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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
CI-8993 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in clinical development for patients with advanced solid tumor malignancies. The drug is being studied as a potential therapy for this oncology indication, though it remains investigational and has not been approved by regulatory authorities.
CI-8993 is an anti-VISTA antibody, meaning it targets VISTA (V-domain Ig suppressor of T cell activation), an immune checkpoint protein. By targeting VISTA, the drug aims to modulate the immune system's response to tumors. This mechanism is being investigated in the context of solid tumor malignancies.
CI-8993 is being developed by Curis, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol CRIS. The company is conducting clinical research on this investigational drug for the treatment of solid tumors.
CI-8993 is in Phase 1 clinical development. It is an investigational drug that has not been approved by the FDA or any other regulatory agency. The drug is still in early-stage clinical trials to evaluate its safety, tolerability, and potential efficacy in patients with advanced solid tumors.
CI-8993 has one completed Phase 1 clinical trial registered as NCT04475523. This study, titled "Phase 1 Study of CI-8993 Anti-VISTA Antibody in Patients With Advanced Solid Tumor Malignancies," enrolled 26 participants across the United States and Australia. The trial was uncontrolled and not randomized, and it included patients aged 18 years and older.
Yes, CI-8993 is an anti-VISTA antibody. The drug is designed to target VISTA, an immune checkpoint protein. This mechanism is being studied in the context of solid tumor treatment, and the Phase 1 clinical trial specifically evaluated CI-8993 as an anti-VISTA antibody in patients with advanced solid tumor malignancies.