Study on Tarlatamab for Advanced Tumors with DLL3 Expression, Including Neuroendocrine Tumors
Sponsor: Jonsson Comprehensive Cancer Center
ClinicalTrials ID:NCT06788938
This clinical trial is testing the drug tarlatamab to see how well it works and if it causes any side effects in people with advanced tumors that express DLL3, a specific protein. Tarlatamab is already approved for certain lung cancers but is being studied for other types of tumors in this trial.
Patient Parameters
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Program Overview
The study aims to evaluate the effectiveness and safety of tarlatamab in patients with advanced tumors that show DLL3 expression. It will include patients with various types of neuroendocrine tumors, excluding small cell lung cancer and neuroendocrine prostate cancer. Participants will receive tarlatamab until their disease progresses, they experience unacceptable side effects, or they choose to stop treatment. The study will use a specific design to determine how many patients respond to the treatment.
Description
This phase II trial is being conducted at multiple centers to assess the safety and effectiveness of tarlatamab in patients with DLL3-expressing tumors. The trial will include patients with advanced tumors, such as certain neuroendocrine tumors, that are not small cell lung cancer or neuroendocrine prostate cancer. Participants will continue treatment with tarlatamab until their cancer worsens, they experience severe side effects, or they decide to withdraw from the study.
The study will use a two-stage design to evaluate the overall response rate, which measures how many patients have a significant reduction in tumor size. Initially, 10 patients will be enrolled, and if at least 2 show a response, an additional 19 patients will be included. If 6 or more out of 29 patients respond, the study will consider the treatment effective.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent before starting any study-related activities.
- Must be 18 years or older and able to consent.
- Must have a confirmed diagnosis of an advanced tumor that is not small cell lung cancer or neuroendocrine prostate cancer.
- Tumors must show DLL3 expression, with at least 25% for initial participants and 1% for later participants.
- Must have tried at least one previous treatment if a standard option exists.
- Must have measurable disease according to specific criteria.
- Must have a performance status indicating they are fully active or have some restrictions but can still perform light work.
- Must have adequate organ function based on specific blood tests.
Exclusion Criteria
- Cannot have small cell lung cancer (unless it transformed from another type) or neuroendocrine prostate cancer.
- Tumors must be evaluable for DLL3 expression and show at least 1% expression.
- Cannot have untreated or worsening brain metastases, except if treated and stable.
- Cannot have certain lung diseases unless stable and related to past radiation.
- Cannot be enrolled in another clinical study unless in follow-up or observational phase.
- Cannot have received certain cancer treatments recently.
- Cannot have had prior treatment targeting the DLL3 pathway.
- Cannot have had severe reactions to immune therapies.
- Cannot be on high-dose steroids or other immune-suppressing drugs recently.
- Cannot have had major surgery recently.
- Cannot have had recent live vaccinations.
- Cannot have had another cancer in the past 2 years, with some exceptions.
- Cannot have recent heart issues or strokes.
- Cannot have active HIV, hepatitis B, or hepatitis C infections unless controlled.
- Cannot have active infections or other serious medical conditions.
- Women must not be pregnant or breastfeeding and must use contraception.
- Men must use contraception if their partner is of childbearing potential.
- Cannot have allergies to study drugs.
- Must be able to attend all study visits and follow procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UC Davis Comprehensive Cancer Center | 95817 | Davis | California |
| UCI Health Chao Family Comprehensive Cancer Center | 92612 | Irvine | California |
| University of California at Los Angeles | 90095 | Los Angeles | California |
| UC San Diego Moores Cancer Center | 92093 | San Diego | California |
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