NUV-1511 for Solid Tumors

Recruiting at 7 trial locations

Overseen By Nuvation Bio

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Nuvation Bio Inc.

Must not be taking: Chemotherapy, Hormonal therapy

Disqualifiers: Active infection, Cardiac disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

466 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment, NUV-1511, for individuals with advanced solid tumors. The trial consists of two parts: the first identifies a safe dose, while the second evaluates its effectiveness against specific tumor types. Individuals with advanced cancers such as breast, prostate, pancreatic, or ovarian cancer that have not responded to other treatments may qualify. Participants must have cancers that have progressed despite treatment and must meet certain organ health criteria.

As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop chemotherapy, hormonal therapy (except certain hormone treatments), radiation therapy, or biological anticancer therapy at least 14 days before starting the study treatment. If you're on an investigational agent, you must stop it 14 to 21 days before, depending on the type of agent.

Is there any evidence suggesting that NUV-1511 is likely to be safe for humans?

Research has shown that NUV-1511 is being tested for safety and effectiveness in people with advanced solid tumors. The FDA has approved this drug for human testing, indicating it has passed some important checks. Similar studies at this stage typically assess safety and tolerance, meaning researchers examine whether the drug causes adverse side effects and how well the body handles it.

As this is the first human trial for NUV-1511, limited information exists from previous users. In early trials, researchers often begin with low doses to monitor reactions closely, gradually increasing the dose to determine the safest and most effective level. This process helps identify side effects early.

The safety of NUV-1511 remains under study, but the trial's careful approach aims to minimize risks for participants. Prospective participants should consult the study's doctors to understand all potential risks and benefits. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about NUV-1511 because it offers a potential new approach to treating solid tumors with its unique mechanism of action. Unlike traditional chemotherapy, which often targets rapidly dividing cells indiscriminately, NUV-1511 is designed to escalate doses strategically to identify the most effective yet tolerable dose for patients. This precision could lead to better-targeted treatments with fewer side effects. Additionally, the flexibility of the trial to include various tumor types in Phase 2 suggests that NUV-1511 might be applicable to a wide range of cancers, making it a versatile option in oncology.

What evidence suggests that NUV-1511 might be an effective treatment for solid tumors?

Research shows that NUV-1511 is a new treatment under testing for advanced solid tumors. Early studies suggest promise because NUV-1511 targets cancer cells uniquely. The FDA has approved it for investigational use, indicating potential in initial studies. Detailed information from human trials remains limited, but the treatment is designed to specifically attack tumor cells, offering hope for those with advanced cancers. Early signs suggest effectiveness, but further trials are necessary to confirm this. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

My advanced cancer has not responded to standard treatments.

I have a specific type of cancer like HER2- breast cancer, mCRPC, pancreatic, or PROC.

Exclusion Criteria

I have recently undergone chemotherapy, hormonal, radiation, or biological therapy for cancer.

I have had a major surgery recently.

I have an autoimmune disease or a condition that weakens my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Treatment

Participants receive escalating doses of NUV-1511 to determine safety and tolerability

4 weeks

Periodic visits for dose escalation and monitoring

Phase 2 Treatment

Participants receive the recommended Phase 2 dose of NUV-1511 to evaluate efficacy

Up to 5 years

Periodic efficacy assessments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NUV-1511

Trial Overview 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.

How Is the Trial Designed?

Group I: Phase 2: Tumor Type 2 Experimental Treatment 1 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 1 Experimental Treatment 1 Intervention

Tumor type to be selected after Phase 1. Dose Schedules A and B to be further evaluated.

Group III: Phase 2: All comers Experimental Treatment 1 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 B Experimental Treatment 1 Intervention

Schedule B evaluating escalating dose levels of NUV-1511

Group V: Phase 1: Schedule A Experimental Treatment 1 Intervention

Schedule A evaluating escalating dose levels of NUV-1511

Who Is Running the Clinical Trial?

Nuvation Bio Inc.

Lead Sponsor

Trials

12

Recruited

1,200+

Published Research Related to This Trial

The study determined that the combination of intravenous irinotecan and oral S-1 is a tolerable treatment for advanced or recurrent cervical cancer, with a recommended dose of 80 mg/m for S-1 and 150 mg/m for irinotecan.

Out of 12 patients treated, only one experienced a dose-limiting toxicity (DLT) of febrile neutropenia at the second dose level, indicating that the regimen has an acceptable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Clinical Study of Irinotecan Plus S-1 in Patients With Advanced or Recurrent Cervical Cancer Previously Treated With Platinum-Based Chemotherapy. Mabuchi, S., Yokoi, E., Owa, T., et al.[2018]

In a study of 90 patients with advanced solid tumors treated with PD-1/PD-L1 inhibitors, the objective response rate was 25.6%, with a median progression-free survival of 5.5 months and median overall survival of 16.9 months, indicating promising efficacy.

Clinical factors such as ECOG performance status, smoking status, liver metastasis, and neutrophil-to-lymphocyte ratio were found to significantly influence progression-free survival, while liver metastasis and lactate dehydrogenase levels were linked to overall survival.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical observation of the efficacy of PD-1/PD-L1 inhibitors in the treatment of patients with advanced solid tumors. Wang, M., Zhen, H., Jiang, X., et al.[2021]

A systematic review of 12 randomized controlled trials involving 5410 participants showed that PD-1/PD-L1 inhibitor-chemotherapy combinations significantly improve overall survival (OS) and progression-free survival (PFS) in patients with non-small cell lung cancer (NSCLC) that have less than 1% PD-L1 expression.

Patients with negative PD-L1 expression (38.9% of the study population) experienced a notable benefit from these combination therapies, achieving better objective response rates compared to standard chemotherapy alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PD-1/PD-L1 inhibitors in treatment-naïve, advanced non-small cell lung cancer patients with Wankhede, D., Hofman, P., Grover, S.[2023]

In a systematic review of 24 randomized trials involving 12,966 participants, PD-1/PD-L1 inhibitors significantly improved overall survival (OS) in both PD-L1-positive (HR 0.65) and PD-L1-negative (HR 0.82) patients, indicating their efficacy across different PD-L1 statuses.

The study found a positive dose-response relationship between PD-L1 positivity and OS benefit, suggesting that higher levels of PD-L1 expression correlate with greater survival advantages from these inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of PD-L1 expression status with the efficacy of PD-1/PD-L1 inhibitors and overall survival in solid tumours: A systematic review and meta-analysis. Liu, X., Guo, CY., Tou, FF., et al.[2021]

VX15/2503 was well tolerated in a study of 42 patients with advanced solid tumors, with most side effects being mild (grade 1 or 2), such as nausea and fatigue, indicating a favorable safety profile.

The treatment showed promising antitumor activity, with one patient achieving a partial response and 45.2% of patients maintaining stable disease for at least 8 weeks, suggesting that VX15/2503 may enhance immune response against tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Pharmacokinetics, and Pharmacodynamics of a Humanized Anti-Semaphorin 4D Antibody, in a First-In-Human Study of Patients with Advanced Solid Tumors. Patnaik, A., Weiss, GJ., Leonard, JE., et al.[2022]

In a systematic review of 24 trials involving over 14,860 patients, PD-1/PD-L1 inhibitors significantly reduced the risk of death compared to conventional treatments, with a hazard ratio of 0.72, indicating a strong efficacy across various tumor types.

Patients with positive PD-L1 expression (≥1%) showed improved overall survival when treated with anti-PD-1/PD-L1 monotherapy, particularly in nonsmall cell lung cancer, suggesting that PD-L1 expression can be a useful biomarker for selecting patients for this type of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Value of PD-L1 Expression in Predicting the Efficacy of Anti-PD-1 or Anti-PD-L1 Therapy in Patients with Cancer: A Systematic Review and Meta-Analysis. Chen, XJ., Yuan, SQ., Duan, JL., et al.[2022]

The alpha(nu)beta(3) integrin inhibitor MK-0429 was generally well tolerated in a study of 21 men with hormone-refractory prostate cancer and bone metastases, with nausea being the most common side effect.

After 4 weeks of treatment, MK-0429 showed a significant reduction in bone turnover markers, suggesting potential clinical benefits, although there was an unexpected increase in serum prostate-specific antigen (PSA) levels, indicating disease activity may not have improved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the safety, pharmacokinetics and treatment effects of an alpha(nu)beta(3) integrin inhibitor on bone turnover and disease activity in men with hormone-refractory prostate cancer and bone metastases. Rosenthal, MA., Davidson, P., Rolland, F., et al.[2010]

The combination of tumor vasculature-targeted gene therapy (AAVP-TNF-α) and the IAP antagonist LCL161 significantly inhibited tumor growth and improved survival in mice with melanoma, demonstrating enhanced antitumor efficacy.

This combination therapy was more effective than using either treatment alone and did so without causing systemic toxicity, indicating a promising approach for melanoma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blockade of inhibitors of apoptosis (IAPs) in combination with tumor-targeted delivery of tumor necrosis factor-α leads to synergistic antitumor activity. Yuan, Z., Syrkin, G., Adem, A., et al.[2021]

In a study of 277 patients with non-small cell lung cancer (NSCLC) who underwent surgery, PD-L1 expression was found to influence tumor-specific survival (TSS), with lower survival rates in patients with higher PD-L1 levels after adjuvant therapy.

Patients with PD-L1 negative tumors had better survival outcomes following adjuvant chemotherapy compared to those with PD-L1 positive tumors, particularly in adenocarcinoma cases, suggesting that PD-L1 assessment could help tailor treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prognostic Impact of PD-L1 Expression in pN1 NSCLC: A Retrospective Single-Center Analysis. Eichhorn, F., Kriegsmann, M., Klotz, LV., et al.[2021]

ODX, a novel bone-targeting drug for castration-resistant prostate cancer, was well tolerated and showed inhibitory effects on bone metabolism markers, indicating potential efficacy in reducing metastatic burden.

In a study of 55 patients receiving different doses of ODX, significant decreases in bone alkaline phosphatase and serum-aminoterminal-propeptide of Type I procollagen were observed, suggesting that ODX may effectively target bone metastases without serious adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised, double-blind, dose-finding, phase II multicentre study of ODX in the treatment of patients with castration-resistant prostate cancer and skeletal metastases. Thellenberg-Karlsson, C., Vjaters, E., Kase, M., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06334432

Safety and Efficacy Study of NUV-1511 in Adult Patients ... 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.

2. targetedonc.com targetedonc.com/view/fda-clears-ind-of-nuv-1511-for-advanced-solid-tumors

FDA Clears IND of NUV-1511 for Advanced Solid Tumors NUV-1511, a novel drug candidate for the treatment of solid tumors, has received clearance from the FDA for its investigational new drug application.

3. investors.nuvationbio.com investors.nuvationbio.com/news/news-details/2024/Nuvation-Bio-Doses-First-Patient-in-Phase-12-Study-of-NUV-1511-for-the-Treatment-of-Advanced-Solid-Tumors/default.aspx

Nuvation Bio Doses First Patient in Phase 1/2 Study of ... The first patient has been dosed in a Phase 1/2 study of NUV-1511, the Company's first DDC to enter the clinic.

4. cancernetwork.com cancernetwork.com/view/fda-clears-application-for-nuv-1511-for-advanced-solid-tumors

FDA Clears Application for NUV-1511 for Advanced Solid ... Plans have been put in place to launch a phase 1/2 study assessing NUV-1511 in a population of patients with advanced solid tumors.

5. fredhutch.org fredhutch.org/en/research/clinical-trials/trial-details.fh_trial_id_15146.safety-and-efficacy-study-of-nuv-1511-in-adult-patients-with-advanced-solid-tumors.html

Safety and Efficacy Study of NUV-1511 in Adult Patients ... 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.