Advanced Solid Tumor Clinical Trial
Official title:
A Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects With Advanced Solid Tumors
This is a Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors
Status | Recruiting |
Enrollment | 120 |
Est. completion date | June 1, 2025 |
Est. primary completion date | February 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. males or females of any race>(=)18 years age. 2. Histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options (part 1). Pathologically confirmed locally advanced or metastatic solid tumors with KRAS G12C mutation as determined by a test that has been approved by FDA or local health authority (part 2&3). 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Life expectancy>(=)12 weeks. 5. Adequate organ and marrow function. 6. Measurable or evaluable disease. Exclusion Criteria: 1. Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum of 3 weeks, before the first dose. 2. Toxicities from previous anti-cancer therapy that have not recovered as required. 3. Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis. 4. Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV): 5. Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose. 6. Male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose. 7. Received prior treatment with a PIM kinase inhibitor. |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Providence Cancer Institute | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Ningbo Newbay Technology Development Co., Ltd |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of dose-limiting toxicities----Part 1/2 | Dose-limiting toxicities will be reviewed as a subset of adverse events that occurs within the first 28 days of dosing and meet protocol-specified criteria. | When subject complete 1 cycle (28 days) treatment with safety and tolerability assessment by investigators. | |
Primary | Incidence of adverse events----Part 1/2 | An adverse event is any untoward medical occurrence in a participant who received study drug without regard to causal relationship. | Approximately 24 months since the first subject enrolled | |
Primary | Objective Response Rate (ORR) ----Part 3 | Objective Response Rate (ORR) is defined as the percentage of patients whose efficacy is confirmed as complete response (CR) or partial response (PR) | [Time Frame: Approximately 24 months since the first subject enrolled] | |
Primary | Duration of Response (DOR) ----Part 3 | DOR is defined as the time from the date of first documented response until date of documented progression, for subjects who achieve CR or PR. | [Time Frame: Approximately 24 months since the first subject enrolled] | |
Primary | Time to Response (TTR) ----Part 3 | TTR is defined as the time interval between the date of first administration and the date of the first recording of response. At the same time, the initial response time and the time to best response will be calculated. | [Time Frame: Approximately 24 months since the first subject enrolled] | |
Primary | Progression-free Survival (PFS) ----Part 3 | PFS is defined as the time from the date of the first dose until the date of disease progression, as defined by RECIST v1.1, or death. | [Time Frame: Approximately 24 months since the first subject enrolled] | |
Primary | Clinical Benefit Rate (CBR) ----Part 3 | CBR is defined as the number of subjects with CR or PR or with SD maintained =24 weeks (as assessed by the Investigator, using RECIST v1.1) divided by the number of subjects in the analysis. Subjects without a postbaseline tumor assessment will be considered as having no clinical benefit. | [Time Frame: Approximately 24 months since the first subject enrolled] | |
Primary | Overall survival (OS) ----Part 3 | OS is defined as the time from treatment start with study drug until event of death due to any cause. | [Time Frame: Approximately 24 months since the first subject enrolled] | |
Secondary | Maximum observed plasma concentration (Cmax)----Part 1 | Maximum observed plasma concentration (Cmax) | Approximately 24 months since the first subject enrolled | |
Secondary | Time to Cmax (Tmax)----Part 1 | Time to Cmax (Tmax) | Approximately 24 months since the first subject enrolled | |
Secondary | Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) ----Part 1 | AUC (0-t) = Area under the serum concentration versus time curve from time zero (pre-dose) to the time of the last | Approximately 24 months since the first subject enrolled | |
Secondary | Terminal elimination half life----Part 1 | Terminal elimination half life | Approximately 24 months since the first subject enrolled | |
Secondary | Objective Response Rate (ORR)----Part 2 | Objective Response Rate (ORR) is defined as the percentage of patients whose efficacy is confirmed as complete response(CR) or partial responses(PR) | Approximately 24 months since the first subject enrolled | |
Secondary | Duration of Response(DOR)----Part 2 | DOR is defined as the time from the date of first documented response until date of documented progression, for subjects who achieve CR or PR. | Approximately 24 months since the first subject enrolled | |
Secondary | Clinical Benefit Rate (CBR) ----Part 2 | CBR is defined as the number of subjects with CR or PR or with SD maintained =24 weeks (as assessed by the Investigator, using RECIST v1.1) divided by the number of subjects in the analysis. Subjects without a postbaseline tumor assessment will be considered as having no clinical benefit. | [Time Frame: Approximately 24 months since the first subject enrolled] | |
Secondary | Time to Response (TTR) ----Part 2 | TTR is defined as the time interval between the date of first administration and the date of the first recording of response. At the same time, the initial response time and the time to best response will be calculated. | [Time Frame: Approximately 24 months since the first subject enrolled] | |
Secondary | Progression-free Survival (PFS) ----Part 2 | PFS is defined as the time from the date of the first dose until the date of disease progression, as defined by RECIST | [Time Frame: Approximately 24 months since the first subject enrolled] | |
Secondary | Overall survival (OS) ----Part 2 | OS is defined as the time from treatment start with study drug until event of death due to any cause | [Time Frame: Approximately 24 months since the first subject enrolled] |
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