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SNCTP000004577 | BASEC2021-00911

ANV419 EINZELSUBSTANZ ERSTE STUDIE AM MENSCHEN PHASE 1: EINE OFFENE, 5DOSIS-STEIGERUNGSSTUDIE BEI PATIENTEN MIT REZIDIVIERTEN/REFRAKTÄREN 6FORTGESCHRITTENEN SOLIDEN TUMOREN UND MULTIPLEM MYELOM.

Datenbasis: BASEC (Import vom 26.04.2024)
Geändert: 22.08.2023, 10:40
Krankheitskategorie: Melanom

Zusammenfassende Beschreibung der Studie (Datenquelle: 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).

Untersuchte Krankheiten(Datenquelle: BASEC)

fortgeschrittenen oder rezidivierenden soliden Tumoren oder multiplem Myelom

Seltene Krankheit (Datenquelle: BASEC)

Nein

Untersuchte Intervention (z.B. Medikament, Therapie, Kampagne) (Datenquelle: BASEC)

relapsed/refractory advanced solid tumors and multiple myeloma

Kriterien zur Teilnahme an der Studie (Datenquelle: 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.

Ausschlusskriterien (Datenquelle: 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.

Studiendurchführungsorte

Durchführungsorte in der Schweiz (Datenquelle: BASEC)

St Gallen

Kontakt für weitere Auskünfte zur Studie

Angaben zur Kontaktperson in der Schweiz (Datenquelle: BASEC)

Markus Jörger
+41714942922
markus.joerger@kssg.ch

Bewilligung durch Ethikkommission (Datenquelle: BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Datum der Bewilligung durch die Ethikkommission

13.08.2021

Weitere Studienidentifikationsnummern

Studienidentifikationsnummer der Ethikkommission (BASEC-ID) (Datenquelle: BASEC)

2021-00911
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