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

Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04885998
• Other study ID #: 20200439
• Secondary ID: 2020-005957-26
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 27, 2021
• Est. completion date: January 11, 2025

Study information

• Verified date: October 2023
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 23
• Est. completion date: January 11, 2025
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Intervention

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

Locations

Country	Name	City	State
Austria	Medizinische Universitaet Innsbruck	Innsbruck
Austria	Universitaetsklinikum Allgemeines Krankenhaus Wien	Wien
Belgium	Universitair Ziekenhuis Antwerpen	Edegem
Belgium	Universitair Ziekenhuis Leuven - Campus Gasthuisberg	Leuven
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	National Cancer Center Hospital East	Kashiwa-shi	Chiba
Singapore	National Cancer Centre Singapore	Singapore
Singapore	National University Hospital	Singapore
Taiwan	Chung Shan Medical University Hospital	Taichung
Taiwan	Taipei Veterans General Hospital	Taipei
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Northwestern University, Robert H Lurie Comprehensive Cancer Center	Chicago	Illinois
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	University of Kentucky	Lexington	Kentucky
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Wake Forest Baptist Comprehensive Cancer Research Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Japan,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with a Dose Limiting Toxicity (DLT)		28 days
Primary	Number of Participants with a Treatment-emergent Adverse Event (TEAE)		24 months
Primary	Number of Participants with a Treatment-related Adverse Event		24 months
Primary	Number of Participants with a Clinically Significant Change from Baseline in Vital Signs		Baseline to Month 24
Primary	Number of Participants with a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Measurements		Baseline to Month 24
Primary	Number of Participants with a Clinically Significant Change from Baseline in Clinical Laboratory Tests		Baseline to Month 24
Secondary	Objective Response (OR) per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1		24 months
Secondary	Duration of Response (DOR)		24 months
Secondary	Disease Control Rate (DCR)		24 months
Secondary	Progression-free Survival (PFS)		24 months
Secondary	Overall Survival (OS)		24 months
Secondary	Maximum Observed Concentration (Cmax) of Tarlatamab in Combination with AMG 404		24 months
Secondary	Minimum Observed Concentration (Cmin) of Tarlatamab in Combination with AMG 404		24 months
Secondary	Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of Tarlatamab in Combination with AMG 404		24 months

External Links

•   AmgenTrials clinical trials website