Status: | Marker: KRAS

Title
A phase I open-label dose escalation trial of BI 1701963 as monotherapy and in combination with trametinib in patients with KRAS mutated advanced or metastatic solid tumours
Study Number

Indication
Solid Tumor with previously-identified activating KRAS mutation in tumor tissue.
Primary Objective
Secondary objectives are to evaluate the safety and tolerability of BI 1701963 as monotherapy and in combination with trametinib, to characterize pharmacokinetics and pharmacodynamics, and to evaluate first efficacy signals.
In- and exclusion Criteria
  • Previously identified activating KRAS mutation in tumor tissue or blood prior to screening. Activating mutations may include but are not limited to: KRAS mutations in exon 2 (G12, G13), exon 3 (A59, Q61) and exon 4 (K117, A146)
  • Documented disease progression despite appropriate prior standard therapies or for whom no standard therapy exists for their tumor type and disease stage
  • Previous anticancer chemotherapy within 3 weeks of the first administration of trial drug. Previous anticancer hormonal treatment or anticancer immunotherapy within 2 weeks of the first administration of trial drugs.
  • Previous treatment with RAS, MAPK or SOS1 targeting agents
  • Radiotherapy within 4 weeks prior to start of treatment
Study Design
Phase I, multicenter
Responsibilities
Boehringer Ingelheim
Trial Centre
University Hospital of Cologne
Dep. I of Internal Medicine
Phone: +49 221 478 87008
Fax: +49 221 478 87010
lungenkrebs@uk-koeln.de
Principal investigator
PD Dr. Matthias Scheffler

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