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Advanced Solid TumorsPhase 1NCT03895684

Phase 1 Trial of the LSD1 Inhibitor SP-2577 (Seclidemstat) in Patients With Advanced Solid Tumors

A Phase 1 study testing SP-2577 Seclidemstat in people with Advanced Solid Tumors, run by Salarius Pharmaceuticals, LLC at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase 1, open-label, non-randomized dose finding study of SP-2577 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
SP-2577 Seclidemstat
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
2 sitesUnited States
Study dates
25 Jun 2019to 13 Apr 2021
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age ≥ 12 years and weight ≥ 40 kg.
  • Diagnosis of advanced or recurrent, histologically or cytologically confirmed, solid malignancy that is either metastatic or unresectable. At time of enrollment, subjects must have progressed on, be intolerant of, refuse, or ineligible for, all available standard of care therapies.
  • Subjects must demonstrate measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, with the exception of castration-resistant prostate cancer (CRPC) who should have progression based on the PCWG 3.0 criteria
  • Karnofsky ≥70% for over ≥16 years old and Lansky ≥70% for under 16 years old, equivalent to Eastern Cooperative Oncology Group (ECOG) performance status grade 0 or 1
  • Willingness to provide tumor biopsies of assessible lesions on and off treatment (Dose expansion cohort only). Optional for patients <18 years of age.
  • Able to swallow and retain orally administered medication.
  • Patients must have normal organ and marrow function
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Subjects with Ewing Sarcoma. See NCT03600649, Protocol Number: SALA-002-EW16.
  • Subjects with primary central nervous system tumors
  • Patients who have not recovered to grade 1 or baseline from adverse events related to prior therapy excluding lymphopenia, alopecia, peripheral neuropathy and ototoxicity, which are excluded if ≥ CTCAE grade 3 (Version 5.0).
  • Patients who are receiving any other investigational agents.
  • Prior therapy with LSD1 targeted agents including monoamine oxidases for cancer therapy.
  • Prior systemic anti-cancer treatment (chemotherapy, biologic therapy [ie. small molecular inhibitors, monoclonal antibodies]) within 21 days prior to Cycle 1 Day 1.
Show all 20Show fewer
  • Prior therapy with immunotherapy such as a checkpoint inhibitor, cellular therapy or vaccine therapy within 28 days prior to Cycle 1 Day 1. Patients must have recovered from any immune-related adverse events to grade 1 or baseline and require ≤ 10 mg of prednisone equivalents daily. Patients with immune-related hypothyroidism and/or hypoadrenalism may enroll while on thyroid or hydrocortisone replacement therapy, respectively.
  • Prior small port palliative radiotherapy within 14 days or 42 days from definitive local control radiation (any dose greater than 50Gy).
  • Anti-androgen therapies for prostate cancer, such as bicalutamide, within 4 weeks prior to enrollment. Second-line hormone therapies such as enzalutamide, abiraterone, or orteronel within 2 weeks prior to enrolment. Subjects with prostate cancer should remain on luteinizing hormone releasing hormone (LHRH) agonists or antagonists. Subjects with prostate cancer may also remain on low-dose prednisone or prednisolone up to 10 mg/day
  • Prior therapy with long acting myeloid growth factor within 14 days or 7 days from a short acting myeloid growth factor.
  • Participation in a prior investigational study within 30 days prior to Cycle 1 Day 1.
  • Patients with progressive or symptomatic brain metastases. Patients with brain metastases may be included in this trial as long as the brain metastases have received definitive treatment and are stable (i.e., no evidence of progression). The brain metastases must be stable for a minimum of 6 weeks.
  • Patients must have discontinued anti-seizure medications and steroids, except for physiologic steroid dosing (≤10 mg/day of prednisone equivalents).
  • Patients currently receiving any of the following substances and cannot be discontinued 14 days prior to Cycle 1 Day 1: Moderate or strong inhibitors or inducers of major CYP isoenzymes, including grapefruit, grapefruit hybrids, pomelos, star-fruit, and Seville oranges; Moderate or strong inhibitors or inducers of major drug transporters; Substrates of CYP3A4/5 with a narrow therapeutic index
  • Uncontrolled concurrent illness including, but not limited to: ongoing or active infection; transfusion dependent thrombocytopenia or anemia; psychiatric illness/social situations that would limit compliance with study requirements
  • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following: symptomatic congestive heart failure; Left Ventricular Ejection Fraction (LVEF) ≤ 50%; unstable angina pectoris or cardiac arrhythmia; baseline QTcF (Fridericia) ≥ 450 milliseconds; Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome
  • Any major surgery within 21 days prior to Cycle 1 Day 1.
  • Pregnant and breastfeeding women
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
  • HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with SP-2577. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Sarcoma Oncology Research Center

    Santa Monica, California, 90403

  • HonorHealth

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Phase 1, open-label, non-randomized dose finding study of SP-2577 in patients with advanced solid tumors.

Read the detailed description

Phase 1, open-label, non-randomized dose finding study of SP-2577 given as oral tablets in patients with advanced solid tumors in 28-day cycles. The study design is based on a Simon's 4B design without intrapatient dose escalation.

Being tested
SP-2577 Seclidemstat

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SP-2577 SeclidemstatDrug

    Also called LSD1 Inhibitor

    Dose escalation and dose expansion of SP-2577.

Study groups in NCT03895684
Study groupRoleWhat they receive
Sp-2577ExperimentalTwice-daily administration of oral SP-2577
Receives: Drug: SP-2577 Seclidemstat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of SP-2577

    Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0

    Measured: From screening through at least 30 days after end of treatment, up to approximately 24 months

Secondary outcomes (12)

  1. Determine the maximum tolerated dose of SP-2577

    Defined as the dose level immediately below the dose level at which ≥ 2 patients from a cohort of 3 to 6 patients experience a dose-limiting toxicity (DLT).

    Measured: DLTs within the first cycle of therapy (up to 28 days)

  2. Characterization of pharmacokinetics of SP-2577 (area under the concentration time profile)

    SP-2577 under fasted and fed conditions

    Measured: At protocol defined time points on cycle 1 (each cycle is 28 days), day 1 and 2 and cycle 2, day 1 and 2.

  3. Characterization of pharmacokinetics of SP-2577 (time to maximum plasma concentration)

    SP-2577 under fasted and fed conditions

    Measured: At protocol defined time points on cycle 1 (each cycle is 28 days), day 1 and 2 and cycle 2, day 1 and 2.

  4. Characterization of pharmacokinetics of SP-2577 (maximum plasma concentration)

    SP-2577 under fasted and fed conditions

    Measured: At protocol defined time points on cycle 1 (each cycle is 28 days), day 1 and 2 and cycle 2, day 1 and 2.

  5. Characterization of pharmacokinetics of SP-2577 (half-life)

    SP-2577 under fasted and fed conditions

    Measured: At protocol defined time points on cycle 1 (each cycle is 28 days), day 1 and 2 and cycle 2, day 1 and 2.

  6. Characterization of pharmacokinetics of SP-2577 (clearance rate)

    SP-2577 under fasted and fed conditions

    Measured: At protocol defined time points on cycle 1 (each cycle is 28 days), day 1 and 2 and cycle 2, day 1 and 2.

  7. Characterization of pharmacokinetics of SP-2577 (volume of distribution)

    SP-2577 under fasted and fed conditions

    Measured: At protocol defined time points on cycle 1 (each cycle is 28 days), day 1 and 2 and cycle 2, day 1 and 2.

  8. Efficacy parameter: overall response rate of SP-2577

    Assessed by radiographic imaging with response and progression evaluated by RECIST 1.1 guidelines

    Measured: From start of treatment through at least 30 days after end of treatment, up to approximately 24 months

  9. Efficacy parameter: duration of response of SP-2577

    Assessed by radiographic imaging with response and progression evaluated by RECIST 1.1 guidelines

    Measured: From start of treatment through at least 30 days after end of treatment, up to approximately 24 months

  10. Efficacy parameter: progression-free survival of SP-2577

    Assessed by radiographic imaging with response and progression evaluated by RECIST 1.1 guidelines

    Measured: From start of treatment through at least 30 days after end of treatment, up to approximately 24 months

  11. Changes in serum hemoglobin F concentrations

    Determine changes serum hemoglobin F concentrations correlated with SP-2577 treatment and clinical and radiographic markers of disease burden (either response or resistance/progression).

    Measured: At protocol defined time points from start of treatment through end of treatment, up to approximately 24 months

  12. Changes in the molecular signatures of the tumor

    Assessed in dose expansion only by RNA-seq testing of tumor biopsy samples to determine changes in gene expression patterns by SP-2577 treatment to elucidate biological changes induced in the tumor by LSD1 inhibition.

    Measured: At protocol defined time points from start of treatment through end of treatment, up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2019
  2. Study start25 Jun 2019
  3. Primary completion13 Apr 2021
  4. Study completion13 Apr 2021

Resources

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
Model description
This single arm study will utilize an accelerated dose escalation, followed by a conventional 3+3 dose escalation phase to achieve maximum tolerated dose (MTD).
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03895684
Sponsor's protocol ID
SALA-003-AC19
Status last verified
Oct 2021
First submitted
14 Feb 2019
Last updated
18 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SP-2577 Seclidemstat in people with Advanced Solid Tumors, run by Salarius Pharmaceuticals, LLC at 2 sites 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 20 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: finished, as of the sponsor's last update on 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerability of SP-2577 (time frame: From screening through at least 30 days after end of treatment, up to approximately 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03895684.

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 18 Oct 2021.

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