Clinical trial NCT05036291: A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Ningbo Newbay Technology Development Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-09-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: This study is a Phase 1, open-label, multicenter study of NB004 administered orally in patients with histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are metastatic for which all standard treatment options have been given and are ineffective, or is no longer eligible for additional standard treatment options.

The study is comprised of a dose escalation phase to determine the maximum tolerated dose and the RP2D and an expansion phase to further explore the safety and preliminary antitumor activity of NB004.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of dose-limiting toxicities----Part 1/2
timeFrame: When subject complete 1 cycle (28 days) treatment with safety and tolerability assessment by investigators.
measure: Incidence of adverse events----Part 1/2
timeFrame: Approximately 24 months since the first subject enrolled
measure: Objective Response Rate (ORR) ----Part 3
timeFrame: [Time Frame: Approximately 24 months since the first subject enrolled]
measure: Duration of Response (DOR) ----Part 3
timeFrame: [Time Frame: Approximately 24 months since the first subject enrolled]
measure: Time to Response (TTR) ----Part 3
timeFrame: [Time Frame: Approximately 24 months since the first subject enrolled]
measure: Progression-free Survival (PFS) ----Part 3
timeFrame: [Time Frame: Approximately 24 months since the first subject enrolled]
measure: Clinical Benefit Rate (CBR) ----Part 3
timeFrame: [Time Frame: Approximately 24 months since the first subject enrolled]
measure: Overall survival (OS) ----Part 3
timeFrame: [Time Frame: Approximately 24 months since the first subject enrolled]
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)----Part 1
timeFrame: Approximately 24 months since the first subject enrolled
measure: Time to Cmax (Tmax)----Part 1
timeFrame: Approximately 24 months since the first subject enrolled
measure: Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) ----Part 1
timeFrame: Approximately 24 months since the first subject enrolled
measure: Terminal elimination half life----Part 1
timeFrame: Approximately 24 months since the first subject enrolled
measure: Objective Response Rate (ORR)----Part 2
timeFrame: Approximately 24 months since the first subject enrolled
measure: Duration of Response(DOR)----Part 2
timeFrame: Approximately 24 months since the first subject enrolled
measure: Clinical Benefit Rate (CBR) ----Part 2
timeFrame: [Time Frame: Approximately 24 months since the first subject enrolled]
measure: Time to Response (TTR) ----Part 2
timeFrame: [Time Frame: Approximately 24 months since the first subject enrolled]
measure: Progression-free Survival (PFS) ----Part 2
timeFrame: [Time Frame: Approximately 24 months since the first subject enrolled]
measure: Overall survival (OS) ----Part 2
timeFrame: [Time Frame: Approximately 24 months since the first subject enrolled]
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: LSU-LCMC Health Cancer Center
state: Louisiana
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Tainan
country: China
facility: National Cheng Kung University Hospital（NCKUH）
state: Taiwan
city: Yunlin
country: China
facility: National Taiwan University Hospital Yunlin Branch
state: Taiwan
Study officials:
References: