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

Study Purpose

This study has two parts: Dose Escalation and Dose Expansion. The primary objective of the study, in the Dose Escalation Part 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. The primary objective of the study, in the Dose Expansion Part is to characterize the safety and tolerability of Debio 0123 when administered in combination with carboplatin at the RP2D determined during the dose escalation part of the study and to evaluate the preliminary antitumor activity of Debio 0123 when administered in combination with carboplatin.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Dose Escalation:
  • - 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 PS 0-1.
Dose Expansion:
  • - Histologically or cytologically confirmed, recurrent solid tumors of selected types.
  • - Participants must have progressed after at least 1 prior platinum-based line of therapy for advanced/metastatic disease.
  • - Participants must be platinum resistant (defined as progression within 6 months of completion of their most recent platinum-based chemotherapy).
Prior poly (ADP-ribose) polymerase (PARP) inhibitor therapy is allowed. Platinum-based therapy does not need to be the last treatment prior to study entry.
  • - Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • - Documented progressive or recurrent disease according to RECIST 1.1 since the last anti-cancer therapy and prior to study entry.
  • - Able and willing to undergo tumor biopsy.
  • - ECOG PS 0-1.
  • - Life expectancy of at least 3 months.

Exclusion Criteria:

Dose Escalation and Dose Expansion:
  • - 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.
- Prior exposure to any WEE1 inhibitor

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03968653
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Debiopharm International SA
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Netherlands, Spain
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Advanced Solid Tumors
Arms & Interventions

Arms

Experimental: Dose Escalation: Group A: Debio 0123

Participants will receive Debio 0123 as monotherapy (Day -3), orally, daily for 3 days during Cycle 1 then in combination with carboplatin intravenous infusion from Cycle 2 onwards. Depending on pharmacokinetics (PK) and safety results from previous cohorts, the Debio 0123 dosing regimen may be modified for subsequent cohorts.

Experimental: Dose Escalation: Group B: Debio 0123

Participants will receive Debio 0123, orally, daily, for 6 days during each cycle in combination with carboplatin IV infusion.

Experimental: Dose Expansion: Debio 0123

Participants with platinum-resistant selected solid tumors will receive Debio 0123, orally, daily, depending on the RP2D determined in the previous part, for 3 or 6 days during each cycle in combination with carboplatin IV infusion.

Interventions

Drug: - Debio 0123

Debio 0123 will be given as an oral capsule for 3 days during each 21-day cycle, except Cycle 1 which is of 24 days.

Drug: - Carboplatin

Carboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 2 onwards in Group A.

Drug: - Debio 0123

Debio 0123 will be given as an oral capsule for 3 or 6 days during each 21-day cycle.

Drug: - Carboplatin

Carboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 1 onwards.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University Medical Center Groningen, Groningen, Netherlands

Status

Recruiting

Address

University Medical Center Groningen

Groningen, , 9713

Leiden, Netherlands

Status

Recruiting

Address

Leiden University Medical Center, Dept. of Clinical Oncology

Leiden, , 2333

Radboud university medical center, Nijmegen, Netherlands

Status

Recruiting

Address

Radboud university medical center

Nijmegen, , 6525

Barcelona, Spain

Status

Recruiting

Address

Hospital Vall Hebrón, Unidad de Investigación en Terapia Molecular (UITM)

Barcelona, , 08035

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