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Study of STP938 (Dencatistat) in Advanced Solid Tumours

ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStep Pharma, SAS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • STP938

    Drug

    Small molecule

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Phase 1a (Part 1, Dose Escalation)Experimental treatment 1 intervention
Group B: Phase 1b (Part 2, Safety Expansion)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Tolerability

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

Time frame
Through study completion, an average of 6 months

Secondary outcomes

1

Area under the curve (AUC) of STP938

Pharmacokinetic parameter from plasma STP938 levels

Time frame
9 days
2

Maximum plasma concentration (Cmax)

Pharmacokinetic parameter from plasma STP938 levels

Time frame
9 Days
3

Time to reach maximum concentration (TMax)

Pharmacokinetic parameter from plasma STP938 levels

Time frame
9 Days
4

Evaluation of preliminary clinical activity of STP938

Evaluation of ORR using standard response criteria

Time frame
Through study completion, an average of 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Step Pharma, SAS

Lead sponsor

Source ClinicalTrials.gov
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