Recruiting
Phase 1

STP938

Sponsor:

Step Pharma, SAS

Code:

NCT06297525

Conditions

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STP938

Study Details

Brief summary:

The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy.

The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.

Conditions

Solid Tumor

Study ID

NCT06297525

Start date

Aug 2, 2024

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Main Inclusion Criteria:

  • Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization.
  • Male or female aged ≥ 18 years.
  • Advanced disease not curable by available therapies and requires systemic therapy.
  • Histologically confirmed diagnosis of eligible cancer type.
  • Must have tumor tissue available for biomarker testing.
  • Measurable disease (Part 1) and measurable disease per RECIST (Part2)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Life expectancy > 3 months as assessed by the Investigator.
  • Adequate organ function (bone marrow, hepatic, renal function and coagulation).
  • All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment.

Main Exclusion Criteria:

  • Pregnant or breastfeeding females and women of childbearing potential or males unwilling to comply with contraception requirements.
  • Known active or symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease or a history of spinal cord compression
  • Active malignancy within 2 years of study enrollment
  • Prior radiation within 2 weeks of start of therapy.
  • Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or <5 half-lives since completion of previous investigational therapy, whichever is shorter.
  • Uncontrolled intercurrent illness.
  • Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months.
  • Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection.
  • Subjects with corrected QT interval >470 msec based on averaged triplicate electrocardiogram (ECG) readings at the Screening Visit using the QT interval corrected for heart rate using Fridericia's method (QTcF).

Study Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a (Part 1, Dose Escalation)

Up to 5 dose levels with STP938 administered as oral monotherapy

experimental: Phase 1b (Part 2, Safety Expansion)

Further evaluation of STP938 administered as oral monotherapy at the RP2D

Interventions

STP938

Small molecule

Primary outcome measure

  • Safety and Tolerability [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts and Locations

Central contacts

Maureen Higgins

+33 1 86 26 43 56STP938-201@step-ph.com

Duc Tran

+33 1 86 26 43 56STP938-201@step-ph.com

Locations

Comprehensive Hematology Oncology, LLC

Recruiting

St. Petersburg, Florida, United States, 33709

Mary Crowley Cancer Research Center

Recruiting

Dallas, Texas, United States, 75251

Next Oncology

Recruiting

San Antonio, Texas, United States, 78292

More Information

Sponsor

Step Pharma, SAS

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Step Pharma, SAS on 2026-06-16.