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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: Schedule A | Other | Schedule A evaluating escalating dose levels of NUV-1511 |
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| Phase 1: Schedule B | Other | Schedule B evaluating escalating dose levels of NUV-1511 |
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| Phase 2: Tumor Type 1 | Experimental | Tumor type to be selected after Phase 1. Dose Schedules A and B to be further evaluated. |
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| Phase 2: Tumor Type 2 | Experimental | 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. |
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| Phase 2: All comers | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NUV-1511 | Drug | Novel small molecule |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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:
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
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karmanos Cancer Center | Detroit | Michigan | 48201 | United States | ||
| Hackensack University Medical Center |
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| 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 |
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Hackensack |
| New Jersey |
| 07601 |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Carolina BioOncology Institute | Huntersville | North Carolina | 28078 | United States |
| NEXT Oncology | Irving | Texas | 75038 | United States |
| START Mountain | Salt Lake City | Utah | 84124 | United States |
| NEXT Oncology | Fairfax | Virginia | 22031 | United States |
| Fred Hutchinson | Seattle | Washington | 98109 | United States |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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