Phase 2 Lymphoma Trial, Recruiting NCT05765812 Sponsor: Debiopharm International SA Condition: Lymphoma
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Phase 2 Lymphoma Trial, Recruiting

NCT05765812
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have given written consent before any study-related procedures begin
  • People aged 18 or older
  • People willing to provide a stored or fresh tumour sample if one is available (providing a sample is not required to start treatment)
  • People whose bone marrow, liver, and kidney are functioning well enough as determined by the trial team
  • People who are able and willing to attend scheduled visits, follow treatment plans, and complete required tests and procedures
  • People willing to use highly effective methods of contraception during the trial
  • People whose doctor estimates they have a life expectancy of at least 3 months
  • People whose brain disease can be detected or measured by a contrast-enhanced MRI brain scan (using a dye called gadolinium)
  • People taking steroid medications who have been on a stable or reducing dose of no more than 4 mg of dexamethasone per day (or no more than 25 mg of prednisone per day) for at least 7 days before starting the study treatment
  • People with seizures whose seizures are well controlled on a stable anti-seizure medication regimen
  • People who have had no more than 1 or 2 prior treatment courses depending on which part of the trial they are joining, where the first treatment must have included a chemotherapy drug called temozolomide (TMZ) given together with radiotherapy
  • People whose brain tumour has been confirmed to have returned or grown, either through a biopsy or a contrast-enhanced MRI brain scan
  • People with a performance score (a measure of general health and ability to carry out daily activities) of 60 or above on the Karnofsky scale (70 or above for some parts of the trial)
  • People with a confirmed brain tumour diagnosis matching one of the specific tumour types required for the part of the trial they are entering (confirm with trial site for exact tumour type requirements)

Who may not be able to join:

  • People who cannot have a gadolinium contrast-enhanced MRI scan for medical reasons
  • People who have received any anti-cancer treatment, biological therapy, experimental treatment, or radiotherapy aimed at curing their cancer within 28 days before starting the study treatment
  • People who have a known allergy or serious reaction to the study drugs (Debio 0123, temozolomide, or dacarbazine) or to any ingredients in their formulations
  • People who have previously been treated with any WEE1 inhibitor drug
  • People who have had another cancer requiring active treatment in the last 2 years, with some exceptions such as certain low-risk or non-invasive cancers that have been successfully treated (confirm with trial site for the full list of exceptions)
  • People whose heart is not pumping blood effectively enough (specifically, a left ventricular ejection fraction below 55%)
  • People joining certain parts of the trial (Arms B and C of Phase 1) who have previously received radiation, chemotherapy, biological therapy, or other local treatments for their brain tumour
  • People joining certain parts of the trial (Arms B and C of Phase 1) whose prior treatment would cause radiation fields to overlap with those planned in this study
  • People joining the dose expansion or Phase 2 parts of the trial who have had more than one prior course of systemic (whole-body) treatment for their brain tumour

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Study Director, Debiopharm International SA

Phone: +41 21 321 01 11

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Debiopharm International SA
Registry
ClinicalTrials.gov
Start date
15 May 2023
Est. completion
1 September 2028

Where this trial is recruiting

🇪🇸 Spain 🇨🇭 Switzerland 🇺🇸 United States

Primary endpoints

Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-limiting Toxicities (DLTs); Phase 1 (Dose Escalation): Number of Participants With At Least One Treatment-emergent Adverse Event (TEAE); Phase 1 (Dose Escalation): Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, Electrocardiogram (ECG), and Echocardiogram (ECHO) Parameters; Phase 1 (Dose Escalation): Change From Baseline in Karnofsky Performance Status (KPS) Score; Phase 1 (Dose Expansion): Number of Participants With At Least One Treatment-emergent Adverse Event (TEAE); Phase 1 (Do...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov