Trials / Active Not Recruiting
Active Not RecruitingNCT05544929
A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers
A Phase I, Open-label, Multi-center Study of KFA115 as a Single Agent and in Combination With Pembrolizumab in Patients With Select Advanced Cancers
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 126 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
- Carcinoma, Non-Small-Cell Lung
- Cutaneous Melanoma
- Carcinoma, Renal Cell
- Carcinoma, Ovarian Epithelial
- Nasopharyngeal Carcinoma
- Carcinoma, Thymic
- Anal Cancer
- Mesothelioma
- Esophagogastric Cancer
- High Microsatellite Instability Colorectal Carcinoma
- Squamous Cell Carcinoma of Head and Neck
- Triple Negative Breast Neoplasms
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KFA115 | Immunomodulatory agent |
| DRUG | pembrolizumab | Anti-PD-1 antibody |
Timeline
- Start date
- 2022-10-26
- Primary completion
- 2027-09-01
- Completion
- 2027-09-01
- First posted
- 2022-09-19
- Last updated
- 2026-01-06
Locations
19 sites across 12 countries: United States, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05544929. Inclusion in this directory is not an endorsement.