A Phase 1/2, First-in-Human, Open-Label, Multicenter Study of TORL-5-700 as a Monotherapy and in Combination for Participants With Relapsed or Refractory Non-Hodgkin Lymphoma
TORL Biotherapeutics, LLC
Summary
A Phase 1/2 study to evaluate safety, tolerability, and anticancer activity of TORL-5-700 as a monotherapy and in combination in R/R NHL
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Confirmed B-NHL, including but not limited to de novo DLBCL; FL, Grades 1 to 3A; MCL; transformed lymphoma (tFL, RT) and FL Grade 3B; MZL and MALT. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * At least 1 measurable lesion per Lugano criteria. * Tumor tissue is available. * Adequate organ function Exclusion Criteria: * T-cell lymphoma * CLL or SL * Burkitt lymphoma and high-grade B-cell lymphoma * CNS involvement * Peripheral neuropathy \> Grade 2 * Uncontrolled medical conditions * Viral infections
Interventions
- DrugTORL-5-700
Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks
- DrugTORL-5-700 at MTD/RP2D
Part 2: Monotherapy Expansion - TORL-5-700 at Maximum tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) Administered once every three weeks
- DrugTORL-5-700 at MTD/RP2D in combination with another agent
Part 3: Combination Evaluation - TORL-5-700 at MTD/RP2D administered every three weeks in combination with another agent
Locations (3)
- UCLASanta Monica, California
- Stanford UniversityStanford, California
- Sarah Cannon Research InstituteNashville, Tennessee