A Phase 1/2 Study of STP938 for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell
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.
| Condition(s) | Lymphoma, B-Cell, Lymphoma, T-Cell |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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 orga |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Step Pharma, SAS |
| Locations | Denver, Colorado, United States; Sarasota, Florida, United States; New York, New York, United States; Paris, Paris, France; Lyon, France; Marseille, France (+9 more sites) |
| Start date | 2022-08-03 |
| NCT ID | NCT05463263 |
| Official listing | https://clinicaltrials.gov/study/NCT05463263 |