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Bi-specific T-Cell Engager

Tarlatamab + Radiation for Cancer (RABBIT Trial)

Tucson, AZ

Phase 1 & 2

Waitlist Available

Led By Charles Hsu, MD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be ≥ 18 years of age at the time of signing the informed consent

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Must not have

Unresolved toxicity from prior anti-tumor therapy not resolved to grade ≤ 1

Subjects with no lesion(s)/site(s) amenable to radiation therapy, planned re-irradiation of a previously irradiated site, leptomeningeal disease requiring craniospinal irradiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until radiographic or disease progression or up to 24 months, whichever is earlier.

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at the safety of adding a drug called tarlatamab to standard radiation therapy for patients with cancer. The study will first include 20-24 patients with cancer outside the brain

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Who is the study for?

This trial is for patients with various cancers, including lung, skin, and bladder cancer. Participants must have tumors expressing DLL3 and be suitable for radiation therapy. Specific eligibility criteria are not provided but typically include factors like age, health status, and prior treatments.Check my eligibility

What is being tested?

The study tests Tarlatamab combined with standard radiation therapy (RT), either given at the same time or sequentially. It starts with extracranial sites and may expand to cranial sites if safe. The goal is to assess safety first then efficacy, especially in non-small cell lung cancer types.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical ones from similar therapies include fatigue, skin reactions from RT, immune-related effects from Tarlatamab such as inflammation or infusion reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than 50% of my waking hours.

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I can have radiation therapy on a cancer spot that hasn't been treated with radiation before.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I still have significant side effects from previous cancer treatments.

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I cannot have radiation therapy due to my condition or previous treatments.

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I have lung scarring or inflammation not caused by an infection.

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I had severe reactions to previous immune therapy.

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I do not have recent major surgery, heart issues, serious infections, lung disease, autoimmune disease, or HIV.

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I haven't had tarlatamab, cancer treatment in the last 30 days, or recent steroids/immunosuppressants.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until radiographic or disease progression or up to 24 months, whichever is earlier.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until radiographic or disease progression or up to 24 months, whichever is earlier.

This trial's timeline: 3 weeks for screening, Varies for treatment, and until radiographic or disease progression or up to 24 months, whichever is earlier. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of participants experiencing dose limiting toxicities (DLT) attributed to radiation or combination of radiation and tarlatamab.

Secondary study objectives

Duration or Response (DOR)

Objective response rate (ORR) using RESIST/iRECIST and RANO/RANO-BM criteria of radiated and non-radiated sites stratified by anatomic RT site and tumor histology.

Overall survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Tarlatamab Monotherapy CohortExperimental Treatment1 Intervention

If the sequential safety endpoint is not met, then the study will proceed to another de-escalation phase, where 10 patients will receive tarlatamab alone.

Group II: Sequential radiation therapy cohortExperimental Treatment2 Interventions

If the concurrent main cohort safety endpoint is not met, then the study will proceed to de-escalation, where 20 patients will be enrolled on the sequential radiation therapy cohort. In this cohort patients will receive sequential tarlatamab and RT to cranial and extracranial RT sites. Standard of care RT can occur prior to Cycle 1 Day 1(if radiation treatment is completed \<7 days prior to the start of tarlatamab) or be interdigitated with tarlatamab with a 7-day washout between RT and infusion, with RT to begin as early as Cycle 1 Day 22 and as late as cycle 2 Day 28, assuming no ongoing CRS/ICANS.

Group III: Concurrent Main CohortExperimental Treatment2 Interventions

Patients enrolled to this cohort will receive tarlatamab with concurrent radiation therapy (RT) to extracranial sites (n=20-24 extracranial RT with a minimum of 10 thoracic patients). Patients will receive tarlatamab at a step-up dose of 1 mg on Cycle 1 Day 1 and then 10 mg on cycle 1 Day 8 and Cycle 1 Day 15 and every 2 weeks thereafter (on days 1 and 15 of each cycle) until radiographic progression or disease progression or 24 months, whichever is earlier. Patients will receive concurrent RT to extracranial sites as per standard of care starting as early as Cycle 1 Day 16 and as late as Cycle 2 Day 28, assuming there is no ongoing cytokine release syndrome (CRS) or immune-effector cell-associated neurotoxicity Syndrome (ICANS).

Group IV: Concurrent Cranial CohortExperimental Treatment2 Interventions

If the safety endpoint in the Concurrent Main Cohort is met, enrollment will expand to the Concurrent Cranial Cohort. 6-10 patients will receive tarlatamab with concurrent radiation therapy to cranial sites as described in the Concurrent Main Cohort.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tarlatamab

2021

Completed Phase 1

~70

0 / 9Eligibility criteria met