JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05109975

Studienbeginn:
November 2021

Letztes Update:
29.03.2024

Wirkstoff:
Debio 0123

Indikation (Clinical Trials):
Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
Debiopharm International SA

Collaborator:
-

Kontakt

Debiopharm International S.A
Kontakt:
Phone: +41 21 321 01 11
E-Mail: clinicaltrials@debiopharm.com» Kontaktdaten anzeigen

Studienlocations
(3 von 11)

South Texas Accelerated Research Therapeutics (START) Midwest
49546 Grand Rapids
United StatesRekrutierend» Google-Maps

South Texas Accelerated Research Therapeutics (START)
78229 San Antonio
United StatesRekrutierend» Google-Maps

Hospital Universitari Vall d'Hebron
08035 Barcelona
SpainNoch nicht rekrutierend» Google-Maps

Institut Catala de Oncologia
17007 Girona
SpainNoch nicht rekrutierend» Google-Maps

Clinica Universidad de Navarra
28027 Madrid
SpainNoch nicht rekrutierend» Google-Maps

START Madrid. Hospital Fundación Jimenez Diaz
28040 Madrid
SpainNoch nicht rekrutierend» Google-Maps

Hospital Universitario 12 de Octubre
28041 Madrid
SpainNoch nicht rekrutierend» Google-Maps

Hospital Universitario La Paz
28046 Madrid
SpainNoch nicht rekrutierend» Google-Maps

Clinica Universidad de Navarra
31008 Pamplona
SpainNoch nicht rekrutierend» Google-Maps

Istituto Oncologico della Svizzera italiana - Ente Ospedaliero Cantonale
6500 Bellinzona
SwitzerlandNoch nicht rekrutierend» Google-Maps

Universitätsspital Zürich, Dermatologische Klinik
8058 Zürich
SwitzerlandAbgeschlossen» Google-Maps

Alle anzeigen

Studien-Informationen

Brief 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 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.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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.

- 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. 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,

specific solid tumors.

- 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.

Exclusion Criteria:

- 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, or any cardiotoxicity experienced after

previous chemotherapy.

- Known infection requiring systemic use of an antibiotic or antiviral agent.

- 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.

- Chemotherapy, monoclonal antibodies/biologics, 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.]

Studien-Rationale

Primary outcome:

1. 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))

2. Part 1: Recommended Phase 2 Dose (RP2D) as Determined by Percentage of Participants with DLTs and Cumulative Safety Data (Time Frame - Cycle 1 (each cycle is 21 days))

3. Part 2: Percentage of Participants with Serious Adverse Events (SAEs) (Time Frame - 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 (Time Frame - 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 (Time Frame - Up to end of study treatment (up to 12 months))

6. Part 2: Overall Response Rate (ORR) (Time Frame - From the start of study treatment until disease progression (up to 12 months))

Secondary outcome:

1. Part 1: Percentage of Participants with SAEs (Time Frame - 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 (Time Frame - Up to 30 days after the last dose of study treatment (up to 13 months))

3. Part 1: Plasma Concentration of Debio 0123 (Time Frame - 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)):
The pharmacokinetics (PK) of Debio-0123 will be evaluated in plasma.

4. Parts 1 and 2: Anti-Tumor Activity as Assessed by Percentage of Participants with Tumor Response (Time Frame - Parts 1 and 2: Up to 12 months)

Studien-Arme

Experimental: Part 1: Dose Escalation
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.
Experimental: Part 2: Expansion
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).

Geprüfte Regime

Debio 0123:
Debio 0123 orally during 21-day treatment cycles.

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

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

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!