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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 9 months
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 moreAwards & 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
Manish Patel, MDPrincipal InvestigatorFlorida Cancer Specialists
2 Previous Clinical Trials
33 Total Patients Enrolled
Matthew Ahearne, MB ChBPrincipal InvestigatorUniversity Hospitals, Leicester
Ian Flinn, MD, PhDPrincipal InvestigatorTennessee Oncology
5 Previous Clinical Trials
168 Total Patients Enrolled
Michael Tees, MD, MPHPrincipal InvestigatorColorado Blood Cancer Institute
1 Previous Clinical Trials
1 Total Patients Enrolled
Maureen Higgins, PhDStudy DirectorStep Pharma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant, breastfeeding, and if capable of childbearing or fathering a child, I agree to use contraception.My cancer has spread to my brain or spinal cord.I have had cancer within the last 2 years.My lymphoma has returned or didn't respond to treatment.I do not have any unmanaged ongoing illnesses.I have not received a live vaccine in the last 30 days.I am 18 years old or older.I've had at least 2 treatments for my condition and have no other known beneficial treatment options.My vital organs are functioning well.I have a weakened immune system and had an opportunistic infection in the past year.All my side effects from previous cancer treatments, except hair loss, are mild or gone.I had radiation or surgery for lymphoma with no measurable disease outside the treated area.I haven't had cancer treatments or experimental drugs in the last 4 weeks.I can take care of myself but might not be able to do heavy physical work.I have an active hepatitis B or C infection.I received a COVID-19 vaccine less than 3 weeks before starting the study drug.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 (Part 1, Dose Escalation)
- Group 2: Phase 2 (Part 2; expansion)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.