Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NUV-1511 · 1 trial · 5 indications
Number of patients with dose limiting toxicities, treatment emergent adverse events (TEAE) and serious adverse events (SAE) and laboratory abnormalities
Number of patients with DLTs, TEAEs and SAEs and laboratory abnormalities
Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI
Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)
Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)
| Arm | Type | Description |
|---|---|---|
| Phase 1: Schedule A | OTHER | Schedule A evaluating escalating dose levels of NUV-1511 |
| Phase 1: Schedule B | OTHER | Schedule B evaluating escalating dose levels of NUV-1511 |
| Phase 2: Tumor Type 1 | EXPERIMENTAL | Tumor type to be selected after Phase 1. Dose Schedules A and B to be further evaluated. |
| Phase 2: Tumor Type 2 | EXPERIMENTAL | Tumor type to be selected after Phase 1. Dose level and schedule to be selected after identification of the recommended phase 2 dose (RP2D) in Phase 1. |
| Phase 2: All comers | EXPERIMENTAL | All tumor types allowed per protocol. Dose level and schedule to be selected after identification of the recommended phase 2 dose (RP2D) in Phase 1. |
| Name | Type | Description |
|---|---|---|
| NUV-1511 | DRUG | Novel small molecule |
Inclusion Criteria: * Phase 1 Dose Escalation cohorts, Phase 1 Backfill cohorts, and Phase 2 Tumor Type-Specific cohort(s): must meet one of the following criteria: * HER2- metastatic breast cancer: 1. Hormone refractory hormone receptor positive metastatic breast cancer with progression on or a...
| 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 |
NUV-1511 is an investigational small molecule being developed by Nuvation Bio Inc. for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and is designed for biomarker-selected patients. NUV-1511 has not been approved by the FDA and remains under clinical investigation.
NUV-1511 is being studied for advanced solid tumors, including HER2-negative breast cancer, metastatic castration-resistant prostate cancer (mCRPC), pancreatic cancer, and platinum-resistant ovarian cancer (PROC). It is an investigational therapy in Phase 1 development and is not approved for any indication.
NUV-1511 is developed by Nuvation Bio Inc., a biopharmaceutical company whose common stock trades on the New York Stock Exchange under the ticker symbol NUVB. Nuvation Bio is the sponsor of the clinical program evaluating NUV-1511 in advanced solid tumors.
NUV-1511 is in Phase 1 clinical development. It is an investigational small molecule that has not received FDA approval. The Phase 1 program is evaluating the drug in adult patients with advanced solid tumors, and the trial is currently active but not recruiting.
NUV-1511 is being evaluated in one clinical trial, NCT06334432, titled "Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors." The Phase 1 trial has an enrollment of 466 patients, is active but not recruiting, and is conducted in the United States.
The NCT06334432 trial enrolls adults 18 years and older of all sexes with advanced solid tumors, including HER2-negative breast cancer, metastatic castration-resistant prostate cancer, pancreatic cancer, and platinum-resistant ovarian cancer. It is a controlled, biomarker-selected Phase 1 study and does not accept healthy volunteers.