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Advanced Solid TumorsPhase 1NCT05109975

A Study to Evaluate Safety and Preliminary Anti-tumor Activity of Debio 0123 as Monotherapy in Adult Participants With Advanced Solid Tumors

A Phase 1 study testing Debio 0123 in people with Advanced Solid Tumors, run by Debiopharm International SA at 15 sites in 3 countries.

Terminated

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

Official record
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Trial summary

This study has two parts: Part 1 and Part 2. The purpose of this study in Part 1, Dose Escalation Part is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of Debio 0123 as monotherapy with repeated dosing in adults 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
15 sitesin 3 countries
Study dates
5 Nov 2021to 24 Apr 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

  • Part 1 dose escalation only:
  • Histologically or cytologically confirmed locally advanced or metastatic solid tumors.
  • Measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
  • Disease progression under or following standard therapy and/or disease for which no available standard therapy of proven benefit.
  • Part 2 expansion only:
  • Measurable disease per RECIST version 1.1 criteria for each arm.
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  • Participants (≥18 years old) who progressed or have recurrence of one of the tumor types specified in the study arms following standard therapy according to RECIST version 1.1, or for whom, in the opinion of the Investigator, no effective standard therapy exists.
  • Arm A: Histologically or cytologically confirmed USC that recurred or progressed following at least 1 prior platinum-based line of therapy for management of advanced or metastatic disease.
  • Arm B: Histologically or cytologically confirmed, recurrent, high-grade EOC, primary peritoneal cancer, or fallopian tube cancer with cyclin E1 driven selection. Participants must have progressed after at least 1 prior platinum-based therapy for advanced/metastatic disease.
  • Arm C: Histologically or cytologically confirmed, locally advanced or metastatic solid tumor with biomarker-driven selection.
  • Part 1 dose escalation and Part 2 expansion:
  • Accessible tumor for biopsy, and participant willing to undergo tumor biopsy unless archived tumor sample is available.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  • Life expectancy of at least 3 months, in the best judgment of the Investigator.
  • Adequate bone marrow, liver biochemistry, renal function, and coagulation status.
  • Willing to practice highly effective methods of contraception.
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Who cannot join

  • Participants with active second malignancies requiring therapy in the last 6 months, with the exception of superficial bladder cancers, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated surgically.
  • Current use of an investigational agent or a medical device.
  • Major surgery ≤4 weeks prior to the first dose of study treatment or who have not recovered from the surgical procedure.
  • Brain tumors and/or brain metastases unless they are asymptomatic, stable on recent imaging (not dated more than 28 days from the inclusion date), and have not required active treatment in the last month before study entry.
  • History of myocardial infarction or stroke within 6 months, congestive heart failure greater than New York Heart Association (NYHA) class II, unstable angina pectoris, unexplained recurrent syncope, cardiac arrhythmia requiring treatment, family history of sudden death from cardiac-related causes before the age of 50, or any cardiotoxicity experienced after previous chemotherapy.
  • Known infection requiring systemic use of an antibiotic or antiviral agent.
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  • Immunization with live or live-attenuated vaccine within 28 days prior to study inclusion or planned injection of live or live-attenuated vaccines.
  • Pregnancy or breast-feeding.
  • Inability or unwillingness to swallow oral medication.
  • Clinically significant gastrointestinal abnormality that would affect the absorption of the drug.
  • Any anti-cancer treatment, monoclonal antibodies/biologics, investigational treatment, or radiotherapy with curative intent within 28 days prior to starting study treatment. Palliative radiation for pain relief is allowed up to 1 week prior to starting study treatment.
  • Unresolved AEs or toxicities due to previous treatments, i.e., >Grade 1. Exceptions will be made for Grade 2 anemia (if hemoglobin is not less than 9 g/dL or 5.6 mmol/L) and >Grade 2 alopecia and endocrinopathies controlled by replacement therapy (example, hypothyroidism due to immune checkpoint inhibitors).
  • [Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.]

Trial locations and contacts

15 sites in 3 countries.

15 sites in 3 countries

Spain8 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Institut Catala de Oncologia

    Girona, 17007

  • Clinica Universidad de Navarra

    Madrid, 28027

  • START Madrid. Hospital Fundación Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario La Paz

    Madrid, 28046

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

United States4 sites

  • South Texas Accelerated Research Therapeutics (START) Midwest

    Grand Rapids, Michigan, 49546

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

    New York, New York, 10021

  • South Texas Accelerated Research Therapeutics (START)

    San Antonio, Texas, 78229

Other trials in United States

Switzerland3 sites

  • Istituto Oncologico della Svizzera italiana - Ente Ospedaliero Cantonale

    Bellinzona, 6500

  • Kantonsspital St. Gallen, Rorschacher Strasse 95

    Sankt Gallen, 9007

  • Universitätsspital Zürich, Dermatologische Klinik

    Zurich, 8058

Other trials in Switzerland

About this study

Official title: A Phase 1, Dose-finding Study of Debio 0123 as Monotherapy in Adult Patients With Advanced Solid Tumors, Followed by an Expansion Part to Assess Safety and Preliminary Anti-tumor Activity

This study has two parts: Part 1 and Part 2. The purpose of this study in Part 1, Dose Escalation Part is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of Debio 0123 as monotherapy with repeated dosing in adults with advanced solid tumors that recurred or progressed after prior therapy and/or for whom no standard therapy of proven benefit is available.

The purpose in Part 2, Expansion Part of this study, is to characterize the safety and tolerability of Debio 0123 in each study arm and overall when administered as monotherapy at the MTD/RP2D determined during the Dose Escalation Part 1 and to evaluate the preliminary anti-tumor activity of Debio 0123 when administered as monotherapy to participants in each study arm.

Being tested
Debio 0123
Keywords
Advanced Solid Tumors, 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 orally during 21-day treatment cycles.

Study groups in NCT05109975
Study groupRoleWhat they receive
Part 1: Dose EscalationExperimentalParticipants will receive Debio 0123 orally in escalating dose cohorts during each 21-day treatment cycle until progression of disease, unacceptable toxicity, participant's withdrawal, or Investigator's decision, whichever occurs first.
Receives: Drug: Debio 0123
Part 2: ExpansionExperimentalDebio 0123 at the RP2D established in Part 1 participants with uterine serous carcinoma (USC) (arm A), recurrent or progressive, high-grade epithelial ovarian cancer (EOC) with cyclin E1 (arm B), and solid tumor with biomarker-driven selection (arm C).
Receives: Drug: Debio 0123

What is being measured

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

  1. Part 1: Maximum Tolerated Dose (MTD) as Determined by Percentage of Participants with Dose Limiting Toxicities (DLTs)

    Measured: Cycle 1 (each cycle is 21 days)

  2. Part 1: Recommended Phase 2 Dose (RP2D) as Determined by Percentage of Participants with DLTs and Cumulative Safety Data

    Measured: Cycle 1 (each cycle is 21 days)

  3. Part 2: Percentage of Participants with Serious Adverse Events (SAEs)

    Measured: Up to 30 days after the last dose of study treatment (up to 13 months)

  4. Part 2: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Laboratory Abnormalities

    Measured: Up to 30 days after the last dose of study treatment (up to 13 months)

  5. Part 2: Percentage of Participants with Treatment Discontinuations and Treatment Modifications due to Adverse Events (AEs) and Laboratory Abnormalities

    Measured: Up to end of study treatment (up to 12 months)

  6. Part 2: Overall Response Rate (ORR)

    Measured: From the start of study treatment until disease progression (up to 12 months)

Secondary outcomes (4)

  1. Part 1: Percentage of Participants with SAEs

    Measured: Up to 30 days after the last dose of study treatment (up to 13 months)

  2. Part 1: Percentage of Participants with TEAEs and Laboratory Abnormalities

    Measured: Up to 30 days after the last dose of study treatment (up to 13 months)

  3. Part 1: Plasma Concentration of Debio 0123

    The pharmacokinetics (PK) of Debio-0123 will be evaluated in plasma.

    Measured: Pre-dose and at multiple time points up to 8 hours (h) on Day 1, Cycle 1 in Part 1 and 4 h on Day 1, Cycle 1 in Part 2 (each cycle is 21 days)

  4. Parts 1 and 2: Anti-Tumor Activity as Assessed by Percentage of Participants with Tumor Response

    Measured: Parts 1 and 2: Up to 12 months

Timeline

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

  1. First posted5 Nov 2021
  2. Study start5 Nov 2021
  3. Primary completion24 Apr 2026
  4. Study completion24 Apr 2026

Why it stopped: This 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
Parallel groups
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05109975
Sponsor's protocol ID
Debio 0123-102
Other IDs
2023-504824-24, 2023
Status last verified
Jun 2026
First submitted
26 Oct 2021
Last updated
23 Jun 2026
Results posted
No
Data monitoring committee
Yes
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 in people with Advanced Solid Tumors, run by Debiopharm International SA at 15 sites in 3 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 17 inclusion and 13 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain, United States, Switzerland. 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?

Part 1: Maximum Tolerated Dose (MTD) as Determined by Percentage of Participants with Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 (each cycle is 21 days)). The study lists 6 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 NCT05109975.

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 23 Jun 2026.

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