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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2026-09-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NB004

Part1: Dose escalation phase of study drug NB004 monotherapy:

Part 2: Dose Escalation Phase for the NB004 in combination with Sotorasib:

Part 3: COMBO Dose Expansion Phase for the NB004 in combination with Sotorasib:

Group Type EXPERIMENTAL

NB004 tablets

Intervention Type DRUG

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 .

Interventions

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NB004 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 .

Intervention Type DRUG

Other Intervention Names

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Sotorasib

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No