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

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ClinicalTrials.gov Identifier: NCT05800964
Recruitment Status : Recruiting
First Posted : April 6, 2023
Last Update Posted : May 9, 2024
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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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)

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: AMG 305 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 305 in Subjects With Advanced Solid Tumors
Actual Study Start Date : June 13, 2023
Estimated Primary Completion Date : May 13, 2026
Estimated Study Completion Date : January 14, 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: Dose Exploration
Participants will receive escalating doses of AMG 305.
 Drug: AMG 305
Short-term intravenous (IV) infusion
Experimental: Part B: Dose Expansion
Participants with non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic cancer, and other solid tumors will receive the RP2D identified in Part A.
 Drug: AMG 305
Short-term intravenous (IV) infusion


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants who Experience Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 to Day 28 ]
  2. Percentage of Participants who Experience Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: 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.

  3. Percentage of Participants who Experience Treatment-Related Adverse Events [ Time Frame: Up to a maximum of 2 years ]

Secondary Outcome Measures :
  1. Maximum Serum Concentration (Cmax) of AMG 305 [ Time Frame: Up to a maximum of 2 years ]
  2. Minimum Serum Concentration (Cmin) of AMG 305 [ Time Frame: Up to a maximum of 2 years ]
  3. Area Under the Concentration-Time Curve (AUC) of AMG 305 [ Time Frame: Up to a maximum of 2 years ]
  4. Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) [ Time Frame: 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.

  5. ORR based on Immune Response Evaluation Criteria in Solid Tumors (iRECIST) [ Time Frame: 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.

  6. Duration of Response (DOR) [ Time Frame: 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.

  7. Time to Progression [ Time Frame: 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.

  8. Progression-Free Survival (PFS) [ Time Frame: 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.

  9. Overall Survival (OS) at 1 Year [ Time Frame: 1 year ]
  10. OS at 2 Years [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

Pre-screening:

  • Participant has provided informed consent prior to initiation of any pre screening study specific activities/procedures.
  • Participants with histologically or cytologically documented solid tumor diseases expressing cadherin-3 and mesothelin (by mRNA in the Cancer Genome Atlas Program [TCGA] database), including CRC, NSCLC, mesothelioma, pancreatic cancer, gastric cancer, head and neck cancer, cervical carcinoma, uterine carcinoma, and breast cancer

Clinical study:

  • Participant has provided inform 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 solid tumor diseases, including CRC, NSCLC, mesothelioma, pancreatic cancer, GC, head and neck cancer, cervical carcinoma, uterine carcinoma, and breast cancer. 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 Exclusion Criteria:

  • 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
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • 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)
  • Anticancer therapies including radiotherapy (with the exception of palliative radiation) chemotherapy or molecularly targeted treatments or tyrosine kinase inhibitors (TKI) within 4 weeks or 5 half lives (whichever is longer) of administration of a first dose of study treatment; immunotherapies/monoclonal antibodies within 3 weeks of administration of a first dose of study treatment.
  • 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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05800964


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
More Information
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Additional Information:

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT05800964    
Other Study ID Numbers: 20220073
2022-502867-39 ( EudraCT Number )
First Posted: April 6, 2023    Key Record Dates
Last Update Posted: May 9, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: http://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
Safety
Tolerability
Pharmacokinetics
Additional relevant MeSH terms:
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Neoplasms