Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CI-8993 · 1 trial · 1 indication
The highest dose at a schedule, at which the DLT rate during the first cycle of this study (28 days from the first full dose) is \< 33% in at least 6 patients.
The RP2D will be a dose considered to be appropriately safe for a target phase 2 population and exhibit PK and PD characteristics that are favorable and considered likely to support clinical efficacy of CI-8993. The RP2D will be defined by the Safety Review Committee (SRC) based on PK, PD, safety, efficacy results in this study, as well as practical limitations.
| Arm | Type | Description |
|---|---|---|
| CI-8993 dose escalation | EXPERIMENTAL | Patients will be administered CI-8993 intravenously at a planned infusion rate over 2 hours at planned step-doses and subsequent full doses. The planned schedule of administration is every 2 weeks. The MTD of full doses of CI-8993 will be determined based on the occurrence of DLTs 28 days from the first full dose. Eligible patients may receive CI-8993 at the dose and schedule, according to their assigned cohorts, until disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| CI-8993 | DRUG | CI-8993 is a fully human immunoglobulin (Ig) G1κ monoclonal antibody (mAb) against the VISTA ligand |
Inclusion Criteria: 1. Patient must be ≥18 years of age 2. Patients must have the following disease related criteria: * any type of solid tumor malignancy (non-lymphoma) that is metastatic or unresectable and considered relapsed and/or refractory to prior therapy * must have evaluable diseas...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
CI-8993 is an investigational small molecule developed by Curis, Inc. for the treatment of advanced solid tumor malignancies. It is designed to act on the VISTA protein and has been studied in a Phase 1 clinical trial. It is not an approved therapy and remains in clinical development.
CI-8993 targets VISTA, a protein that functions as an immune checkpoint regulator. By binding to VISTA, the drug is intended to modulate immune suppression within the tumor microenvironment. VISTA is a protein target, and CI-8993 is being evaluated in oncology for advanced solid tumors.
CI-8993 is being developed by Curis, Inc., a biopharmaceutical company that trades under the ticker symbol CRIS. Curis is the sponsor of the clinical program evaluating CI-8993 in patients with advanced solid tumor malignancies.
CI-8993 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 study of CI-8993 in advanced solid tumor malignancies has been completed.
CI-8993 has been evaluated in one clinical trial, NCT04475523, titled a Phase 1 Study of CI-8993 Anti-VISTA Antibody in Patients With Advanced Solid Tumor Malignancies. The trial enrolled 26 patients across the United States and Australia and is listed as completed.