AMG 757 and AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)

Sponsor
Amgen (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04885998
Collaborator
(none)
50
14
2
51.6
3.6
0.1

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety, tolerability, and recommended phase 2 target dose of tarlatamab in combination with AMG 404.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b Study Evaluating the Safety and Efficacy of AMG 757 in Combination With AMG 404 in Subjects With Small Cell Lung Cancer (SCLC)
Actual Study Start Date :
Sep 27, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 16, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase 1: Dose Exploration

The recommended phase 2 target dose (RP2D) of tarlatamab in combination with AMG 404 will be estimated using a modified toxicity probability interval (mTPI-2) design. A combination RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an maximum tolerated dose (MTD).

Drug: Tarlatamab
Tarlatamab will be administered as an intravenous (IV) infusion.
Other Names:
  • AMG 757
  • Drug: AMG 404
    AMG 404 will be administered as an intravenous (IV) infusion.

    Experimental: Phase 2: Dose Expansion

    Participants will receive the RP2D of tarlatamab in combination with AMG 404 identified in Phase 1 (dose exploration) of the study.

    Drug: Tarlatamab
    Tarlatamab will be administered as an intravenous (IV) infusion.
    Other Names:
  • AMG 757
  • Drug: AMG 404
    AMG 404 will be administered as an intravenous (IV) infusion.

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with a Dose Limiting Toxicity (DLT) [28 days]

    2. Number of Participants with a Treatment-emergent Adverse Event (TEAE) [24 months]

    3. Number of Participants with a Treatment-related Adverse Event [24 months]

    4. Number of Participants with a Clinically Significant Change from Baseline in Vital Signs [Baseline to Month 24]

    5. Number of Participants with a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements [Baseline to Month 24]

    6. Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests [Baseline to Month 24]

    Secondary Outcome Measures

    1. Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [24 months]

    2. Duration of Response (DOR) [24 months]

    3. Disease Control Rate (DCR) [24 months]

    4. Progression-free Survival (PFS) [24 months]

    5. Overall Survival (OS) [24 months]

    6. Maximum Observed Concentration (Cmax) of Tarlatamab in Combination with AMG 404 [24 months]

    7. Minimum Observed Concentration (Cmin) of Tarlatamab in Combination with AMG 404 [24 months]

    8. Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab in Combination with AMG 404 [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures

    • Age greater than or equal to 18 years old at the same time of signing the informed consent

    • Participants with histologically or cytologically confirmed Small Cell Lung Cancer (SCLC) who progressed or recurred following at least 1 platinum-based regimen

    • Eastern Cooperative Oncology Group (ECOG) 0 to 1

    • Participants with treated brain metastases are eligible provided they meet defined criteria

    • Adequate organ function as defined in protocol

    Exclusion Criteria:
    • History of other malignancy within the past 2 years with exceptions

    • Major surgery within 28 days of first dose of tarlatamab

    • Untreated or symptomatic brain metastases and leptomeningeal disease

    • Prior anti-cancer therapy, including anti-PD1 or anti-PDL1 antibody therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and the first planned dose of tarlatamab

    Exceptions:
    • Participants who received prior chemotherapy must have completed at least 14 days before the first dose of tarlatamab and all treatment-related toxicity resolved to grade ≤ 1.

    • Participants who received prior palliative radiotherapy must have completed at least 7 days before the first dose of tarlatamab

    • Participants who received prior tarlatamab therapy or prior delta-like ligand 3 (DLL3) x cluster of differentiation 3 (CD3) bispecific therapy are not eligible

    • Participants who experienced recurrent grade 2 pneumonitis or severe or life-threatening immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immuno-oncology agents

    • History of any immune-related colitis. Infectious colitis is allowed if evidence of adequate treatment and clinical recovery exists and at least 3 months interval observed since diagnosis of colitis

    • Participants with evidence of interstitial lung disease or active, non-infectious pneumonitis

    • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of tarlatamab

    • History of solid organ transplantation

    • History of hypophysitis or pituitary dysfunction

    • Active autoimmune disease that has required systemic treatment (except replacement therapy) within the past 2 years or any other diseases requiring immunosuppressive therapy while on study. Participants with Type I diabetes, vitiligo, psoriasis, hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are permitted

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University, Robert H Lurie Comprehensive Cancer Center Chicago Illinois United States 60611
    2 University of Kentucky Lexington Kentucky United States 40536
    3 Wake Forest Baptist Comprehensive Cancer Research Center Winston-Salem North Carolina United States 27157
    4 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106
    5 Medical University of South Carolina Charleston South Carolina United States 29425
    6 Tennessee Oncology, PLLC Nashville Tennessee United States 37203
    7 Huntsman Cancer Institute Salt Lake City Utah United States 84112
    8 Medizinische Universitaet Innsbruck Innsbruck Austria 6020
    9 Universitaetsklinikum Allgemeines Krankenhaus Wien Wien Austria 1090
    10 Universitair Ziekenhuis Antwerpen Edegem Belgium 2650
    11 Universitair Ziekenhuis Leuven - Campus Gasthuisberg Leuven Belgium 3000
    12 National Cancer Center Hospital East Kashiwa-shi Chiba Japan 277-8577
    13 Chung Shan Medical University Hospital Taichung Taiwan 40201
    14 Taipei Veterans General Hospital Taipei Taiwan 11217

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT04885998
    Other Study ID Numbers:
    • 20200439
    • 2020-005957-26
    First Posted:
    May 13, 2021
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amgen
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2022