Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors

  • STATUS
    Recruiting
  • End date
    Apr 30, 2025
  • participants needed
    60
  • sponsor
    Debiopharm International SA
Updated on 6 June 2022

Summary

The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of Debio 0123 when administered in combination with carboplatin in participants with advanced solid tumors that recurred or progressed after prior cisplatin or carboplatin containing therapy and for which no standard therapy of proven benefit is available.

Details
Condition Advanced Solid Tumors
Treatment carboplatin, Debio 0123
Clinical Study IdentifierNCT03968653
SponsorDebiopharm International SA
Last Modified on6 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed locally advanced or metastatic solid and nonbleeding tumors that had recurred or progressed following standard therapy, has not responded to standard therapy or for which no standard therapy of proven benefit is available
Able and willing to undergo tumor biopsy
Prior platinum-based therapy (carboplatin or cisplatin)
Life expectancy of at least 3 months
ECOG performance score 0-1

Exclusion Criteria

History of other malignancies requiring active treatment in the last 6 months
Brain tumors and/or symptomatic brain metastases
Receiving other investigating agents
Presence of significant cardiovascular disease or other co-morbidities such as symptomatic ascites
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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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