A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
Radiopharm Theranostics, Ltd
Summary
A Phase 1/2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors
Description
The purpose of this study is to establish the safety profile, biodistribution, pharmacokinetics (pk), and radiation dosimetry of 177Lu-BetaBart, to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and to evaluate preliminary anti-tumor activity in select patient populations. 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 MTD and/or RP2D of 177Lu-BetaBart using a Bayesian Optimal Interval (BOIN) design. Phase 2a is the dose expansion phase at the RP2D to confirm th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures. 2. Participants ≥ 18 years of age. 3. Participants with a documented history of histopathologically confirmed CRPC\*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC. (Note: inclusion or exclusion criteria below marked with \* refer to CRPC only, criteria without \* refer to all tumor indications including CRPC) a. \*Progressive CRPC defined as castrate levels of testo…
Interventions
- Drug177Lu-BetaBart
BetaBart administered by intravenous (IV) infusion every 6 weeks
Locations (4)
- Dothan Hematology & OncologyDothan, Alabama
- BAMF HealthGrand Rapids, Michigan
- Nebraska Cancer SpecialistsOmaha, Nebraska
- XCancerOmaha, Nebraska