Advanced Solid TumorPhase 1NCT05036291
A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
A Phase 1 study testing NB004 tablets in people with Advanced Solid Tumor, run by Ningbo Newbay Technology Development Co., Ltd at 4 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- NB004 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Oct 2021to 10 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
LSU-LCMC Health Cancer Center
New Orleans, Louisiana, 70112
China2 sites
National Cheng Kung University Hospital（NCKUH）
Tainan, Taiwan, 008866
National Taiwan University Hospital Yunlin Branch
Yunlin, Taiwan, 886
About this study
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
Read the 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- NB004 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB004 tabletsDrug
Also called Sotorasib
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 .
| Study group | Role | What they receive |
|---|---|---|
| NB004 | Experimental | 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: Receives: Drug: NB004 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: When subject complete 1 cycle (28 days) treatment with safety and tolerability assessment by investigators.
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.
Measured: Approximately 24 months since the first subject enrolled
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)
Measured: [Time Frame: Approximately 24 months since the first subject enrolled]
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.
Measured: [Time Frame: Approximately 24 months since the first subject enrolled]
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.
Measured: [Time Frame: Approximately 24 months since the first subject enrolled]
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.
Measured: [Time Frame: Approximately 24 months since the first subject enrolled]
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.
Measured: [Time Frame: Approximately 24 months since the first subject enrolled]
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.
Measured: [Time Frame: Approximately 24 months since the first subject enrolled]
Secondary outcomes (10)
Maximum observed plasma concentration (Cmax)----Part 1
Maximum observed plasma concentration (Cmax)
Measured: Approximately 24 months since the first subject enrolled
Time to Cmax (Tmax)----Part 1
Time to Cmax (Tmax)
Measured: Approximately 24 months since the first subject enrolled
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
Measured: Approximately 24 months since the first subject enrolled
Terminal elimination half life----Part 1
Terminal elimination half life
Measured: Approximately 24 months since the first subject enrolled
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)
Measured: Approximately 24 months since the first subject enrolled
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.
Measured: Approximately 24 months since the first subject enrolled
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.
Measured: [Time Frame: Approximately 24 months since the first subject enrolled]
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.
Measured: [Time Frame: Approximately 24 months since the first subject enrolled]
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
Measured: [Time Frame: Approximately 24 months since the first subject enrolled]
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
Measured: [Time Frame: Approximately 24 months since the first subject enrolled]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start1 Oct 2021
- Primary completion24 Sep 2025
- Study completion10 Oct 2025
Why it stopped: Development change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo Newbay Technology Development Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036291
- Sponsor's protocol ID
- NB004-01
- Status last verified
- Apr 2026
- First submitted
- 30 Aug 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05036291
- Acronym / sponsor ID
- NB004-01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Development change
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ningbo Newbay Technology Development Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NB004 | Experimental | Drug: NB004 tabletsPart1: 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: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NB004 tabletsAlso: SotorasibPart1: 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 . | Drug | NB004 |
Primary outcome
Incidence of dose-limiting toxicities----Part 1/2
Time frame: When subject complete 1 cycle (28 days) treatment with safety and tolerability assessment by investigators.
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.
Incidence of adverse events----Part 1/2
Time frame: Approximately 24 months since the first subject enrolled
An adverse event is any untoward medical occurrence in a participant who received study drug without regard to causal relationship.
Objective Response Rate (ORR) ----Part 3
Time frame: [Time Frame: Approximately 24 months since the first subject enrolled]
Objective Response Rate (ORR) is defined as the percentage of patients whose efficacy is confirmed as complete response (CR) or partial response (PR)
Duration of Response (DOR) ----Part 3
Time frame: [Time Frame: Approximately 24 months since the first subject enrolled]
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 to Response (TTR) ----Part 3
Time frame: [Time Frame: Approximately 24 months since the first subject enrolled]
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.
Progression-free Survival (PFS) ----Part 3
Time frame: [Time Frame: Approximately 24 months since the first subject enrolled]
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.
Clinical Benefit Rate (CBR) ----Part 3
Time frame: [Time Frame: Approximately 24 months since the first subject enrolled]
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.
Overall survival (OS) ----Part 3
Time frame: [Time Frame: Approximately 24 months since the first subject enrolled]
OS is defined as the time from treatment start with study drug until event of death due to any cause.
10 secondary outcomes
Maximum observed plasma concentration (Cmax)----Part 1
Time frame: Approximately 24 months since the first subject enrolled
Time to Cmax (Tmax)----Part 1
Time frame: Approximately 24 months since the first subject enrolled
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) ----Part 1
Time frame: Approximately 24 months since the first subject enrolled
Terminal elimination half life----Part 1
Time frame: Approximately 24 months since the first subject enrolled
Objective Response Rate (ORR)----Part 2
Time frame: Approximately 24 months since the first subject enrolled
Duration of Response(DOR)----Part 2
Time frame: Approximately 24 months since the first subject enrolled
Clinical Benefit Rate (CBR) ----Part 2
Time frame: [Time Frame: Approximately 24 months since the first subject enrolled]
Time to Response (TTR) ----Part 2
Time frame: [Time Frame: Approximately 24 months since the first subject enrolled]
Progression-free Survival (PFS) ----Part 2
Time frame: [Time Frame: Approximately 24 months since the first subject enrolled]
Overall survival (OS) ----Part 2
Time frame: [Time Frame: Approximately 24 months since the first subject enrolled]
Results and safety
The study was stopped early (reason given: Development change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NB004 tablets in people with Advanced Solid Tumor, run by Ningbo Newbay Technology Development Co., Ltd at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Development change). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicities----Part 1/2 (time frame: When subject complete 1 cycle (28 days) treatment with safety and tolerability assessment by investigators.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.