Brève description de l’étude (Source de données: BASEC)
This is a Phase 1 open-label study in patients with relapsed/refractory advanced solid tumors and multiple myelomaconsisting of two phases. Phase 1 will identify the single agent MTD and/orRP2D in single patient cohorts (Part A) and 3+3 cohorts (Part B).
Maladies étudiées(Source de données: BASEC)
fortgeschrittenen oder rezidivierenden soliden Tumoren oder multiplem Myelom
Maladie rare
(Source de données: BASEC)
Non
Intervention étudiée (p. ex., médicament, thérapie, campagne)
(Source de données: BASEC)
relapsed/refractory advanced solid tumors and multiple myeloma
Critères de participation à l’étude
(Source de données: BASEC)
1.Ability of the patient,or legal guardian,to understand the purpose of the study, provide signed and dated informed consentprior to performing any protocol-related procedures (including Screening evaluations),and be able and willing to comply with the study procedures.
2.Male or female aged ≥ 18 years.
3.Advanced solid tumors with evidence of progressive disease as per RECISTv1.1no longer than 3 months before Informed Consent form (ICF)signature, without any subsequent curative intent treatment.
Critères d’exclusion
(Source de données: BASEC)
1.Symptomatic central nervous system (CNS) metastases. Definitely treated CNS metastases (e.g.,radiotherapy) stable for at least 6 weeks prior to Day 1 of study drug administration are acceptable.
2.Participants with an active second malignancy. Patients with precancerous lesions, concomitant early stages of prostate or breast cancer not requiring active treatment (past conditions currently resolved > 3 years prior to Screening are also acceptable), and squamous cell carcinoma of the skin not requiring systemic treatment are acceptable.
3.Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including uncontrolled diabetesmellitus, history of relevant pulmonary disorders(e.g.,severe bronchospasm, obstructive pulmonary disease), hyperthyroidismdue to thyroiditis and known autoimmune diseases or other disease with ongoing fibrosis. Stable vitiligo, autoimmune thyroiditis,and preexisting treated type 1 diabetes are acceptable and are not exclusion criteria.
Lieux de réalisation des études
Lieux de réalisation des études en Suisse
(Source de données: BASEC)
St-Gall
Contact pour plus d’informations sur l’étude
Données sur la personne de contact en Suisse
(Source de données: BASEC)
Markus Jörger
+41714942922
markus.joerger@kssg.ch
Autorisation de la commission d’éthique (Source de données: BASEC)
Nom de la commission d’éthique chargée de l’autorisation (dans le cas d’études multicentriques, uniquement la commission directrice)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
Date d’autorisation de la commission d’éthique
13.08.2021
Plus de numéros d’identification d’étude
Numéro d’identification de l’étude de la commission d’éthique (BASEC-ID)
(Source de données: BASEC)
2021-00911
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