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Also known as NVP-KFA115
KFA115 · 1 trial · 12 indications
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
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
| Arm | Type | Description |
|---|---|---|
| Single-agent KFA115 | EXPERIMENTAL | KFA115 monotherapy |
| KFA115 run-in (1 cycle) + pembrolizumab | EXPERIMENTAL | 1-cycle KFA115 run-in followed by addition of pembrolizumab |
| KFA115 + pembrolizumab | EXPERIMENTAL | KFA115 + pembrolizumab combination given concurrently |
| Name | Type | Description |
|---|---|---|
| KFA115 | DRUG | Immunomodulatory agent |
| pembrolizumab | DRUG | Anti-PD-1 antibody |
Inclusion Criteria: * Non-small cell lung cancer with historic PD-L1 ≥ 1%, as determined locally using a clinically accepted assay. Patients must have experienced benefit from previous anti-PD(L)1-containing therapy for at least 4 months based on investigator-assessed disease stability or response ...
KFA115 is an investigational small molecule being developed by Novartis AG for the treatment of advanced solid tumors, including non-small cell lung cancer. It is a Phase 1 clinical-stage agent and has not been approved by the FDA. It is being studied both as a single agent and in combination with pembrolizumab.
KFA115 is being evaluated in a Phase 1 clinical trial for patients with advanced non-small cell lung cancer and other select solid tumors. It is an investigational therapy and is not approved for any indication. The study is enrolling adults aged 18 years and older with biomarker-selected cancers.
KFA115 is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. Novartis is the sponsor of the ongoing Phase 1 clinical trial evaluating KFA115 in multiple advanced cancer types.
KFA115 is in Phase 1 clinical development. The only registered trial is a Phase 1 study that is currently active but not recruiting. KFA115 has not received FDA approval and remains an investigational agent.
KFA115 is being studied in one clinical trial, NCT05544929, titled "A Study of Safety and Efficacy of KFA115 Alone and in Combo With Pembrolizumab in Patients With Select Advanced Cancers." The trial is active but not recruiting and has an estimated enrollment of 126 participants across multiple countries.
Yes, the Phase 1 trial NCT05544929 for KFA115 is biomarker-selected, meaning participants are chosen based on specific molecular characteristics of their tumors. The study enrolls patients with advanced solid tumors, including non-small cell lung cancer, cutaneous melanoma, renal cell carcinoma, and others.