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A Phase 1/2 Study of STP938 (Dencatistat) for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas

ConditionsLymphoma, B-CellLymphoma, T-Cell
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorStep Pharma, SAS

About this trial

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

The Phase 2 part of the study is cohort expansion of STP938 as a monotherapy in 5 different B and T cell lymphomas.

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.

Relapsed/refractory patients with histologically confirmed diagnosis of B cell or T cell lymphoma

Must have received at least 2 prior systemic therapies and have no treatment options known to provide clinical benefit

Disqualifiers

Pregnant or breastfeeding females and women of child bearing potential or males unwilling to comply with contraception requirements.

Known carcinomatous meningitis or central nervous system (CNS) involvement with lymphoma.

Active malignancy within 2 years of study enrollment

Prior radiation or surgical resection of their lymphoma without additional sites of measurable disease outside of the radiation field or subjects who have received prior radiation or surgical resection of their lymphoma ≤2 weeks prior to the first dose of study drug.

Trial design

Design model

Sequential

Treatments tested in this trial

  • STP938

    Drug

    Small molecule

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Phase 1 (Part 1, Dose Escalation)Experimental treatment 1 intervention
Group B: Phase 2 (Part 2; expansion)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety and Tolerability (Phase 1 / Dose Escalation)

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

Time frame
Through study completion, an average of 9 months
2

Objective Response Rate (ORR) (Phase 2 / Dose Expansion)

ORR is defined as the proportion of subjects achieving a confirmed response (complete response \[CR\] or partial response \[PR\]). Evaluation of ORR will be via standard response criteria

Time frame
Through study completion, an average of 9 months

Secondary outcomes

1

Maximum plasma concentration (Cmax) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)

Pharmacokinetic parameter from plasma STP938 levels

Time frame
16 Days
2

Time to reach maximum concentration (TMax) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)

Pharmacokinetic parameter from plasma STP938 levels

Time frame
16 Days
3

Area under the curve (AUC) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)

Pharmacokinetic parameter from plasma STP938 levels

Time frame
16 Days
4

Evaluate preliminary clinical activity of STP938 (Phase 1)

Evaluation of ORR using standard response criteria

Time frame
Through study completion, an average of 9 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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