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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
466
Novel small molecule
Karmanos Cancer Center
Detroit, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
NEXT Oncology
Irving, Texas, United States
START Mountain
Salt Lake City, Utah, United States
NEXT Oncology
Fairfax, Virginia, United States
Fred Hutchinson
Seattle, Washington, United States
Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors
Number of patients with dose limiting toxicities, treatment emergent adverse events (TEAE) and serious adverse events (SAE) and laboratory abnormalities
Time frame: First 28 days of dosing (DLT evaluation period)
Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s))
Number of patients with DLTs, TEAEs and SAEs and laboratory abnormalities
Time frame: First 28 days of dosing (DLT evaluation period)
Phase 2: Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s)
Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI
Time frame: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development
Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)
Time frame: Periodic efficacy assessments from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Confirm the optimal NUV-1511 target tumor types for further development
Overall response rate per RECIST 1.1 (Composite response rate for mCRPC patients only, if enrolled in Phase 2)
Time frame: Periodic efficacy assessments from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 1: Explore preliminary efficacy of NUV-1511
Overall response rate and duration of response per RECIST 1.1. Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI.
Time frame: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 1: Explore preliminary efficacy of NUV-1511
Overall response rate and duration of response per composite response rate (for mCRPC). Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI.
Time frame: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 1: Explore preliminary efficacy of NUV-1511
Overall response rate and duration of response per response rates in specific disease markers. Efficacy measures may include tumor assessments, as assessed by CT scans, PET/CT, whole body bone scan and MRI.
Time frame: From date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Characterize the PK profile of NUV-1511
Parameters include, but not limited to, maximum observed plasma concentration (Cmax)
Time frame: Periodic PK sample collection from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first.
Characterize the PK profile of NUV-1511
Parameters include, but not limited to, area under the plasma concentration-time curve (AUC)
Time frame: Periodic PK sample collection from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first.
Phase 2: Further evaluate the safety and efficacy of NUV-1511
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Incidence of TEAEs and SAEs
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Laboratory abnormalities
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Duration of response
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Clinical best response
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Progression free survival
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Overall survival
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
PK exposure-response modeling, which includes measuring plasma concentration versus overall response rate
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
PK exposure-response modeling, which includes measuring plasma concentration versus progression free survival
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
PK exposure-response modeling, which includes measuring plasma concentration versus treatment emergent adverse events and serious adverse events.
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Response rates in disease-specific markers
Time frame: Ongoing monitoring of safety and efficacy from date of enrollment to date of disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first