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Clinical Trial Summary

The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with pembrolizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or recommended dose.


Clinical Trial Description

This is a phase I, open-label, multi-center study of KFA115 as a single agent and in combination with pembrolizumab. The study consists of a dose escalation part, followed by dose expansion part(s) for single-agent KFA115 and KFA115 in combination with pembrolizumab. The escalation parts will characterize safety and tolerability. After the determination of the maximum tolerated dose (MTD) / recommended dose (RD), the dose expansion parts will assess the preliminary anti-tumor activity in defined patient populations and further assess the safety and tolerability at MTD/RD. ;


Study Design


Related Conditions & MeSH terms

  • Anal Cancer
  • Anus Neoplasms
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Ovarian Epithelial
  • Carcinoma, Renal Cell
  • Carcinoma, Squamous Cell
  • Carcinoma, Thymic
  • Colorectal Neoplasms
  • Cutaneous Melanoma
  • Esophagogastric Cancer
  • Melanoma
  • Mesothelioma
  • Mesothelioma, Malignant
  • Microsatellite Instability
  • Nasopharyngeal Carcinoma
  • Neoplasms
  • Squamous Cell Carcinoma of Head and Neck
  • Thymoma
  • Triple Negative Breast Neoplasms

NCT number NCT05544929
Study type Interventional
Source Novartis
Contact Novartis Pharmaceuticals
Phone 1-888-669-6682
Email novartis.email@novartis.com
Status Recruiting
Phase Phase 1
Start date October 26, 2022
Completion date February 20, 2026

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