MT-3724

Two patients experienced grade 2 capillary leak syndrome (CLS). Combination therapy with MT-3724 and GEMOX demonstrated an early efficacy signal but was limited by the incidence of CLS.

Clinical activity was seen in heavily pre-treated hematological malignancies with a first-generation ETB (MT-3724) targeting CD20...Prior treatment with an anti-CD38 therapy (including daratumumab) is permitted...The trial is currently recruiting at three US sites. (NCT04017130)

P2, N=8, Terminated, Molecular Templates, Inc. | N=64 --> 8 | Trial completion date: Feb 2023 --> Mar 2021 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Mar 2021; Sponsor decision

P2, N=64, Active, not recruiting, Molecular Templates, Inc. | Recruiting --> Active, not recruiting

Subjects with CNS involvement or recent treatment with rituximab (within 84 days of study initiation; if received within 12-37 weeks of start of treatment, serum rituximab level must be confirmed to be negative [<500 ng/mL]), obinutuzumab (within 184 days), or ofatumumab (within 88 days) will be excluded. A Bayesian optimal interval design will be used to identify the RP2D more accurately (target toxicity rate φ=0.3). Enrollment is anticipated to begin in December 2020.

Subjects with Grade 3b FL, central nervous system or leptomeningeal involvement, or recent treatment with rituximab (within 84 days of study initiation; if received within 12-37 weeks of start of treatment, serum rituximab level must be confirmed to be negative [<500 ng/mL]), obinutuzumab (within 184 days), or ofatumumab (within 88 days) are not eligible. Development of and timing of DLTs will be used to identify the RP2D for Part 2, which will comprise a dose expansion cohort. Enrollment is anticipated to initiate in December 2020 globally.

P2, N=64, Recruiting, Molecular Templates, Inc. | Trial completion date: Feb 2022 --> Feb 2023 | Trial primary completion date: Jul 2020 --> Dec 2022