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NUV-1511 for Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by Nuvation Bio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights
No Placebo-Only Group
Summary
"This trial is testing a new drug called NUV-1511 in patients with advanced solid tumors. The first part of the trial will focus on assessing the safety and tolerability of different doses of N
Who is the study for?
This trial is for adults with advanced solid tumors, including ovarian, prostate, pancreatic, and breast cancer. Participants should have a tumor that's progressed after treatment or has no available therapy. They must be in good physical condition with acceptable organ function.
What is being tested?
The study tests NUV-1511's safety and effectiveness on advanced solid tumors. It starts with Phase 1 to find the right dose based on tolerance levels. In Phase 2, the focus shifts to how well NUV-1511 works against these cancers.
What are the potential side effects?
As this is a first-in-human study of NUV-1511, specific side effects are not yet known but may include typical reactions seen in cancer treatments such as nausea, fatigue, allergic reactions or more serious complications.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors
Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s))
Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development
+2 moreSecondary study objectives
Characterize the PK profile of NUV-1511
Phase 1: Explore preliminary efficacy of NUV-1511
Phase 2: Further evaluate the safety and efficacy of NUV-1511
Other study objectives
Evaluate drug exposure-response relationship
Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity
Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Group I: Phase 2: Tumor Type 2Experimental Treatment1 Intervention
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.
Group II: Phase 2: Tumor Type 1Experimental Treatment1 Intervention
Tumor type to be selected after Phase 1. Dose Schedules A and B to be further evaluated.
Group III: Phase 2: All comersExperimental Treatment1 Intervention
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.
Group IV: Phase 1: Schedule BExperimental Treatment1 Intervention
Schedule B evaluating escalating dose levels of NUV-1511
Group V: Phase 1: Schedule AExperimental Treatment1 Intervention
Schedule A evaluating escalating dose levels of NUV-1511
Find a Location
Who is running the clinical trial?
Nuvation Bio Inc.Lead Sponsor
9 Previous Clinical Trials
1,146 Total Patients Enrolled
3 Trials studying Breast Cancer
731 Patients Enrolled for Breast Cancer