Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
- Registration Number
- NCT05800964
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to:
* Evaluate the safety and tolerability of AMG 305 in adult participants
* Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose
* Determine the recommended phase 2 dose (RP2D)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 220
- Participant has provided informed consent to the main study prior to initiation of any study specific activities/procedures
- Male or female participants age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Participants with histologically or cytologically documented selected solid tumor diseases. Participants must have exhausted available standard of care (SOC) systemic therapy or must not be candidates for such available therapy
- For dose expansion cohorts: participants with at least 1 measurable lesion ≥10 mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study
- Life expectancy > 3 months
- Adequate organ function
Key
- Untreated central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
- History of other malignancy within the past 2 years
- Ongoing or active infection (including chronic or localized)
- Any pleural effusion or pericardial effusion within 4 weeks or ascites requiring recurrent drainage procedures or other medical intervention within 2 weeks prior to the first dose of the investigational products.
- Known interstitial lung disease
- Positive test for human immunodeficiency virus (HIV)
- Positive hepatitis B surface antigen or positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR)
- History of non-infectious/immune-checkpoint inhibitor related pneumonitis that required corticosteroids, or current or suspected pneumonitis that cannot be ruled out by imaging at screening.
- Anticancer therapies including radiotherapy (with the exception of palliative radiation) chemotherapy or molecularly targeted treatments or tyrosine kinase inhibitors (TKI) within 4 weeks of administration of the first dose of AMG 305; checkpoint inhibitor therapy within 3 months of the first dose of AMG 305; or other immunotherapies/monoclonal antibodies within 3 weeks of administration of the first dose of AMG 305.
- Has had a major surgery within 4 weeks of administration of a first dose of study treatment
- Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study (eg, ulcerative colitis, Crohn's disease)
- Live and/or live-attenuated vaccines received within 28 days (or longer, if required locally) prior to the first dose of AMG 305
- Participants with unresolved toxicities from prior anti-tumor therapies to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1 or better, with the exception of alopecia and grade 2 peripheral neuropathy, which has been unchanged within the last 2 months and there is agreement to allow by both the investigator and sponsor
- Currently receiving treatment in another investigational device or drug study
- Female participants of childbearing potential or male participants unwilling to use protocol specified method of contraception
- Females who are pregnant, breastfeeding or who plan to breastfeed or become pregnant while on study
- History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A: Dose Exploration AMG 305 Participants will receive escalating doses of AMG 305. Part B: Dose Expansion AMG 305 Participants with selected solid tumors will receive the RP2D identified in Part A.
- Primary Outcome Measures
Name Time Method Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) Day 1 to Day 28 Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs) Up to a maximum of 2 years Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms (ECGs), and clinical laboratory tests, as assessed by the investigator, will also be reported as TEAEs.
Percentage of Participants who Experience Treatment-Related Adverse Events Up to a maximum of 2 years
- Secondary Outcome Measures
Name Time Method Duration of Response (DOR) Up to a maximum of 2 years DOR is defined as the time from the first documentation of objective response until the first documentation of disease progression or death due to any cause, whichever occurs first) by RECIST v1.1 and iRECIST.
Time to Progression Up to a maximum of 2 years Time to progression is defined as the time rom first AMG 305 dose until the first documentation of radiological disease progression by RECIST v1.1 and iRECIST.
Minimum Serum Concentration (Cmin) of AMG 305 Up to a maximum of 2 years Area Under the Concentration-Time Curve (AUC) of AMG 305 Up to a maximum of 2 years Progression-Free Survival (PFS) Up to a maximum of 2 years PFS is defined as the time from first AMG 305 dose until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first) by RECIST v1.1 and iRECIST.
Overall Survival (OS) at 1 Year 1 year Maximum Serum Concentration (Cmax) of AMG 305 Up to a maximum of 2 years Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Up to a maximum of 2 years ORR is defined as best overall response (BOR) of complete response (CR) or partial response (PR), Clinical Benefit Rate (defined as BOR of CR, PR, or stable disease \[SD\] with duration of 24 weeks or longer) based on RECIST v1.1.
OS at 2 Years 2 years ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST) Up to a maximum of 2 years ORR is defined as immune best overall response (iBOR) of immune complete response (iCR) or immune partial response (iPR), Clinical Benefit Rate (defined as iBOR of iCR, iPR, or immune stable disease \[iSD\] with duration of 24 weeks or longer) based on iRECIST.
Trial Locations
- Locations (26)
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
New York University Cancer Institute
🇺🇸New York, New York, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Next Oncology
🇺🇸San Antonio, Texas, United States
Chris OBrien Lifehouse
🇦🇺Camperdown, New South Wales, Australia
Peter MacCallum Cancer Centre
🇦🇺Melbourne, Victoria, Australia
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Institut Universitaire du Cancer Toulouse Oncopole
🇫🇷Toulouse cedex 9, France
Gustave Roussy
🇫🇷Villejuif, France
Universitaetsklinikum Dresden
🇩🇪Dresden, Germany
Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Hospital Universitari Vall d Hebron
🇪🇸Barcelona, Cataluña, Spain
Hospital Clinic i Provincial de Barcelona
🇪🇸Barcelona, Cataluña, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Madrid Sanchinarro
🇪🇸Madrid, Spain
Sarah Cannon Research Institute UK
🇬🇧London, United Kingdom
Christie Hospital
🇬🇧Manchester, United Kingdom
Freeman Hospital
🇬🇧Newcastle, United Kingdom
Royal Marsden Hospital
🇬🇧Sutton, United Kingdom