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Small Cell Lung Cancer RecurrentPhase 1NCT05815160

Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy

A Phase 1 study testing Debio 0123, Etoposide and Carboplatin in people with Small Cell Lung Cancer Recurrent, run by Debiopharm International SA at 10 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary purpose of part 1 (dose escalation) of this study is to identify the recommended dose and to characterize the safety and tolerability of Debio 0123 in combination with carboplatin and etoposide. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Small Cell Lung Cancer Recurrent
What is being tested?
Debio 0123, Etoposide and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
10 sitesin 2 countries
Study dates
2 May 2023to 9 Mar 2026
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

  • Histologically or cytologically confirmed SCLC
  • Tumor that is not bleeding
  • Prior platinum-based chemotherapy (carboplatin and/or cisplatin)
  • Part 1 (dose escalation): Recurrence or progression after a minimum of 45 days since the last dose of prior standard platinum-based therapy
  • Part 2 (expansion): Recurrence or progression after a minimum of 90 days since the last dose of prior standard platinum-based therapy
  • Measurable disease per RECIST 1.1
Show all 11Show fewer
  • Willingness and ability to undergo tumor biopsy unless an archived tumor sample is available
  • ECOG performance status of 0-1
  • Life expectancy of at least 3 months in the best judgment of the Investigator
  • Adequate bone marrow, hepatic and renal function, adequate coagulation status
  • Willingness and ability to comply with scheduled visits, study treatment plans, laboratory tests, and other study procedures.

Who cannot join

  • Use of an investigational agent or medical device within 28 days prior to first dose of study treatment.
  • History of other malignancies requiring active treatment in the last 2 years prior to first dose of study treatment, except for superficial bladder cancers, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated with curative intent.
  • History of myocardial infarction or stroke in the last 6 months prior to first dose of study treatment, congestive heart failure greater than New York Heart Association (NYHA) class II, unstable angina pectoris, unexplained recurrent syncope, cardiac arrhythmia requiring treatment, known family history of sudden death from cardiac-related causes before the age of 50, or any cardiotoxicity experienced after previous chemotherapy.
  • Left ventricular ejection fraction (LVEF) below 55%.
  • QTcF >450 ms, history of congenital long QT syndrome, or clinically significant conduction abnormality, or any conduction abnormality that may increase the risk of TdP.
  • Clinically significant gastrointestinal abnormality that could affect the absorption of orally administered drugs
Show all 19Show fewer
  • Major surgery ≤4 weeks prior to first dose of study treatment or incomplete recovery from the surgical procedure at the time of the first dose of study treatment.
  • Radiographic findings showing tumor involvement with large blood vessels or poor demarcation from them with increased risk for bleeding.
  • Radiographic findings of Interstitial lung disease (ILD) that are considered clinically significant.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
  • Any infection requiring the systemic use of an antibiotic or antiviral agent.
  • Known Hepatitis C virus (HCV), Hepatitis B virus (HBV), or Human Immunodeficiency Virus (HIV) infection. Participants with past infections that have been cured may be enrolled.
  • Immunization with live or live-attenuated vaccine within 28 days prior to first dose of study treatment.
  • Inability or unwillingness to swallow oral medications.
  • Anticancer treatment (including chemotherapy), monoclonal antibodies/biologics, or radiotherapy with curative intent within 28 days prior to first dose of study treatment. Palliative radiation is allowed up to 1 week prior to study treatment start.
  • Unresolved AEs or toxicities due to previous treatments >Grade 1. Note: Participants with ≤Grade 2 alopecia or endocrinopathies controlled by replacement therapy are exceptions and may qualify for the study.
  • Hypersensitivity to Debio 0123, etoposide or carboplatin, or any of the excipients found in the formulations for Debio 0123, etoposide, or carboplatin. If a prior hypersensitivity to carboplatin has been observed but a successful desensitization was performed for the participant, he or she may be eligible for the study.
  • Prior exposure to any WEE1 inhibitor
  • Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Spain9 sites

  • Hospital Universitario de A Coruna

    A Coruña, 15006

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Institut Catala D'Oncologia - Badalona

    Barcelona, 08908

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro. START Madrid - Centro Integral Oncológico Clara Campal (CIOCC)

    Madrid, 28050

  • NEXT Oncology Madrid

    Madrid, 28223

  • Hospital Quironsalud Malaga

    Málaga, 29004

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

United States1 site

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Phase 1 Dose-Escalation and Expansion Study to Assess Safety and Preliminary Antitumor Activity of Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy

The primary purpose of part 1 (dose escalation) of this study is to identify the recommended dose and to characterize the safety and tolerability of Debio 0123 in combination with carboplatin and etoposide.

The primary purpose of part 2 (dose expansion) of this study is to characterize the safety and tolerability of Debio 0123 at the recommended dose when administered in combination with carboplatin and etoposide.

Being tested
Debio 0123, Etoposide, Carboplatin
Keywords
Small cell lung cancer (SCLC), Recurrent, Debio 0123, Carboplatin, Etoposide, WEE1 inhibitor, WEE-1 inhibitor, Platinum-based therapy, Platinum-based chemotherapy
Medical subject headings
Small Cell Lung Carcinoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Debio 0123Drug

    Administered as capsules.

  • EtoposideDrug

    Administered as IV infusion.

  • CarboplatinDrug

    Administered as IV infusion.

Study groups in NCT05815160
Study groupRoleWhat they receive
Part 1: Dose Escalation: Debio 0123 + Etoposide + CarboplatinExperimentalParticipants will receive Debio 0123 escalating doses, orally along with etoposide IV infusion and carboplatin IV infusion in 21-day cycles until disease progression or death or end of study.
Receives: Drug: Debio 0123; Drug: Etoposide; Drug: Carboplatin
Part 2: Dose Expansion: Debio 0123 + Etoposide + CarboplatinExperimentalParticipants will receive Debio 0123 recommended dose determined in Part 1 of the study, orally along with etoposide IV infusion and carboplatin IV infusion in 21-day cycles until disease progression or death or end of study.
Receives: Drug: Debio 0123; Drug: Etoposide; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

    Measured: Cycle 1 (Cycle=21 days)

  2. Parts 1 and 2: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE)

    Measured: Approximately up to 44 months

  3. Parts 1 and 2: Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, Electrocardiogram (ECG), and Echocardiogram Parameters

    Measured: Approximately up to 44 months

  4. Parts 1 and 2: Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)

    Measured: Baseline up to approximately 44 months

Secondary outcomes (19)

  1. Parts 1 and 2: Trough Concentration (Ctrough) of Debio 0123 and its Metabolite

    Measured: For Part 1: Predose from Day 2 to Day 11 of Cycle 1; For Part 2: Predose from Day 3 to Day 10 of Cycle 1 and only Day 8 of subsequent cycles up to Cycle 5 (Cycle=21 days)

  2. Parts 1 and 2: Maximum Plasma Concentration (Cmax) of Debio 0123 and its Metabolite

    Measured: For Part 1: Multiple timepoints post dose from Day 1 to Day 11 of Cycle 1 (Cycle=21 days); For Part 2: Will be derived from the population Pharmacokinetic (PK) model using the sparse samples collected

  3. Parts 1 and 2: Area Under the Concentration Curve Over 24 hours (AUC24h) of Debio 0123 and its Metabolite

    Measured: For Part 1: Multiple timepoints post dose from Day 1 to Day 11 of Cycle 1 (Cycle=21 days); For Part 2: Will be derived from the population PK model using the sparse samples collected

  4. Part 1: Time to Maximum Plasma Concentration (tmax) of Debio 0123 and its Metabolite

    Measured: Multiple timepoints post dose from Day 1 to Day 11 of Cycle 1 (Cycle=21 days)

  5. Part 1: Area Under the Concentration Curve up to the Last Measurable Concentration (AUClast) of Debio 0123 and its Metabolite

    Measured: Multiple timepoints post dose from Day 1 to Day 21 of Cycle 1 and Day 1 of Cycle 2 (Cycle=21 days)

  6. Part 1: Area Under the Concentration Curve up to Infinity (AUCinf) of Debio 0123 and its Metabolite

    Measured: Multiple timepoints post dose from Day 1 to Day 21 of Cycle 1 and Day 1 of Cycle 2 (Cycle=21 days)

  7. Part 1: Apparent Terminal Half-life (t1/2) of Debio 0123 and its Metabolite

    Measured: Multiple timepoints post dose from Day 1 to Day 21 of Cycle 1 and Day 1 of Cycle 2 (Cycle=21 days)

  8. Part 1: Apparent Clearance (CL/F) of Debio 0123

    Measured: Multiple timepoints post dose from Day 1 to Day 21 of Cycle 1 and Day 1 of Cycle 2 (Cycle=21 days)

  9. Part 1: Apparent Volume of Distribution (Vd/F) of Debio 0123

    Measured: Multiple timepoints post dose from Day 1 to Day 21 of Cycle 1 and Day 1 of Cycle 2 (Cycle=21 days)

  10. Part 1: Maximum Plasma Concentration (Cmax) of Etoposide

    Measured: Multiple timepoints from administration to post dose from Day 1 to Day 3 of Cycle 1 (Cycle=21 days)]

  11. Part 1: Area Under the Concentration Curve Over 24 hours (AUC24h) of Etoposide

    Measured: Multiple timepoints post dose from Day 1 to Day 5 of Cycle 1 (Cycle=21 days)

  12. Part 1: Trough Concentration (Ctrough) of Etoposide

    Measured: Predose from Day 2 to Day 5 of Cycle 1 (Cycle=21 days)

  13. Part 1: Maximum Plasma Concentration (Cmax) of Carboplatin

    Measured: Multiple timepoints from administration up to 6 hours post dose on Day 1 of Cycle 1 (Cycle=21 days)

  14. Parts 1 and 2: Percentage of Participants With Best Overall Response (BOR) Assessed as per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 Criteria

    Measured: From the start of study treatment until disease progression or end of study (up to approximately 44 months)

  15. Parts 1 and 2: Percentage of Participants With Objective Response (OR) Assessed as per RECIST 1.1 Criteria

    Measured: Up to end of study (approximately 44 months)

  16. Parts 1 and 2: Percentage of Participants With Disease Control (DC) Assessed as per RECIST 1.1 Criteria

    Measured: From the start of study treatment until disease progression or end of study (up to approximately 44 months)

  17. Parts 1 and 2: Duration of Response (DOR) Assessed as per RECIST 1.1 Criteria

    Measured: Up to disease progression or end of study (approximately 44 months)

  18. Parts 1 and 2: Progression Free Survival (PFS) Assessed as per RECIST 1.1 Criteria

    Measured: From the start of study treatment until disease progression or death or end of study (up to approximately 44 months)

  19. Part 2: Overall Survival

    Measured: From the start of study treatment until death from any cause or end of study (up to approximately 44 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start2 May 2023
  3. Primary completion9 Mar 2026
  4. Study completion9 Mar 2026

Why it stopped: The trial was concluded for strategic reasons.

Resources

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
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05815160
Sponsor's protocol ID
Debio 0123-SCLC-104
Other IDs
2024-510980-40-00, U1111-1302-8787
Status last verified
Apr 2026
First submitted
9 Mar 2023
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Debio 0123, Etoposide and Carboplatin in people with Small Cell Lung Cancer Recurrent, run by Debiopharm International SA at 10 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 11 inclusion and 19 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 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Spain, United States. 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: The 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?

Part 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs) (time frame: Cycle 1 (Cycle=21 days)). 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?

On the ClinicalTrials.gov record for NCT05815160.

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 4 May 2026.

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