What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly anti-tumor agents like Debio 0123, include fatigue, nausea, vomiting, diarrhea, and hematologic toxicities such as neutropenia and anemia. Other potential side effects can include skin reactions, mucositis, and increased risk of infections. Immunotherapies may also cause immune-related adverse events such as pneumonitis, colitis, hepatitis, and endocrinopathies. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several anti-tumor agents for the treatment of advanced solid tumors, focusing on immunotherapy and targeted therapies. Notable approvals include pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1, and have shown efficacy in various solid tumors such as melanoma and non-small cell lung cancer. Additionally, targeted therapies like vemurafenib, a BRAF inhibitor, have been approved for BRAF-mutant melanoma. These treatments aim to enhance the body's immune response against cancer cells or target specific genetic mutations within the tumors.

What other types of research exist?

Promising novel alternatives to Debio 0123 for solid tumor patients include: <ol> <li>Pembrolizumab (Keytruda) - an anti-PD-1 antibody showing efficacy in various solid tumors.</li> <li></li> </ol> Nivolumab (Opdivo) - another anti-PD-1 antibody with broad applications in solid tumors. 3. Atezolizumab (Tecentriq) - an anti-PD-L1 antibody used in multiple solid tumor types. 4. Cabozantinib - a tyrosine kinase inhibitor effective in renal cell carcinoma and other solid tumors. 5. Relatlimab - a novel LAG-3 inhibitor showing promise in combination with nivolumab for melanoma and other solid tumors.

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Debio 0123 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Debiopharm International SA

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

Must not have

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, or any cardiotoxicity experienced after previous chemotherapy

Known infection requiring systemic use of an antibiotic or antiviral agent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Debio 0123, a new drug, in adults with advanced solid tumors that haven't responded to other treatments. It aims to find the safest dose and see if the drug can shrink 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.

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.

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 below

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My condition worsened despite treatment, or there's no proven treatment for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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.

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I am currently taking medication for an infection.

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I cannot or will not take pills by mouth.

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I have a stomach or intestine problem that affects how I absorb medicine.

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I had major surgery less than 4 weeks ago or haven't recovered from it.

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I haven't had any live vaccines in the last 28 days and don't plan to get any.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Part 1: Plasma Concentration of Debio 0123

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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 (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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as those inhibiting specific proteins or pathways essential for tumor growth (e.g., HER2 inhibitors for certain breast cancers), offer a more precise approach with potentially fewer side effects. Immunotherapy, including checkpoint inhibitors, enhances the body's immune response against cancer cells. These treatments are crucial for solid tumor patients as they provide multiple avenues to attack the cancer, potentially improving outcomes and offering options when standard therapies fail.