Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)

NCT06598306
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
220
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Lead sponsor
Amgen
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Start date
2024-10-07
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Number of sites
31
clinicaltrials.gov

Summary
The primary objective of this study is to evaluate the safety and tolerability of subcutaneous (SC) tarlatamab.
clinicaltrials.gov
Acronym
DeLLphi-308
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Short title
Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
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Official title
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Subcutaneous Tarlatamab in Subjects With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-04-24
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First posted
2024-09-19
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Registry last updated
2026-06-26
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Primary completion date
2027-04-24
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Start date
2024-10-07
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Participants
220
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Participant count basis
Estimated
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Planned participants
220
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Protocol amendments
3
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Number of sites
31
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Amgen
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06598306
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ClinicalTrials.gov ID
NCT06598306
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Basic science
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Number of Participants with Dose-limiting toxicities (DLTs)

    Timeframe: Up to day 21

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

    Timeframe: Up to approximately 24 months

  3. Number of Participants with Changes in Vital Signs

    Timeframe: Up to approximately 24 months

  4. Number of Participants with Clinically Significant Changes in Clinical Laboratory Tests

    Timeframe: Up to approximately 24 months

  1. Maximum Serum Concentration (Cmax) of Tarlatamab

    Timeframe: Up to approximately 12 months

  2. Serum Concentration Prior to Dosing (Ctrough) of Tarlatamab

    Timeframe: Up to approximately 12 months

  3. Time to Cmax (Tmax) of Tarlatamab

    Timeframe: Up to approximately 12 months

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

    Timeframe: Up to approximately 12 months

  5. Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Timeframe: Up to approximately 24 months

  6. Duration of Response (DOR) per RECIST 1.1

    Timeframe: Up to approximately 24 months

  7. Time to Response (TTR) per RECIST 1.1

    Timeframe: Up to approximately 24 months

  8. Progression-free Survival (PFS) per RECIST 1.1

    Timeframe: Up to approximately 24 months

  9. Time to Progression per RECIST 1.1

    Timeframe: Up to approximately 24 months

  10. Time to Subsequent Therapy

    Timeframe: Up to approximately 24 months

  11. Overall Survival (OS)

    Timeframe: Up to approximately 24 months

  12. Number of Participants with Anti-tarlatamab Antibody Formation

    Timeframe: Up to approximately 24 months

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Participants ≥ 18 years of age (or ≥ legal adult age within country if it is older than 18 years) at time of signing informed consent.
  • Participants with histologically or cytologically confirmed ES-SCLC that progressed or recurred following at least one line of platinum-based anti-cancer therapy for SCLC.

Note: Participants with prior treatment for LS-SCLC should have also received another regimen for their recurrent, ES-SCLC disease.

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
  • Participants must have adequate organ function (cardiac, pulmonary, kidney, and liver).
  • Participants must be able to have SC injections administered in the abdomen.
  • Participants without measurable disease or tumor tissue (fresh biopsy or archival) available may be permitted after discussion with and approval by Amgen Medical Monitor.

  • Participants that have received prior DLL3 targeted therapy.
  • Participants with untreated or symptomatic brain metastases or those requiring therapy with steroids.
  • Note: Participants with asymptomatic brain metastatic lesions are allowed following definitive treatment (Amgen Medical Monitor may approve untreated, asymptomatic brain metastasis if local therapy is not required per investigator judgment).
  • Participants with leptomeningeal disease.
  • Participants with baseline oxygen requirement.
Sources for eligibility
clinicaltrials.gov

  • University of Southern California, Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting
  • University of Illinois ChicagoChicago, United StatesRecruiting
  • Trinity Health Saint Joseph Mercy Ann ArborAnn Arbor, United StatesRecruiting
  • Avera Cancer InstituteSioux Falls, United StatesRecruiting
  • University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting
  • Swedish Cancer InstituteSeattle, United StatesRecruiting
  • Chris OBrien LifehouseCamperdown, AustraliaRecruiting
  • Calvary Mater Newcastle HospitalWaratah, AustraliaRecruiting
  • The Alfred HospitalMelbourne, AustraliaRecruiting
  • Universitair Ziekenhuis GentGhent, BelgiumRecruiting
  • Universitair Ziekenhuis Leuven - Campus GasthuisbergLeuven, BelgiumRecruiting
  • Centre Hospitalier Universitaire de Liege - Sart TilmanLiège, BelgiumRecruiting
  • Jilin Cancer HospitalChangchun, ChinaRecruiting
  • Shanghai Pulmonary HospitalShanghai, ChinaRecruiting
  • Universitaetsklinikum RegensburgRegensburg, GermanyRecruiting
  • Universitaetsklinikum WuerzburgWürzburg, GermanyRecruiting
  • Okayama University HospitalOkayama, JapanRecruiting
  • Wakayama Medical University HospitalWakayama, JapanRecruiting
  • Uniwersyteckie Centrum KliniczneGdansk, PolandRecruiting
  • Instytut Centrum Zdrowia Matki PolkiLodz, PolandRecruiting
  • Wojewodzki Szpital im Sw Ojca Pio w PrzemysluPrzemyśl, PolandRecruiting
  • Hospital Regional Universitario de MalagaMálaga, SpainRecruiting
  • Hospital Universitari Vall d HebronBarcelona, SpainRecruiting
  • Hospital Universitari i Politecnic La FeValencia, SpainRecruiting
  • Hospital Universitario 12 de OctubreMadrid, SpainRecruiting

And 6 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Sources for references
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Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (4)