Tarlatamab in Advanced DLL3-Expressing Tumors Including Neuroendocrine Neoplasms
Jonsson Comprehensive Cancer Center
Summary
This study is being done to learn more about the drug tarlatamab in people with your condition. The purpose of this study is to see the efficacy (how well something works) of study treatment (tarlatamab) and whether it causes any side effects. Tarlatamab is being developed as an anti-cancer drug for tumors and is FDA-approved for extensive-stage small cell lung cancer. Tarlatamab is investigational for the purpose of this study.
Description
This is a phase II, multicenter, basket trial to evaluate the safety, tolerability, and efficacy of tarlatamab in DLL3-expressing tumors. The study will enroll patients with advanced tumors, other than small cell lung cancer or neuroendocrine prostate cancer, that are confirmed to exhibit DLL3 expression. Patients will be treated with tarlatamab until disease progression, death, unacceptable adverse effects, or withdrawal of consent. A Simon's two-stage optimum design will be used \[1\]. The primary objective of this phase II trial is the overall response rate (ORR, as defined by confirmed co…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participant has provided informed consent prior to initiation of any study specific activities/procedures. 2. Male or female ≥ 18 years of age and willing and able to provide informed consent. 3. Histologically or cytologically confirmed malignancy other than de novo (i.e., non-transformed) SCLC or NEPC. Must be stage IV (metastatic); participants with stage III disease are eligible provided that they are not candidates for surgery and/or radiotherapy with curative intent…
Interventions
- DrugTarlatamab treatment
* 1 mg step dose on cycle 1 day 1 (C1D1) * 10 mg target dose on cycle 1 day 8 (C1D8), and cycle 1 day 15 (C1D15) in a 28-day cycle. * 10 mg Q2W subsequently (i.e., C2 + D1/D15 dosing) in a 28-day cycle
Locations (5)
- UC Davis Comprehensive Cancer CenterDavis, California
- UCI Health Chao Family Comprehensive Cancer CenterIrvine, California
- University of California at Los AngelesLos Angeles, California
- UC San Diego Moores Cancer CenterSan Diego, California
- University of California at San FranciscoSan Francisco, California