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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06334432
Other study ID # NUV-1511-01
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 14, 2024
Est. completion date October 2027

Study information

Verified date June 2024
Source Nuvation Bio Inc.
Contact Nuvation Bio
Phone 332-208-6102
Email clinicaltrials@nuvationbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 466
Est. completion date October 2027
Est. primary completion date March 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Phase 1 Dose Escalation cohorts, Phase 1 Backfill cohorts, and Phase 2 Tumor Type-Specific cohort(s): must meet one of the following criteria: - HER2- metastatic breast cancer: 1. Hormone refractory hormone receptor positive metastatic breast cancer with progression on or after treatment with CDK4/6 inhibitor plus at least one line of systemic chemotherapy in the advanced setting 2. Triple negative metastatic breast cancer with progression after at one line of systemic chemotherapy in the advanced setting. - Patients with advanced solid tumors that progressed on or following treatment with Enhertu and/or Trodelvy per label - mCRPC: Histologically confirmed, metastatic castration resistant adenocarcinoma of the prostate 1. May have received up to 2 prior chemotherapies in mCRPC setting 2. Prior therapy with PARP (poly-ADP ribose polymerase) inhibitor, PLUVICTO, Radium-223, or Provenge is allowed - Pancreatic cancer: PDAC (pancreatic ductal adenocarcinoma) with progression on or after treatment with at least one line of systemic chemotherapy in the advanced setting. - PROC: Histologically or cytologically confirmed platinum-resistant high-grade serous ovarian, fallopian, or primary peritoneal cancer; - Phase 1 Dose Escalation cohorts, Phase 1 Backfill cohorts, and Phase 2 Tumor Type-Specific cohorts (except mCRPC; see inclusion criterion 2 above): must have measurable disease per RECIST 1.1 - Phase 2 All Comers cohort: Patients with advanced solid tumors that have progressed during or after treatment with approved therapies or for whom there is no standard effective therapy available. - Adequate bone marrow and organ function. - Provide informed consent, which includes compliance with protocol-specified requirements and restrictions Exclusion Criteria: - Chemotherapy, hormonal therapy (with the exception of ongoing luteinizing hormone-releasing hormone analogs in male patients and premenopausal females), radiation therapy, or biological anticancer therapy within 14 days before the first dose of study treatment - Treatment with an investigational agent for any indication within 14 days before the first dose of study treatment for non-myelosuppressive agent, or within 21 days or <5 half-lives before the first dose of study treatment, whichever is longer, for a myelosuppressive agent - Ongoing or active infection requiring systemic therapy, or an infection requiring hospitalization or intravenous therapy within 2 weeks before the first dose of study treatment - Resting left ventricular ejection fraction (LVEF) of <50% obtained by echocardiography or multigated acquisition scan (MUGA) - History of significant cardiac disease, including myocardial infarction, New York Heart Association Class II/III/IV heart failure, unstable angina, unstable cardiac arrhythmias (eg, ventricular tachycardia, ventricular fibrillation), syncope of cardiovascular etiology, or cardiac arrest: - Known immunosuppressive disease or active systemic autoimmune disease such as systemic lupus erythematosus, human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infections not currently controlled by current disease-specific therapy. The following exceptions apply: - Major surgical procedure within 2 weeks before the first dose of study treatment, or an anticipated need for major surgery during the course of the study - Other cancer within 2 years before the first dose of study treatment with metastatic or local recurrence potential that could negatively impact survival and/or potentially confound tumor response assessments. Patients with a history of other cancers in the past 2 years should be discussed with the Medical Monitor. - Female patients who are pregnant or breastfeeding

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
NUV-1511
Novel small molecule

Locations

Country Name City State
United States Karmanos Cancer Center Detroit Michigan
United States NEXT Oncology Fairfax Virginia
United States Carolina BioOncology Institute Huntersville North Carolina
United States NEXT Oncology Irving Texas
United States Memorial Sloan-Kettering Cancer Center New York New York
United States START Mountain Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
Nuvation Bio Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis Blood sample for exploratory analysis of circulating DNA 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
Other Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis Blood sample for exploratory analysis of gene expression (including that of hormone receptors and efflux transporters) 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
Other Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity Tumor biopsy for exploratory analysis of tumor genome 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
Other Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity Tumor biopsy for exploratory analysis of epigenome 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
Other Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity Tumor biopsy for exploratory analysis of gene expression 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
Other Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity Identification of genetic factors that predict toxicity Blood and tumor biopsy collection at the time of enrollment
Other Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity Identification of genetic factors that predict anti-tumor activity Blood and tumor biopsy collection at the time of enrollment
Other Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity Identification of genetic factors that predict metabolism of NUV-1511 Blood and tumor biopsy collection at the time of enrollment
Other Evaluate drug exposure-response relationship PK exposure response modeling which includes measuring PK exposure versus efficacy Periodic PK sample collection through disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Other Evaluate drug exposure-response relationship PK exposure response modeling which includes measuring PK exposure versus safety Periodic PK sample collection through disease progression, withdrawal of consent, or initiation of subsequent anticancer treatment or up to a period of 5 years, whichever occurs first
Primary 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 First 28 days of dosing (DLT evaluation period)
Primary 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 First 28 days of dosing (DLT evaluation period)
Primary 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 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
Primary 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) 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
Primary 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) 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
Secondary 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. 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
Secondary 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. 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
Secondary 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. 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
Secondary Characterize the PK profile of NUV-1511 Parameters include, but not limited to, maximum observed plasma concentration (Cmax) 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.
Secondary Characterize the PK profile of NUV-1511 Parameters include, but not limited to, area under the plasma concentration-time curve (AUC) 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.
Secondary Phase 2: Further evaluate the safety and efficacy of NUV-1511 Incidence of TEAEs and SAEs 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
Secondary Phase 2: Further evaluate the safety and efficacy of NUV-1511 Laboratory abnormalities 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
Secondary Phase 2: Further evaluate the safety and efficacy of NUV-1511 Duration of response 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
Secondary Phase 2: Further evaluate the safety and efficacy of NUV-1511 Clinical best response 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
Secondary Phase 2: Further evaluate the safety and efficacy of NUV-1511 Progression free survival 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
Secondary Phase 2: Further evaluate the safety and efficacy of NUV-1511 Overall survival 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
Secondary Phase 2: Further evaluate the safety and efficacy of NUV-1511 PK exposure-response modeling, which includes measuring plasma concentration versus overall response rate 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
Secondary Phase 2: Further evaluate the safety and efficacy of NUV-1511 PK exposure-response modeling, which includes measuring plasma concentration versus progression free survival 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
Secondary 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. 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
Secondary Phase 2: Further evaluate the safety and efficacy of NUV-1511 Response rates in disease-specific markers 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
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