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Phase 1: Schedule B for Ovarian Cancer

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

Study 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.Check my eligibility
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.See study design
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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 outcome measures
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 more

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
4 Previous Clinical Trials
731 Total Patients Enrolled
1 Trials studying Ovarian Cancer
657 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment for this study still ongoing at present?

"According to the details on clinicaltrials.gov, this clinical investigation is currently in search of eligible participants. The trial was initially disclosed on March 1st, 2024 and last revised on March 20th, 2024."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors
2024. "Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06334432.
All > Prostate Cancer Dallas > Fort Worth
~311 spots leftby Mar 2027
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