disease Control (complete response, partial response, or stable disease) as determined by RECIST v1.1
Duration of Response
Time frame: Date of first occurrence of objective response to first documentation of PD (approximately 6 months to 3 years)
Duration of Response as determined by the Investigator according to RECIST v1.1
Duration of Stable Disease
Time frame: Date of first occurrence of stable disease to first documentation of PD (approximately 6 months to 3 years)
Duration of Stable Disease as determined by the investigator according to RECIST v 1.1
Progression Free Survival
Time frame: Start of treatment to first occurrence of PD or death (approximately 6 months to 3 years)
Progression Free Survival (PFS) as determined by the Investigator according to RECIST v1.1
Overall Survival
Time frame: Start of treatment to death (approximately 2 to 3 years)
Overall Survival (OS) as determined by the Investigator according to RECIST v1.1
3 secondary outcomes
Plasma Concentration of SP-2577
Time frame: 2 months
ctDNA in blood and other body fluids
Time frame: 6 months to 2 years
Target Inhibition in Tumor Biopsies
Time frame: 6 months to 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: No
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Small Cell Ovarian Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SP-2577 and Pembrolizumab in people with SCCOHT and Ovarian Clear Cell Tumor, run by HonorHealth Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident of AEs (time frame: First dose to 90 days after last dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.