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NUV-868 + Olaparib/Enzalutamide for 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
Patients with advanced solid tumors that have progressed during or after treatment with approved therapies or for which there is no standard effective therapy available (Phase 1)
One of the following tumor types: Ovarian, Pancreatic, Prostate, Breast, Other advanced tumors (Phase 1b), Ovarian, Pancreatic, Prostate, Breast (Phase 2)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)
Awards & highlights

Study Summary

This trial is testing a new drug, NUV-868, for safety and efficacy in patients with advanced solid tumors. The drug will be taken orally, either as a monotherapy or in combination with other drugs olaparib or enzalutamide, in 28-day cycles. The trial will continue until the disease progresses, there are unacceptable side effects, the patient withdraws consent, or the trial is terminated.

Who is the study for?
Adults with advanced solid tumors like ovarian, pancreatic, prostate, or breast cancer who have recovered from previous cancer therapy side effects and have good bone marrow and organ function. They must not be pregnant or breastfeeding, haven't had certain treatments recently, and can't have active brain disease.Check my eligibility
What is being tested?
NUV-868 is being tested alone and combined with Olaparib or Enzalutamide in patients with advanced solid tumors to find safe doses (Phase 1/1b) and test effectiveness (Phase 2). Patients take NUV-868 orally daily for 28-day cycles until they no longer benefit.See study design
What are the potential side effects?
Potential side effects of NUV-868, Olaparib, or Enzalutamide may include reactions related to the immune system's response to the drugs, gastrointestinal issues due to oral administration, fatigue from treatment regimens, as well as possible impacts on liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer has worsened despite treatment, or there's no effective treatment for it.
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My cancer is one of the specified types: ovarian, pancreatic, prostate, or breast.
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My cancer can be measured or seen on tests.
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I do not have any active brain or spinal cord diseases.
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I have recovered from side effects of previous cancer treatments.
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I do not have any active brain or spinal cord diseases.
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My BRCA/HRR status does not affect my eligibility for this study.
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My bone marrow and organs are functioning well.
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My cancer can be measured or is known to be present.
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I can perform all self-care but may not be able to work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks during the first 24 weeks and then every 12 weeks, up to an average of 12 months (end of treatment) 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 Monotherapy Dose Escalation: Safety and tolerability of NUV-868 to determine the recommended Phase 2 dose (RP2D)
Phase 1b Dose Escalation, NUV-868 + Enzalutamide: Pharmacokinetic (PK) profiles of NUV-868 and enzalutamide when administered in combination
Phase 1b Dose Escalation, NUV-868 + Enzalutamide: Safety and tolerability of NUV-868 in combination with enzalutamide to determine the RP2cD
+7 more

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2: NUV-868 MonotherapyExperimental Treatment1 Intervention
NUV-868 will be administered at the RP2D in one arm of a randomized Phase 2 combination (NUV-868 + enzalutamide) cohort.
Group II: Phase 2 Combination: NUV-868 + OlaparibExperimental Treatment2 Interventions
NUV-868 will be administered at the RP2cD. Olaparib will be administered at the RP2cD.
Group III: Phase 2 Combination: NUV-868 + EnzalutamideExperimental Treatment2 Interventions
NUV-868 will be administered at the RP2cD. Enzalutamide will be administered at the RP2cD.
Group IV: Phase 1b Combination: NUV-868 + OlaparibExperimental Treatment2 Interventions
NUV-868 will be administered at escalating dose levels in combination with olaparib until the recommended Phase 2 combination dose (RP2cD) is determined. 300 mg olaparib will be administered orally twice daily throughout the 28-day cycles of NUV-868.
Group V: Phase 1b Combination: NUV-868 + EnzalutamideExperimental Treatment2 Interventions
NUV-868 will be administered daily at escalating dose levels in combination with enzalutamide until the RP2cD is determined. 160 mg enzalutamide will be administered orally daily throughout the 28-day cycles of NUV-868.
Group VI: Phase 1 MonotherapyExperimental Treatment1 Intervention
NUV-868 will be administered at escalating dose levels until the maximum tolerated dose (MTD) is reached or a recommended Phase 2 dose (RP2D) is determined.
Group VII: Phase 2: Enzalutamide MonotherapyActive Control1 Intervention
160 mg enzalutamide will be administered orally daily in one arm of a randomized Phase 2 combination (NUV-868 + enzalutamide) cohort.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olaparib
2007
Completed Phase 4
~2140
Enzalutamide
2014
Completed Phase 4
~2760

Find a Location

Who is running the clinical trial?

Nuvation Bio Inc.Lead Sponsor
4 Previous Clinical Trials
540 Total Patients Enrolled

Media Library

NUV-868 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05252390 — Phase 1 & 2
Ovarian Cancer Research Study Groups: Phase 2: Enzalutamide Monotherapy, Phase 1 Monotherapy, Phase 1b Combination: NUV-868 + Olaparib, Phase 1b Combination: NUV-868 + Enzalutamide, Phase 2 Combination: NUV-868 + Olaparib, Phase 2 Combination: NUV-868 + Enzalutamide, Phase 2: NUV-868 Monotherapy
Ovarian Cancer Clinical Trial 2023: NUV-868 Highlights & Side Effects. Trial Name: NCT05252390 — Phase 1 & 2
NUV-868 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05252390 — Phase 1 & 2

Frequently Asked Questions

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

Are people still able to sign up for this experiment?

"That is accurate. The information available on clinicaltrials.gov demonstrates that this study, which was initially posted on 3/29/2022, is still recruiting participants. 246 individuals are needed for the trial taking place at 7 different locations."

Answered by AI

Are there any other locations where this experiment is taking place?

"Currently, there are 7 sites enrolling patients for this trial. The locations of these centres include Baltimore, Detroit, Huntersville and other cities. To reduce the amount of travel required, make sure to select the centre nearest you when enrolling."

Answered by AI

How many people are eligible to participate in this research project?

"In order to run the study, 246 people who meet the clinical trial's requirements must be recruited. The sponsor, Nuvation Bio Inc., will manage and operate the trial from different locations which include Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, Maryland as well as Karmanos Cancer Institute in Detroit, Michigan."

Answered by AI

Who else is applying?

What site did they apply to?
Center for Oncology and Blood Disorders
What portion of applicants met pre-screening criteria?
Met criteria
~328 spots leftby Jun 2026