Study of STP938 in Advanced Solid Tumours

Step Pharma

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor

Treatments: Drug: STP938

Study type: Interventional

Funder types: Industry

Identifiers

NCT06297525

STP938-201

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

70 participants in 2 patient groups

Phase 1a (Part 1, Dose Escalation)

Experimental group

Description:

Up to 5 dose levels with STP938 administered as oral monotherapy

Treatment:

Drug: STP938

Phase 1b (Part 2, Safety Expansion)

Experimental group

Description:

Further evaluation of STP938 administered as oral monotherapy at the RP2D

Treatment:

Drug: STP938