Breast Cancer Clinical Trial

Study of AMG 650 in Adult Participants With Advanced Solid Tumors

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).

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT04293094

Recruitment Status:

Active, not recruiting

Sponsor:

Amgen

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There are 21 Locations for this study

See Locations Near You

The Angeles Clinic and Research Institute, West Los Angeles Office
Los Angeles California, 90025, United States
Sarcoma Oncology Research Center LLC
Santa Monica California, 90403, United States
Indiana University
Indianapolis Indiana, 46202, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Washington University
Saint Louis Missouri, 63110, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Laura and Isaac Perlmutter Cancer Center at New York University Langone
New York New York, 10016, United States
Wake Forest University School of Medicine
Winston-Salem North Carolina, 27157, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Texas Oncology - Baylor
Dallas Texas, 75246, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
The Queen Elizabeth Hospital
Woodville South South Australia, 5011, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven , 3000, Belgium
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 1, Canada
IRCCS Istituto Europeo di Oncologia
Milano , 20141, Italy
Aichi Cancer Center
Nagoya-shi Aichi, 464-8, Japan
National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan
Hospital General Universitario Gregorio Marañon
Madrid , 28009, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

140

Study ID:

NCT04293094

Recruitment Status:

Active, not recruiting

Sponsor:


Amgen

How clear is this clinincal trial information?

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