Study of AMG 650 in Adult Participants With Advanced Solid Tumors
NCT ID: NCT04293094
Last Updated: 2023-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
66 participants
INTERVENTIONAL
2020-03-11
2023-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
AMG 650
AMG 650 administered orally as a tablet.
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.
AMG 650
AMG 650 administered orally as a tablet.
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.
AMG 650
AMG 650 administered orally as a tablet.
Interventions
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AMG 650
AMG 650 administered orally as a tablet.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Volastra Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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The Angeles Clinic and Research Institute, West Los Angeles Office
Los Angeles, California, United States
Sarcoma Oncology Research Center LLC
Santa Monica, California, United States
Indiana University
Indianapolis, Indiana, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Laura and Isaac Perlmutter Cancer Center at New York University Langone
New York, New York, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Oregon Health and Science University
Portland, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Texas Oncology - Baylor
Dallas, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, , Belgium
Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
IRCCS Istituto Europeo di Oncologia
Milan, , Italy
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Countries
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Other Identifiers
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20190131
Identifier Type: -
Identifier Source: org_study_id
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