Neoplasms

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Cola

1-cycle KFA115 run-in followed by addition of pembrolizumab

KFA115 + pembrolizumab combination given concurrently

KFA115

pembrolizumab

Novartis Pharmaceuticals

Justin Gainor

Amy Ciriaco

Kristen Spencer

Aric Fellers

Jason Luke

Katie Robbins

Melissa Johnson

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.

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.

A Study of Safety and Efficacy of KFA115 Alone and in Combination 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

A DLT is defined as an adverse event or abnormal laboratory value that occurs during the DLT evaluation period where the relationship to study treatment cannot be ruled out, and is not primarily related to disease, disease progression, intercurrent illness, or concomitant medications and meets the criteria defined in the study protocol

Incidence and severity of adverse events and serious adverse events, including changes in laboratory values, vital signs, and electrocardiograms qualifying and reported as AEs

Number of dose interruptions of KFA115 and pembrolizumab, and number of dose reductions of KFA115

Dose intensity of KFA115 and pembrolizumab is defined as the ratio of actual cumulative dose received and actual duration of exposure

BOR is defined as the best response recorded from the start of the treatment until disease progression/recurrence

PFS is defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause

DOR is defined as the time from the date of the first documented response (CR or PR) to the date of the first documented progression as per RECIST v1.1 or death due to underlying cancer

TTP is defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to underlying cancer

The maximum (peak) observed plasma or serum drug concentration after single dose administration

The minimum observed plasma or serum drug concentration reached during the time interval between two dose administrations

The time to reach maximum (peak) plasma or serum drug concentration after single dose administration

The elimination half-life associated with the terminal slope of a semi logarithmic concentration-time curve

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers	NCT05544929	Carcinoma, Non-... Cutaneous Melan... Carcinoma, Rena... Carcinoma, Ovar... Nasopharyngeal ... Carcinoma, Thym... Anal Cancer Mesothelioma Esophagogastric... High Microsatel... Squamous Cell C... Triple Negative...	KFA115 pembrolizumab	18 Years -	Novartis
A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers	NCT05544929	Carcinoma, Non-... Cutaneous Melan... Carcinoma, Rena... Carcinoma, Ovar... Nasopharyngeal ... Carcinoma, Thym... Anal Cancer Mesothelioma Esophagogastric... High Microsatel... Squamous Cell C... Triple Negative...	KFA115 pembrolizumab	18 Years -	Novartis

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