RecruitingPhase 1NCT05036291

A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors

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

Sponsor

Ningbo Newbay Technology Development Co., Ltd

Enrollment

120 participants

Start Date

Oct 1, 2021

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor

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

Eligibility

Min Age: 18 Years

Inclusion Criteria7

males or females of any race>(=)18 years age.
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).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Life expectancy>(=)12 weeks.
Adequate organ and marrow function.
Measurable or evaluable disease.

Exclusion Criteria7

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.
Toxicities from previous anti-cancer therapy that have not recovered as required.
Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis.
Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV):
Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose.
Male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose.
Received prior treatment with a PIM kinase inhibitor.

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Interventions

DRUGNB004 tablets

Part1: Dose escalation phase of study drug NB004 monotherapy: Drug: NB004 tablets NB004 tablets will be administered orally once daily for repeated 28-day cycles until discontinuation criteria are met. Part 2: Dose Escalation Phase/ COMBO Dose Expansion Phase for the NB004 in combination with Sotorasib: Drug: NB004 tablets \& Sotorasib NB004 tablets will be administered orally once a daily for repeated 21-day cycles until discontinuation criteria are met. Sotorasib will be administered with the recommended dosage per prescribing information approved by the FDA Part 3: Dose Escalation Phase/ COMBO Dose Expansion Phase for the NB004 in combination with Sotorasib: Drug: NB004 tablets \& Sotorasib NB004 tablets will be administered orally once daily for repeated 21-day cycles until discontinuation criteria are met. Sotorasib will be administered with the recommended dosage per prescribing information approved by the FDA .