Study of AMG 650 in Adult Participants With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Apr 19, 2024
  • participants needed
    140
  • sponsor
    Amgen
Updated on 23 July 2021

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).

Details
Condition Advanced Solid Tumors
Treatment AMG 650
Clinical Study IdentifierNCT04293094
SponsorAmgen
Last Modified on23 July 2021

Eligibility

Yes No Not Sure

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 or intolerant of existing therapy(ies) known to provide clinical benefit for their condition. 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. 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

Exclusion Criteria

Active brain metastases
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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