Clinical trial NCT04822298: Study of AMG 160 in Subjects With Non-Small Cell Lung Cancer
Official title: A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 160 in Subjects With Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
NSCLC
Keywords: AMG 160
Phase 1b
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2021-03-30
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the safety and tolerability of AMG 160 and to evaluate the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D).


Eligibility criteria: Inclusion Criteria:

* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* Histologically or cytologically confirmed stage 4 or recurrent non-squamous NSCLC (Part 1); histologically or cytologically. confirmed stage 4 or recurrent NSCLC (Part 2 only, squamous cell histology/cytology allowed in Part 2).
* Without a driver mutation: disease progression following at least one line of prior chemotherapy and at least 1 prior anti-programmed cell death protein 1 (PD1)/programmed death-ligand 1 (PDL1) therapy.
* With a driver mutation must experience disease progression on at least 1 targeted therapeutic agent to be eligible.
* Detectable prostate-specific membrane antigen (PSMA) expression by PSMA positron emission tomography (PET)/computed tomography (CT) imaging.
* Measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0- 2.

Exclusion Criteria:

* Radiographic evidence of intratumor cavitation, major blood vessel invasion or encasement by cancer.
* Untreated or symptomatic brain metastases and leptomeningeal disease.
* History of hemoptysis within 3 months prior to first dose.
* History or evidence of gastrointestinal inflammatory bowel disease (ulcerative colitis or Crohn disease).
* Myocardial infarction, unstable angina, cardiac arrhythmias requiring medication, and/or symptomatic congestive heart failure (New York Heart Association \> class II) within 12 months prior to start of dosing.
* Vasculitis or grade 3/4 gastrointestinal bleeding within 3 months prior to first dose; vascular disease (eg, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months of first dose.
* Gastrointestinal (GI) perforation and/or fistulae within 6 months prior to start of dosing.
* Interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with treatment.
* Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation).
* Chronic systemic corticosteroid therapy or any other immunosuppressive therapies unless stopped 7 days prior to first dose.
* Any biological therapy or immunotherapy within 3 weeks of start of first dose.
* Major surgery within 4 weeks of first dose.
* Infection requiring IV antimicrobials for management within 7 days of dosing.
* Known human immunodeficiency virus (HIV) infection, hepatitis C infection.
* Active autoimmune disease

Primary outcomes:
measure: Number of Participants Who Experience One or More Dose-limiting Toxicities (DLT)
timeFrame: Day 1 to Day 28
measure: Number of Participants Who Experience One or More Treatment-emergent AE (TEAE)
timeFrame: Median (min, max) time from first dose to 30 days after the last dose, end of study or start of new anti-cancer therapy; whichever is earlier, was 66 (52, 100) days
Secondary outcomes:
measure: Objective Response Rate (ORR) Per Modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
measure: Overall Survival (OS)
timeFrame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
measure: Radiographic Progression Free Survival (PFS) Per Modified RECIST v1.1
timeFrame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
measure: Clinical PFS Per Modified RECIST v1.1
timeFrame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
measure: Time to Response Per Modified RECIST v1.1
timeFrame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
measure: Time to Progression Per Modified RECIST v1.1
timeFrame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
measure: Time to Clinical Progression
timeFrame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
measure: Duration of Response (DOR) Per Modified RECIST v1.1
timeFrame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
measure: Time to Subsequent Therapy
timeFrame: Median (min, max) time from first dose to end of study was 100 (94, 122) days
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse
state: New South Wales
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg
city: Wien
country: Austria
facility: Universitaetsklinikum Allgemeines Krankenhaus Wien
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: