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Monoclonal Antibodies

STP938 for Lymphoma

Phase 1 & 2
Recruiting
Led By David Lewis, MB ChB
Research Sponsored by Step Pharma, SAS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 9 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, STP938, to see if it is safe and effective in treating B and T cell lymphomas.

Who is the study for?
Adults over 18 with B-cell or T-cell lymphoma that's come back or hasn't responded to treatment can join this trial. They must have tried at least two other treatments and have no other options left. Participants need good organ function, measurable disease, a decent performance status, and a life expectancy of more than three months.
What is being tested?
STP938 is being tested in adults with certain types of lymphoma. The first phase will find the right dose of STP938 when used alone. The second phase will see how well it works on its own in different groups of patients with B and T cell lymphomas.
What are the potential side effects?
Specific side effects for STP938 are not listed here, but common ones for cancer drugs include nausea, fatigue, blood count changes leading to increased infection risk or bleeding problems, liver issues, and allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR) (Phase 2 / Dose Expansion)
Safety and Tolerability (Phase 1 / Dose Escalation)
Secondary study objectives
Area under the curve (AUC) of STP938 including effects of food on absorption (Phase 1 / Dose Escalation)
Evaluate best overall response of STP938 (Phase 1 / Phase 2)
Evaluate preliminary clinical activity of STP938 (Phase 1)
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2 (Part 2; expansion)Experimental Treatment1 Intervention
At defined dose level(s) with STP938 administered as oral monotherapy
Group II: Phase 1 (Part 1, Dose Escalation)Experimental Treatment1 Intervention
Up to 5 dose levels with STP938 administered as oral monotherapy

Find a Location

Who is running the clinical trial?

Step Pharma, SASLead Sponsor
1 Previous Clinical Trials
70 Total Patients Enrolled
Maureen HigginsStudy DirectorStep Pharma
1 Previous Clinical Trials
70 Total Patients Enrolled
David Lewis, MB ChBPrincipal InvestigatorUniversity Hospitals Plymouth NHS Trust

Media Library

STP938 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05463263 — Phase 1 & 2
Non-Hodgkin's Lymphoma Research Study Groups: Phase 1 (Part 1, Dose Escalation), Phase 2 (Part 2; expansion)
Non-Hodgkin's Lymphoma Clinical Trial 2023: STP938 Highlights & Side Effects. Trial Name: NCT05463263 — Phase 1 & 2
STP938 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05463263 — Phase 1 & 2
~55 spots leftby Dec 2025
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