Study of AMG 650 in Adult Participants With Advanced Solid Tumors

  • STATUS
    Recruiting
  • participants needed
    120
  • sponsor
    Amgen
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Updated on 19 February 2024
See if I qualify

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
Age 18years - 99years
Treatment AMG 650
Clinical Study IdentifierNCT04293094
SponsorAmgen
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male and female 18 years old
Triple Negative Breast Cancer: Participant must have histologically or cytologically confirmed metastatic or locally recurrent ER-negative (<1% by IHC), PR-negative and Her2-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: 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: 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
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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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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