NUV-1511 / Nuvation Bio - LARVOL DELTA

NUV-1511-01: Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=466 | Active, not recruiting | Sponsor: Nuvation Bio Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • First-in-human • Breast Cancer • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2

NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors (Businesswire) - "The Company expects to provide an update from the Phase 1/2 dose escalation study of NUV-1511 by year end 2025."

P1/2 data • Solid Tumor

Second Quarter 2025 and Recent Corporate Highlights (Businesswire) - "Discussions with the FDA regarding registration-enabling trials of safusidenib are ongoing, and the Company plans to provide additional updates in the second half of 2025...The Company expects to provide an update from the Phase 1/2 dose escalation study of NUV-1511 in the second half of 2025....To date, our only source of product revenue has been from the U.S. sales of IBTROZI. We began shipping IBTROZI to our U.S. customers in June 2025. Product revenue, net from U.S. sales of IBTROZI was approximately $1.2 million for the three months ended June 30, 2025."

New trial • Sales • Trial status • Glioma • Non Small Cell Lung Cancer

Nuvation Bio Reports First Quarter 2025 Financial Results and Provides Business Update (Businesswire) - "Recent Pipeline Updates: (i) Taletrectinib, ROS1 inhibitor: Advanced ROS1+ NSCLC: The Priority Review of the Company’s NDA for taletrectinib for advanced ROS1+ NSCLC (line agnostic, full approval) is progressing on time with all planned inspections now completed. The PDUFA goal date of June 23, 2025, positions Nuvation Bio to commercialize taletrectinib in the U.S., if approved, in mid-2025...; (ii) Safusidenib, mIDH1 inhibitor: Diffuse IDH1-mutant glioma: The Company expects to provide an update on the pivotal study design for the safusidenib program in the second half of 2025; (iii) NUV-1511, drug-drug conjugate (DDC): Advanced solid tumors: The Company expects to provide an update from the Phase 1/2 dose escalation study of NUV-1511 in the second half of 2025."

Clinical protocol • Launch • P1/2 data • PDUFA • Glioma • Non Small Cell Lung Cancer

Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=466 | Recruiting | Sponsor: Nuvation Bio Inc.

Metastases • New P1/2 trial • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Nuvation Bio Doses First Patient in Phase 1/2 Study of NUV-1511 for the Treatment of Advanced Solid Tumors (Businesswire) - "Nuvation Bio...announced that the first patient has been dosed in a Phase 1/2 study of NUV-1511, the Company’s first DDC to enter the clinic....The dose escalation portion of the study employs a flexible design that allows for the potential to explore two dosing schedules for NUV-1511 with the goal of establishing the recommended Phase 2 dose. The study will initially evaluate safety and tolerability, pharmacokinetic profile, and assess for signs of clinical activity in patients with advanced solid tumors..."

Trial status • HER2 Negative Breast Cancer • Metastatic Castration-Resistant Prostate Cancer • Ovarian Cancer • Pancreatic Cancer

Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-1511 for the Treatment of Advanced Solid Tumors (Businesswire) - "Nuvation Bio...announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application to evaluate NUV-1511, the first clinical candidate from the company’s novel drug-drug conjugate (DDC) platform....The dose escalation portion of the Phase 1/2 study will initially evaluate safety and tolerability, and explore the potential for clinical efficacy, in patients with advanced solid tumors who previously received and progressed on or after treatment with Enhertu and/or Trodelvy per approved FDA labeling, human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer, metastatic castration-resistant prostate cancer (mCRPC), pancreatic cancer, and platinum-resistant ovarian cancer (PROC)....Company anticipates initiating a Phase 1/2 clinical study of NUV-1511 in 1H 2024."

IND • New P1/2 trial • HER2 Negative Breast Cancer • Metastatic Castration-Resistant Prostate Cancer • Ovarian Cancer

Nuvation Bio Reports Third Quarter 2023 Financial Results and Provides Business Update (Businesswire) - "Nuvation Bio remains on track to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023."

IND • Oncology

Nuvation Bio Reports First Quarter 2023 Financial Results and Provides Business Update (Businesswire) - "Nominated first clinical candidate. Nuvation Bio remains on track to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023."

IND • New molecule • Oncology

Nuvation Bio Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update (Businesswire) - "Drug-Drug Conjugate Platform: Solid tumors - Nominated first clinical candidate. Nuvation Bio expects to submit an Investigational New Drug (IND) application for an undisclosed DDC candidate with the U.S. Food and Drug Administration by year end 2023."

IND • Oncology • Solid Tumor