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A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

ConditionExtensive Stage Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorAmgen

About this trial

The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.

The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant has provided informed consent before initiation of any study-specific activities/procedures.

Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.

Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC.

Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.

Disqualifiers

Symptomatic central nervous system (CNS) metastases.

Participants with brain metastases may be eligible if criteria defined in the protocol are met.

Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).

Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Tarlatamab

    Drug

    Administered as an IV infusion.

  • AB248

    Drug

    Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.

Treatment groups

380 Participants
are divided into 2 treatment groups
Group A: Dose ExplorationExperimental treatment 2 interventions
Group B: Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment-emergent Adverse Events (TEAEs)

Clinically significant changes in vital signs and clinical laboratory tests will be reported as adverse events.

Time frame
Up to 2.5 years
2

Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)

Time frame
Up to 35 days

Secondary outcomes

1

Maximum Serum Concentration (Cmax) of Tarlatamab

Time frame
Up to approximately 21 weeks
2

Minimum Serum Concentration (Cmin) of Tarlatamab

Time frame
Up to approximately 21 weeks
3

Area Under the Concentration-time Curve (AUC) of Tarlatamab

Time frame
Up to approximately 21 weeks
4

Half-life (t1/2) of Tarlatamab

Time frame
Up to approximately 21 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amgen

Lead sponsor

Asher Biotherapeutics, Inc.

Collaborator

Source ClinicalTrials.gov
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