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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) (Phase 2 / Dose Expansion)
Safety and Tolerability (Phase 1 / Dose Escalation)
Secondary outcome measures
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 moreTrial 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
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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
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants is the research team recruiting for this trial?
"Affirmative. The information hosted on clinicaltrials.gov indicates that this medical trial is actively seeking participants, which were first posted about on August 3rd 2022 and subsequently edited at the beginning of September 2020. Altogether, 180 people need to be recruited from 2 separate sites."
Answered by AI
What purpose does this trial seek to achieve?
"Step Pharma, SAS has reported that their main objective for this trial is Objective Response Rate (ORR). This outcome will be measured over an average 9-month period. Additionally, secondary outcomes such as Maximum plasma concentration (Cmax), Duration of response (DoR) and Area under the curve (AUC) are also being monitored throughout Phases 1 and 2."
Answered by AI
Are there any opportunities for people to partake in this clinical trial at present?
"As per the information provided on clinicaltrials.gov, this study is actively recruiting individuals to participate in it. The trial was initially advertised on August 3rd 2022 and has since been revised as recently as September 5th 2022."
Answered by AI
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