A Phase 1/2, First-in-Human, Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

NUV-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors. The Phase 1 portion include patients with advanced solid tumors and is designed to determine the safety and the tolerability of doses of NUV-1511. In Phase 2, NUV-1511 will be given to determine the efficacy of patients with advanced solid tumors.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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:

‣ Hormone refractory hormone receptor positive metastatic breast cancer with progression on or after treatment with CDK4/6 inhibitor plus at least one line of systemic chemotherapy in the advanced setting

⁃ Triple negative metastatic breast cancer with progression after at one line of systemic chemotherapy in the advanced setting.

• Patients with advanced solid tumors that progressed on or following treatment with Enhertu and/or Trodelvy per label

• mCRPC: Histologically confirmed, metastatic castration resistant adenocarcinoma of the prostate

‣ May have received up to 2 prior chemotherapies in mCRPC setting

⁃ Prior therapy with PARP (poly-ADP ribose polymerase) inhibitor, PLUVICTO, Radium-223, or Provenge is allowed

• Pancreatic cancer: PDAC (pancreatic ductal adenocarcinoma) with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting.

• PROC: Histologically or cytologically confirmed platinum-resistant high-grade serous ovarian, fallopian, or primary peritoneal cancer;

• Phase 1 Dose Escalation cohorts, Phase 1 Backfill cohorts, and Phase 2 Tumor Type-Specific cohorts (except mCRPC; see inclusion criterion 2 above): must have measurable disease per RECIST 1.1

• Phase 2 All Comers cohort: Patients with advanced solid tumors that have progressed during or after treatment with approved therapies or for whom there is no standard effective therapy available.

• Adequate bone marrow and organ function.

• Provide informed consent, which includes compliance with protocol-specified requirements and restrictions

Locations
United States
Michigan
Karmanos Cancer Center
RECRUITING
Detroit
North Carolina
Carolina BioOncology Institute
RECRUITING
Huntersville
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New York
Memorial Sloan-Kettering Cancer Center
RECRUITING
New York
Texas
NEXT Oncology
RECRUITING
Irving
Utah
START Mountain
RECRUITING
Salt Lake City
Virginia
NEXT Oncology
RECRUITING
Fairfax
Washington
Fred Hutchinson
RECRUITING
Seattle
Contact Information
Primary
Nuvation Bio
clinicaltrials@nuvationbio.com
332-208-6102
Time Frame
Start Date: 2024-03-14
Estimated Completion Date: 2027-10
Participants
Target number of participants: 466
Treatments
Other: Phase 1: Schedule A
Schedule A evaluating escalating dose levels of NUV-1511
Other: Phase 1: Schedule B
Schedule B evaluating escalating dose levels of NUV-1511
Experimental: Phase 2: Tumor Type 1
Tumor type to be selected after Phase 1. Dose Schedules A and B to be further evaluated.
Experimental: Phase 2: Tumor Type 2
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.
Experimental: Phase 2: All comers
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.
Sponsors
Leads: Nuvation Bio Inc.

This content was sourced from clinicaltrials.gov