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Study of AMG 650 in Adult Participants With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04293094
Recruitment Status : Completed
First Posted : March 3, 2020
Last Update Posted : March 9, 2023
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Description
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Brief Summary:
To evaluate the safety and tolerability of AMG 650 in adult participants and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: AMG 650 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Multicenter, Open-label, Dose-Exploration and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 650 in Subjects With Advanced Solid Tumors
Actual Study Start Date : March 11, 2020
Actual Primary Completion Date : October 24, 2022
Actual Study Completion Date : February 15, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Exploration Phase
Participants will receive AMG 650 in 1 of 3 alternative schedules. The maximum tolerated dose (MTD) of each schedule will be estimated using isotonic regression (Ji et al, 2010). The Recommended Phase 2 Dose (RP2D) may be identified based on emerging safety, efficacy, and pharmacodynamics (PD) data prior to reaching an MTD.
 Drug: AMG 650
AMG 650 administered orally as a tablet.
Experimental: Dose Expansion Phase Group 1: TNBC
Participants with locally advanced or metastatic triple negative breast cancer (TNBC), will be administered with the preliminary RP2D identified from the dose exploration part of the study.
 Drug: AMG 650
AMG 650 administered orally as a tablet.
Experimental: Dose Expansion Phase Group 2: HGSOC
Participants with locally advanced or metastatic high grade serous ovarian cancer (HGSOC), will be administered with the preliminary RP2D identified from the dose exploration part of the study.
 Drug: AMG 650
AMG 650 administered orally as a tablet.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 12 months ]
  2. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 24 months ]
  3. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 24 months ]
  4. Number of Participants with Treatment-related Adverse Events [ Time Frame: Up to 24 months ]
  5. Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurement [ Time Frame: Up to 24 months ]
  6. Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECGs) Measurement [ Time Frame: Up to 24 months ]
  7. Number of Participants Who Experience a Clinically Significant Change from Baseline in Clinical Laboratory Tests [ Time Frame: Up to 24 months ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]
  2. Duration of Response (DOR) [ Time Frame: Up to 24 months ]
  3. Progression-free Survival (PFS) [ Time Frame: Up to 24 months ]
  4. Clinical Benefit Rate (CBR) [ Time Frame: Up to 24 months ]
  5. Time to Response (TTR) [ Time Frame: Up to 24 months ]
  6. Time to Progression (TTP) [ Time Frame: Up to 24 months ]
  7. Overall Survival (OS) [ Time Frame: Up to 24 months ]
  8. Maximum Plasma Concentration (Cmax) of AMG 650 [ Time Frame: Up to 24 months ]
  9. Time to Maximum Plasma Concentration (Tmax) of AMG 650 [ Time Frame: Up to 24 months ]
  10. Area Under the Plasma Concentration-time Curve (AUC) Over the Dosing Interval for AMG 650 [ Time Frame: Up to 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and female ≥ 18 years old
  • Triple Negative Breast Cancer participants only: Participant must have histologically or cytologically confirmed metastatic or locally recurrent estrogen receptor (ER)-negative (<1% by immunohistochemistry [IHC]), progesterone receptor (PR)-negative (<1% IHC) and human epidermal growth factor receptor 2 (Her2)-negative (either fluorescent in situ hybridisation [FISH] negative, 0 or 1+ by IHC, or IHC2+ and FISH negative per ASCO/CAP definition) breast cancer. Participant must be relapsed/refractory to at least one line of systemic chemotherapy in the metastatic setting (excluding neoadjuvant or adjuvant chemotherapies) or intolerant of existing therapy(ies) known to provide clinical benefit or have no other available treatment options. Prior exposure to an immune checkpoint inhibitor is allowed.
  • Platinum-Resistant High Grade Serous Ovarian Cancer, primary peritoneal cancer and/or fallopian-tube cancer participants only: Participant must have histologically or cytologically confirmed diagnosis of metastatic or unresectable high grade serous ovarian cancer, with platinum-resistance defined as progression during or within 6 months of a platinum-containing regimen, with no other treatment option available. Prior exposure to platinum-resistant recurrence therapy is allowed.
  • Serous Endometrial Cancer participants only (Dose Exploration only): Participant must have histologically or cytologically confirmed diagnosis of metastatic or recurrent serous endometrial cancer, and be relapsed/refractory to at least one line of systemic therapy in the metastatic/recurrent setting or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.
  • Participants with advanced or metastatic solid tumor with TP53MUT (Dose Exploration only, as assessed by local testing) that is unresectable and relapsed/refractory to at least one line of systemic chemotherapy or intolerant.
  • TNBC participants only (Dose Expansion): Progressed on no more than 3 prior lines of systemic therapy for locally advanced or metastatic disease (not including adjuvant or neo-adjuvant). Systemic therapy with poly ADP ribose polymerase (PARP) inhibitor will be counted as one line of therapy.
  • HGSOC participants only (Dose Expansion): Progressed on no more than 5 prior lines of systemic therapy for locally advanced or metastatic disease (not including adjuvant or neo-adjuvant). Systemic therapy with (PARP) inhibitor will be counted as one line of therapy. Induction followed by maintenance will be counted as one line of therapy.

Exclusion Criteria:

  • Untreated or symptomatic brain metastases and leptomeningeal disease (exception: benign asymptomatic tumors are permitted).
  • Current primary CNS tumor, hematological malignancies or lymphoma.
  • Uncontrolled pleural effusions(s), pericardial effusion, or ascites.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication.
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): NCT04293094


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: NCT04293094    
Other Study ID Numbers: 20190131
First Posted: March 3, 2020    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: March 2023
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:
AMG 650
Locally-advanced/metastatic solid tumors
p53 mutation
 Serous like endometrial cancers
Triple negative breast cancer (TNBC)
High grade serous ovarian cancer (HGSOC)
Additional relevant MeSH terms:
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Neoplasms