Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 studied for the treatment of advanced cancers, including non-small-cell lung carcinoma, cutaneous melanoma, renal cell carcinoma, ovarian epithelial carcinoma, nasopharyngeal carcinoma, thymic carcinoma, anal cancer, mesothelioma, esophagogastric cancer, high microsatellite instability colorectal carcinoma, squamous cell carcinoma of the head and neck, and triple negative breast neoplasms.
KFA115 is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is currently in Phase 1 clinical development.
KFA115 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study is currently active but not recruiting participants.
KFA115 is being evaluated in a Phase 1 clinical trial with the identifier NCT05544929. The study is assessing the safety and efficacy of KFA115 alone and in combination with pembrolizumab in patients with select advanced cancers. The trial is active but not recruiting and has a target enrollment of 126 participants.
Yes, KFA115 is being studied both alone and in combination with pembrolizumab in a Phase 1 clinical trial. The study is designed to evaluate the safety and efficacy of these treatment approaches in patients with various advanced solid tumors.
The KFA115 Phase 1 clinical trial is being conducted across multiple countries, including the United States, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Korea, Spain, and Taiwan. The study enrolls adults aged 18 years and older.