Study of STP938 in Advanced Solid Tumours

NCT06297525 | Recruiting Phase 1 FDA Drug

• 1 other identifier: STP938-201
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)

  Through study completion, an average of 6 months

Secondary Outcomes (8)

• Area under the curve (AUC) of STP938

  9 days

• Maximum plasma concentration (Cmax)

  9 Days

• Time to reach maximum concentration (TMax)

  9 Days

• Evaluation of preliminary clinical activity of STP938

  Through study completion, an average of 6 months

• Evaluation of best overall response of STP938

  Through study completion, an average of 6 months

Study Arms (2)

Phase 1a (Part 1, Dose Escalation)

EXPERIMENTAL

Up to 5 dose levels with STP938 administered as oral monotherapy

Drug: STP938

Phase 1b (Part 2, Safety Expansion)

EXPERIMENTAL

Further evaluation of STP938 administered as oral monotherapy at the RP2D

Drug: STP938

Interventions

STP938 DRUG

Small molecule

Phase 1a (Part 1, Dose Escalation); Phase 1b (Part 2, Safety Expansion)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Step Pharma, SAS: lead

Study Sites (7)

Comprehensive Hematology Oncology, LLC

St. Petersburg, Florida, 33709, United States

RECRUITING

Mary Crowley Cancer Research Center

Dallas, Texas, 75251, United States

RECRUITING

Next Oncology

San Antonio, Texas, 78292, United States

RECRUITING

Institut Gustave Roussy

Villejuif, Paris, 94805, France

RECRUITING

The Beatson Institute for Cancer Research

Glasgow, Glasgow, G12 8QQ, United Kingdom

RECRUITING

University College London

London, United Kingdom

RECRUITING

The Christie

Manchester, M20 4BX, United Kingdom

RECRUITING

Study Officials

• Maureen Higgins

  Step Pharma

  STUDY DIRECTOR

Central Study Contacts

Maureen Higgins

CONTACT

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

Duc Tran

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be assigned to a dose level of STP938 (Phase 1a) or an expansion cohort (Phase 1b) at the time of their enrollment.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 7, 2024
• Study Start: August 2, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (3); FR (1); GB (3)