Radiopharm Theranostics, Ltd
This is a Phase 1/2a dose escalation and expansion study to determine the safety, tolerability, and preliminary clinical activity of 177LuBetaBart, a lutetium-labeled anti-B7-H3 monoclonal antibody, in patients with relapsed/refractory, locally advanced inoperable, or metastatic solid tumors
The main objectives of the study are to establish the safety, recommended Phase 2 dose (RP2D), pharmacokinetics (pk), and preliminary anti-tumour activity of 177Lu-BetaBart, a lutetium-labeled anti-B7-H3 monoclonal antibody, in patients with solid tumors who may benefit from this treatment and who meet the study eligibility criteria. The study is divided into 2 phases. Phase 1 is the dose escalation phase to establish the safety profile of 177Lu-BetaBart and to determine the maximum tolerated dose (MTD) and/or RP2D of 177Lu-BetaBart. Phase 2a is the dose expansion phase to evaluate prelimina…
1. Participants ≥ 18 years of age. 2. Participants with a documented history of histopathologically confirmed CRPC\*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC. a. \*Progressive CRPC defined by at least one of the following criteria: i. Two consecutive increases in PSA measured at least 1 week apart. ii. Soft tissue progression defined as a ≥20% increase in the sum of the diameter or the appearance of one or more new lesions by computed tomography (CT)/magnetic resonance imaging (MRI). iii. Progression of bone disease defined by Prostat…
177Lu-BetaBart administered intravenously (IV) every 6 weeks at escalating doses
177Lu-BetaBart + unlabeled BetaBart administered intravenously (IV) every 6 weeks at escalating doses