What this study is
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.
What's being tested
- STP938
Intervention · DRUG
Small molecule
Study details
- Official title
- An Open-Label, First in Human, Phase 1/2 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the CTPS1 Inhibitor STP938 In Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas
- Sponsor
- Step Pharma, SAS
- Conditions
- Lymphoma, B-Cell · Lymphoma, T-Cell
- Enrolling
- 180 people
- Starts
- 2022-08-03
- Est. completion
- 2026-12
- Design
- Open-label, non-randomized, sequential groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
- Must have measurable disease per Lugano lymphoma classification except for cutaneous T-cell lymphoma (CTCL) which is measured via International Society for Cutaneous Lymphomas (ISCL)/ European Organization of Research and Treatment of Cancer (EORTC).
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Life expectancy > 3 months as assessed by the Investigator.
- Adequate organ function (bone marrow, hepatic, renal function and coagulation).
- All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment.
You can't join if
- 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.
- Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or <5 half-lives since completion of previous investigational therapy, whichever is shorter.
- Uncontrolled intercurrent illness.
- Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months.
- Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection.
- Subjects who have received a live vaccine within 30 days prior to study enrollment or whilst participating in the study.
- Subjects with corrected QT interval >470 msec based on averaged triplicate electrocardiogram (ECG) readings at the Screening Visit using the QT interval corrected for heart rate using Fridericia's method (QTcF).
- Subjects who received a severe acute respiratory syndrome coronavirus 2 vaccine ≤3 weeks prior to study drug dosing.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (15)
15 openColorado Blood Cancer Institute
Denver, Colorado, United States
- M Tees · Contact
RecruitingFlorida Cancer Specialists
Sarasota, Florida, United States
- M Patel · Contact
RecruitingMemorial Sloan Kettering
New York, New York, United States
- Robert Stuver · Contact646-608-4308
- Robert Stuver · Principal investigator
Recruiting
12 sites outside the US
Hôpital Saint-Louis
Paris, Paris, France
- Halim Bataouche · Contact
- Adèle de Masson · Principal investigator
RecruitingThe Centre Léon Bérard
Lyon, France
- Yann Guillerman · Contact
RecruitingInstitut Paoli Calmettes
Marseille, France
- Jean Laurent L'Attention · Contact: +33 (0)4 9122 37 29
- Robin Noel · Principal investigator
RecruitingCHU de Nantes
Nantes, France
- Benoit Tessoulin · Contact
RecruitingInstitut Gustave Roussy
Villejuif, France
- Vincent Ribrag · Contact
RecruitingUniversity Hospitals of Leicester NHS Trust
Leicester, United Kingdom
- Matthew Ahearne · Contact
RecruitingImperial College / Clinical Trials Unit, Hammersmith Hospital
London, United Kingdom
- Lucy Cook · Contact0203 313 4340
RecruitingThe Christie
Manchester, United Kingdom
- Kim Linton · Contact
RecruitingNottingham City Hospital
Nottingham, United Kingdom
- Chris Fox · Contact
RecruitingChurchill Hospital
Oxford, United Kingdom
- Graham Collins · Contact
RecruitingDerriford Hospital
Plymouth, United Kingdom
- David Lewis · Contact
Recruiting- Recruiting
Study team
Sponsor
Step Pharma, SAS
Study ID STP938-101
Study director
Maureen Higgins
Step Pharma
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.