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Clinical Trial 20520

Cancer Type: Immunotherapy
Study Type: Treatment
NCT#: NCT03319940

Phase: Phase I
Principal Investigator: Chiappori, Alberto

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Study Title

A Phase 1 Study Evaluating the Safety, Tolerability and Pharmacokinetics of AMG 757 in Subjects with Small Cell Lung Cancer


This is an open-label, ascending, multiple dose, phase 1 study evaluating AMG 757 monotherapy, in combination with anti-PD1 therapy and with additional cytokine release syndrome (CRS) mitigation strategies. AMG 757 will be administered as a short term intravenous (IV) infusion in subjects with small cell lung cancer. AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)


Primary: For adult subjects with RR SCLC who progressed or recurred following platinum-based chemotherapy (Indication A) and ED SCLC with ongoing clinical benefit following no more than 6 cycles of platinum-based chemotherapy (Indication B): -Evaluate the safety and tolerability of AMG 757 -Determine the MTD or TP2D of AMG 757 Secondary: For Indications A and B: -Characterize the pharmacokinetics of AMG 757 -Evaluate preliminary anti-tumor activity of AMG 757 Exploratory: For Indications A and B: -Evaluate immunogenicity of AMG 757 -Evaluate protein, nucleic acid and cellular biomarkers in blood pre- and post AMG 757 treatment (eg cytokines, lymphocyte status, CTCs, sDLL3) -Evaluate relationship of baseline target protein expression in tumor tissue, tumor microenvironment characteristics and clinical benefit For Indication B only: -Evaluate the effects of chemotherapy and time elapsed post chemotherapy on "T cell fitness"





AMG 757 (); Pembrolizumab (Keytruda); Tarlatamab (AMG 757)

Inclusion Criteria

  • Patient has provided informed consent prior to initiation of any study-specific activities/procedures
  • Age greater than or equal to 18 years old at the time of signing the informed consent
  • Histologically or cytologically confirmed Small Cell Lung Cancer (SCLC):
  • Parts A, C, D, E, F and G: RR SCLC who progressed or recurred following at least 1 platinum based regimen;
  • Part B: ED SCLC with ongoing clinical benefit (stable disease [SD], partial response [PR], or complete response [CR]) following no more than 6 cycles of first-line platinum-based chemotherapy with the last dose of chemotherapy greater than or equal to 28 days prior to the study day 1 (first-line consolidation setting)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Subjects 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 prior to first dose of AMG 757 with exceptions
  • Major surgery within 28 days of first dose AMG 757
  • Untreated (includes new lesions or progression in previously treated lesions) or symptomatic brain metastases and leptomeningeal disease Prior anti-cancer therapy: at least 28 days must have elapsed between any prior anti-cancer therapy and first dose of AMG 757
  • Exceptions:
  • Patients who received conventional chemotherapy are eligible if at least 14 days have elapsed and if all treatment-related toxicity has been resolved to Grade less than or equal to 1
  • Prior palliative radiotherapy must have been completed at least 7 days before the first dose of AMG 757
  • Subjects who experienced severe, life-threatening or recurrent (Grade 2 or higher) immune-mediated adverse events or infusion-related reactions including those that lead to permanent discontinuation while on treatment with immune-oncology agents.
  • Has 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 AMG 757
  • Part C only: history of solid organ transplantation or active autoimmune disease that has required systemic treatment within the past 2 years
  • Participants of both genders of child bearing potential who are not willing to practice an acceptable method(s) of effective birth control while on study through 72 days for females or through 132 days for males after receiving last dose of AMG 757 and (for Part C) 4 months after receiving the last dose of pembrolizumab.
  • Additional criteria apply

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