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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Main Inclusion Criteria:
* 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.
Main Exclusion Criteria:
* 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.
Primary outcome measure(s)
Safety and Tolerability (Phase 1 / Dose Escalation) — Through study completion, an average of 9 months Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)
Objective Response Rate (ORR) (Phase 2 / Dose Expansion) — Through study completion, an average of 9 months 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
Trial sites (15)
Facility
City
Region
Status
Colorado Blood Cancer Institute
Denver
Colorado
Recruiting
Florida Cancer Specialists
Sarasota
Florida
Recruiting
Memorial Sloan Kettering
New York
New York
Recruiting
Hôpital Saint-Louis
Paris
Paris
Recruiting
The Centre Léon Bérard
Lyon
France
Recruiting
Institut Paoli Calmettes
Marseille
France
Recruiting
CHU de Nantes
Nantes
France
Recruiting
Institut Gustave Roussy
Villejuif
France
Recruiting
University Hospitals of Leicester NHS Trust
Leicester
United Kingdom
Recruiting
Imperial College / Clinical Trials Unit, Hammersmith Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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