Advanced Solid TumorsPhase 1NCT03968653
Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors
A Phase 1 study testing Debio 0123 and Carboplatin in people with Advanced Solid Tumors, run by Debiopharm International SA at 8 sites in 2 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Debio 0123 and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 30 Jul 2019to 23 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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 locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Spain5 sites
Hospital Vall Hebrón, Unidad de Investigación en Terapia Molecular (UITM)
Barcelona, 08035
Clinica Universidad de Navarra
Madrid, 28027
Hospital Universitario Virgen de la Victoria
Málaga, 29010
Clinica Universidad de Navarra - Pamplona
Pamplona, 31008
Instituto Valenciano de Oncologia
Valencia, 46009
Netherlands3 sites
University Medical Center Groningen
Groningen, 9713
Leiden University Medical Center, Dept. of Clinical Oncology
Leiden, 2333
Radboud university medical center
Nijmegen, 6525
About this study
Official title: A Phase 1 Study of Oral Debio 0123 in Combination With Carboplatin in Patients With Advanced Solid Tumors
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- Debio 0123, Carboplatin
- Keywords
- WEE1-inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debio 0123Drug
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.
CarboplatinDrug
Carboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 2 onwards in Group A.
Debio 0123Drug
Debio 0123 will be given as an oral capsule for 3 or 6 days during each 21-day cycle.
CarboplatinDrug
Carboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 1 onwards.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation: Group A: Debio 0123 | Experimental | 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. Receives: Drug: Debio 0123; Drug: Carboplatin |
| Dose Escalation: Group B: Debio 0123 | Experimental | Participants will receive Debio 0123, orally, daily, for 6 days during each cycle in combination with carboplatin IV infusion. Receives: Drug: Debio 0123; Drug: Carboplatin |
| Dose Expansion: Debio 0123 | Experimental | 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. Receives: Drug: Debio 0123; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Recommended Phase 2 Dose (RP2D) of Debio 0123 When Administered in Combination with Carboplatin
Measured: 2 Cycles i.e., 45 days (Cycle 1 = 24 days; Cycle 2 onwards = 21 day-cycles)
Dose Expansion: Percentage of Participants with Treatment-Emergent Serious Adverse Events (SAEs)
Measured: Up to 46 months
Dose Expansion: Percentage of Participants with Treatment Discontinuations and Treatment Modifications Due to Adverse Events (AEs) and Laboratory Abnormalities
Measured: Up to 46 months
Dose Expansion: Overall Response Rate (ORR)
Measured: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (up to 46 months)
Secondary outcomes (22)
Dose Escalation: Percentage of Participants with Dose Limiting Toxicities (DLTs) of Debio 0123 When Administered in Combination with Carboplatin
Measured: 2 Cycles i.e., 45 days (Cycle 1 = 24 days; Cycle 2 onwards = 21 day-cycles)
Dose Escalation: Percentage of Participants with Treatment-Emergent SAEs
Measured: Up to 46 months
Dose Escalation: Percentage of Participants with TEAEs and Laboratory Abnormalities
Measured: Up to 46 months
Dose Escalation: Percentage of Participants with Treatment Discontinuations and Treatment Modifications Due to Adverse Events (AEs) and Laboratory Abnormalities
Measured: Up to 46 months
Dose Escalation: Number of Participants with Changes in Vital Signs
Measured: Day 1 of each cycle (up to 46 months) [Group A: Cycle 1 = 24 days, Cycle 2 onwards and all cycles in Group B = 21-day cycles]
Dose Escalation: Number of Participants with Changes in ECG
Measured: Up to 46 months
Number of Participants with Change in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Measured: Day 1 of each cycle (up to 46 months) [Group A: Cycle 1 = 24 days, Cycle 2 onwards and all cycles in Group B = 21-day cycles]
Dose Escalation: Group A: Plasma Concentration of Debio 0123
The pharmacokinetics (PK) of Debio 0123 will be evaluated in plasma.
Measured: Day -3 to predose Day 1; postdose at multiple time points from Day 3 to Day 21 in Cycle 1 (Cycle 1 = 24 days), Day 1 on Cycle 2 (Cycle 2 onwards = 21 day-cycles) and subsequent cycles (Up to 46 months)
Dose Escalation: Group A: Concentration of Debio 0123 in Urine
The PK of Debio 0123 will be evaluated in urine.
Measured: Day -3 to Day 21 Cycle 1 (Cycle 1 = 24 days)
Dose Escalation: Group A: Area Under the Concentration Curve Over the Time 0 to Infinity (AUC∞) of Free Platinum in Plasma Ultrafiltrate of Carboplatin in Combination
Measured: Day 1 to Day 21 Cycle 2 (Cycle 2 onwards = 21 day-cycles) and subsequent cycles (Up to 46 months)
Dose Escalation: Group B: Plasma Concentration of Debio 0123
The PK of Debio 0123 will be evaluated in plasma.
Measured: Cycle 1 to Cycle 3: Days 1 and 10 (cycle length = 21 days)
Dose Escalation: Group B: Concentration of Free Platinum in Plasma of Carboplatin
Measured: Cycle 1 Day 1 (cycle length = 21 days)
Dose Escalation: Correlation Between Plasma Concentration of Debio 0123 and Changes in QT Interval Corrected Using Fridericia's Formula (QTcF)
Measured: Up to 46 months
Dose Escalation: Tumor Response
Measured: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (Up to 46 months)
Dose Escalation: Progression Free-Survival (PFS)
Measured: From the start of study treatment until disease progression or death from any cause, whichever occurs first (Up to 46 months)
Dose Escalation: Overall Survival (OS)
Measured: From the start of study treatment until death from any cause (Up to 46 months)
Dose Expansion: Best Overall Response (BOR)
Measured: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (Up to 46 months)
Dose Expansion: Disease Control Rate
Measured: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (Up to 46 months)
Dose Expansion: Number of Participants with Best Change in Tumor Size
Measured: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (Up to 46 months)
Dose Expansion: Duration of Response (DOR)
Measured: Up to disease progression (Up to 46 months)
Dose Expansion: Time to Progression (TTP)
Measured: Time from treatment initiation until objective tumor progression (Up to 46 months)
Dose Expansion: Plasma Concentration of Debio 0123
Measured: Cycle 1 and Cycle 2: Days 1, 3, 8 and 15 (cycle length = 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start30 Jul 2019
- Primary completion23 Oct 2025
- Study completion23 Oct 2025
Why it stopped: This trial was concluded for strategic reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968653
- Sponsor's protocol ID
- Debio 0123-101
- Other IDs
- 2024-510984-52, U1111-1302-8405
- Status last verified
- Nov 2025
- First submitted
- 28 May 2019
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Oral Debio 0123 in Combination With Carboplatin in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT03968653
- Acronym / sponsor ID
- Debio 0123-101
- Conditions
- Advanced Solid Tumors
- Keywords
- WEE1-inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This trial was concluded for strategic reasons.
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 23 Oct 2025 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation: Group A: Debio 0123 | Experimental | Drug: Debio 0123, Drug: CarboplatinParticipants 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. |
| Dose Escalation: Group B: Debio 0123 | Experimental | Drug: Debio 0123, Drug: CarboplatinParticipants will receive Debio 0123, orally, daily, for 6 days during each cycle in combination with carboplatin IV infusion. |
| Dose Expansion: Debio 0123 | Experimental | Drug: Debio 0123, Drug: CarboplatinParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debio 0123Debio 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 | Dose Escalation: Group A: Debio 0123 |
| CarboplatinCarboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 2 onwards in Group A. | Drug | Dose Escalation: Group A: Debio 0123 |
| Debio 0123Debio 0123 will be given as an oral capsule for 3 or 6 days during each 21-day cycle. | Drug | Dose Escalation: Group B: Debio 0123, Dose Expansion: Debio 0123 |
| CarboplatinCarboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 1 onwards. | Drug | Dose Escalation: Group B: Debio 0123, Dose Expansion: Debio 0123 |
Primary outcome
Dose Escalation: Recommended Phase 2 Dose (RP2D) of Debio 0123 When Administered in Combination with Carboplatin
Time frame: 2 Cycles i.e., 45 days (Cycle 1 = 24 days; Cycle 2 onwards = 21 day-cycles)
Dose Expansion: Percentage of Participants with Treatment-Emergent Serious Adverse Events (SAEs)
Time frame: Up to 46 months
Dose Expansion: Percentage of Participants with Treatment Discontinuations and Treatment Modifications Due to Adverse Events (AEs) and Laboratory Abnormalities
Time frame: Up to 46 months
Dose Expansion: Overall Response Rate (ORR)
Time frame: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (up to 46 months)
22 secondary outcomes
Dose Escalation: Percentage of Participants with Dose Limiting Toxicities (DLTs) of Debio 0123 When Administered in Combination with Carboplatin
Time frame: 2 Cycles i.e., 45 days (Cycle 1 = 24 days; Cycle 2 onwards = 21 day-cycles)
Dose Escalation: Percentage of Participants with Treatment-Emergent SAEs
Time frame: Up to 46 months
Dose Escalation: Percentage of Participants with TEAEs and Laboratory Abnormalities
Time frame: Up to 46 months
Dose Escalation: Percentage of Participants with Treatment Discontinuations and Treatment Modifications Due to Adverse Events (AEs) and Laboratory Abnormalities
Time frame: Up to 46 months
Dose Escalation: Number of Participants with Changes in Vital Signs
Time frame: Day 1 of each cycle (up to 46 months) [Group A: Cycle 1 = 24 days, Cycle 2 onwards and all cycles in Group B = 21-day cycles]
Dose Escalation: Number of Participants with Changes in ECG
Time frame: Up to 46 months
Number of Participants with Change in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Time frame: Day 1 of each cycle (up to 46 months) [Group A: Cycle 1 = 24 days, Cycle 2 onwards and all cycles in Group B = 21-day cycles]
Dose Escalation: Group A: Plasma Concentration of Debio 0123
Time frame: Day -3 to predose Day 1; postdose at multiple time points from Day 3 to Day 21 in Cycle 1 (Cycle 1 = 24 days), Day 1 on Cycle 2 (Cycle 2 onwards = 21 day-cycles) and subsequent cycles (Up to 46 months)
Dose Escalation: Group A: Concentration of Debio 0123 in Urine
Time frame: Day -3 to Day 21 Cycle 1 (Cycle 1 = 24 days)
Dose Escalation: Group A: Area Under the Concentration Curve Over the Time 0 to Infinity (AUC∞) of Free Platinum in Plasma Ultrafiltrate of Carboplatin in Combination
Time frame: Day 1 to Day 21 Cycle 2 (Cycle 2 onwards = 21 day-cycles) and subsequent cycles (Up to 46 months)
Dose Escalation: Group B: Plasma Concentration of Debio 0123
Time frame: Cycle 1 to Cycle 3: Days 1 and 10 (cycle length = 21 days)
Dose Escalation: Group B: Concentration of Free Platinum in Plasma of Carboplatin
Time frame: Cycle 1 Day 1 (cycle length = 21 days)
Dose Escalation: Correlation Between Plasma Concentration of Debio 0123 and Changes in QT Interval Corrected Using Fridericia's Formula (QTcF)
Time frame: Up to 46 months
Dose Escalation: Tumor Response
Time frame: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (Up to 46 months)
Dose Escalation: Progression Free-Survival (PFS)
Time frame: From the start of study treatment until disease progression or death from any cause, whichever occurs first (Up to 46 months)
Dose Escalation: Overall Survival (OS)
Time frame: From the start of study treatment until death from any cause (Up to 46 months)
Dose Expansion: Best Overall Response (BOR)
Time frame: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (Up to 46 months)
Dose Expansion: Disease Control Rate
Time frame: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (Up to 46 months)
Dose Expansion: Number of Participants with Best Change in Tumor Size
Time frame: From the start of study treatment until disease progression/recurrence is documented or analysis cut-off, whichever occurs first (Up to 46 months)
Dose Expansion: Duration of Response (DOR)
Time frame: Up to disease progression (Up to 46 months)
Dose Expansion: Time to Progression (TTP)
Time frame: Time from treatment initiation until objective tumor progression (Up to 46 months)
Dose Expansion: Plasma Concentration of Debio 0123
Time frame: Cycle 1 and Cycle 2: Days 1, 3, 8 and 15 (cycle length = 21 days)
Results and safety
The study was stopped early (reason given: This trial was concluded for strategic reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Debio 0123 and Carboplatin in people with Advanced Solid Tumors, run by Debiopharm International SA at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This trial was concluded for strategic reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation: Recommended Phase 2 Dose (RP2D) of Debio 0123 When Administered in Combination with Carboplatin (time frame: 2 Cycles i.e., 45 days (Cycle 1 = 24 days; Cycle 2 onwards = 21 day-cycles)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.