Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors

NCT05800964 | Completed Phase 1 FDA Drug

• 2 other identifiers: 202200732022-502867-39
• Study Type: interventional
• Target: 37
• Locations: 9 countries
• Sites: 27

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)

Conditions

Advanced Solid Tumors

Keywords

Safety; Tolerability; Pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants who Experience Dose Limiting Toxicities (DLTs)

  Day 1 to Day 28

• Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs)

  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.

  Up to a maximum of 2 years

• Percentage of Participants who Experience Treatment-Related Adverse Events

  Up to a maximum of 2 years

Secondary Outcomes (10)

• Maximum Serum Concentration (Cmax) of AMG 305

  Up to a maximum of 2 years

• 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

• 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 based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST)

  Up to a maximum of 2 years

Study Arms (2)

Part A: Dose Exploration

EXPERIMENTAL

Participants will receive escalating doses of AMG 305.

Drug: AMG 305

Part B: Dose Expansion

EXPERIMENTAL

Participants with selected solid tumors will receive the RP2D identified in Part A.

Drug: AMG 305

Interventions

AMG 305 DRUG

Short-term intravenous (IV) infusion

Part A: Dose Exploration; Part B: Dose Expansion

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (27)

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

New York University Cancer Institute

New York, New York, 10016, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Next Oncology

San Antonio, Texas, 78229, United States

Location

Chris OBrien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2C1, Canada

Location

Institut Universitaire du Cancer Toulouse Oncopole

Toulouse, 31059, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Universitaetsklinikum Dresden

Dresden, 01307, Germany

Location

Universitaetsklinikum Essen

Essen, 45147, Germany

Location

Universitaetsklinikum Wuerzburg

Würzburg, 97078, Germany

Location

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hospital Universitari Vall d Hebron

Barcelona, Catalonia, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, Catalonia, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Madrid Sanchinarro

Madrid, 28050, Spain

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Sarah Cannon Research Institute UK

London, W1G 6AD, United Kingdom

Location

University College London Hospital

London, W1T 7HA, United Kingdom

Location

Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

Freeman Hospital

Newcastle, NE7 7DN, United Kingdom

Location

Royal Marsden Hospital

Sutton, SM2 5PT, United Kingdom

Location

Related Links

• AmgenTrials clinical trials website

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: June 13, 2023
• Primary Completion: January 22, 2026
• Study Completion: January 22, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

AU (2); ES (4); CA (1); FR (2); JP (1); GB (6); KR (2); US (6); DE (3)