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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Part 1 dose escalation only: Disease progression under or following standard therapy and/or disease for which no available standard therapy of proven benefit
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up parts 1 and 2: up to 12 months
Awards & highlights
Study Summary
This trial is studying a drug called Debio 0123 to see if it is safe and effective in treating adults with advanced solid tumors.
Who is the study for?
Adults with advanced solid tumors that have returned or worsened after treatment, or when no effective standard therapy exists. Participants must be in good physical condition (ECOG PS 0-1), have a life expectancy of at least 3 months, and adequate organ function. They should agree to use contraception and comply with study procedures. Exclusions include active secondary cancers needing treatment within the last 6 months, recent major surgery, brain tumors/metastases requiring recent treatment, current infections needing systemic drugs, pregnancy/breastfeeding, inability to take oral meds.Check my eligibility
What is being tested?
The trial is testing Debio 0123 as a solo therapy for solid tumors in two parts: Part 1 finds the safest highest dose; Part 2 uses this dose to assess safety further and see how well it works against specific tumor types. The drug's given repeatedly to adults whose cancer has come back or gotten worse despite previous treatments.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions seen with cancer therapies such as fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems. Organ-specific inflammation could occur due to immune system activation by the drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition worsened despite treatment, or there's no proven treatment for it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ parts 1 and 2: up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~parts 1 and 2: up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part 1: Maximum Tolerated Dose (MTD) as Determined by Percentage of Participants with Dose Limiting Toxicities (DLTs)
Part 1: Recommended Phase 2 Dose (RP2D) as Determined by Percentage of Participants with DLTs and Cumulative Safety Data
Part 2: Overall Response Rate (ORR)
+3 moreSecondary outcome measures
Part 1: Percentage of Participants with SAEs
Part 1: Percentage of Participants with TEAEs and Laboratory Abnormalities
Part 1: Plasma Concentration of Debio 0123
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part 2: ExpansionExperimental Treatment1 Intervention
Debio 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-driven selection (arm B), and solid tumor with biomarker-driven selection (arm C).
Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention
Participants 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.
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Who is running the clinical trial?
Debiopharm International SALead Sponsor
50 Previous Clinical Trials
7,026 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured using specific criteria.I don't have severe side effects from past treatments, except for mild anemia, hair loss, or controlled thyroid issues.My condition worsened despite treatment, or there's no proven treatment for it.I have not had a heart attack, stroke in the last 6 months, severe heart failure, uncontrolled chest pain, fainting without a known cause, dangerous heart rhythms needing treatment, a family history of sudden cardiac death, or heart damage from past chemotherapy.My cancer is advanced or has spread and confirmed by lab tests.I am fully active or can carry out light work.I haven't needed treatment for another cancer, except for certain skin or superficial cancers, in the last 6 months.I am currently taking medication for an infection.I cannot or will not take pills by mouth.I have a stomach or intestine problem that affects how I absorb medicine.I am 18 or older with cancer that has worsened or returned after standard treatment.My cancer is confirmed to be advanced or has spread, and it's not blood cancer.My blood, liver, kidney, and clotting tests are within normal ranges.I had major surgery less than 4 weeks ago or haven't recovered from it.My brain tumors are stable, without symptoms, and haven't needed treatment in the last month.My ovarian, peritoneal, or fallopian tube cancer has returned and worsened after platinum-based treatment.My uterine cancer has worsened after platinum-based treatment.I haven't had cancer treatment aimed at curing it within the last 28 days, except for pain relief radiation.I haven't had any live vaccines in the last 28 days and don't plan to get any.I am willing to have a biopsy or have an available tumor sample.
Research Study Groups:
This trial has the following groups:- Group 1: Part 1: Dose Escalation
- Group 2: Part 2: Expansion
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared Debio 0123 for public use?
"Given that this is a Phase 1 trial, meaning that there is only limited data to support safety and efficacy, our team at Power has given Debio 0123 a safety score of 1."
Answered by AI
Are we currently enrolling individuals for this clinical trial?
"Yes, this trial is still looking for patients. The clinicaltrials.gov website reports that the trial was posted on November 5th, 2021 and was last edited on October 21st, 2022."
Answered by AI
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