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Unknown

NB004 for Solid Tumors

Phase 1
Recruiting
Research Sponsored by Ningbo Newbay Technology Development Co., Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically and/or cytologically confirmed diagnosis of advanced solid tumors without standard treatment options (part 1)
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months since the first subject enrolled
Awards & highlights

Study Summary

This trial is testing a new drug to treat advanced solid tumors. Researchers will study how well the drug works and how safe it is.

Who is the study for?
This trial is for adults (18+) with advanced solid tumors lacking standard treatment options. Participants must have a performance status indicating they are fully active or restricted in physically strenuous activity but ambulatory, measurable disease, and an expected lifespan of at least 12 weeks. They should not have had cancer therapy within the last 2-3 weeks and must not be pregnant or planning pregnancy.Check my eligibility
What is being tested?
The study tests NB004 tablets as a single agent or combined with other therapies in patients with advanced solid tumors. It's an early-phase trial (Phase 1) focusing on safety, how well the body tolerates it, and how the drug behaves inside the body (pharmacokinetics).See study design
What are the potential side effects?
While specific side effects of NB004 are not listed here, typical Phase 1 trials may observe fatigue, nausea, diarrhea, skin reactions among others depending on the drug's action mechanism. Close monitoring will identify any potential adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer has no standard treatment options.
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I am fully active or can carry out light work.
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My cancer has a KRAS G12C mutation.
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My cancer can be measured or seen on tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 24 months since the first subject enrolled
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months since the first subject enrolled for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Benefit Rate (CBR) ----Part 3
Duration of Response (DOR) ----Part 3
Incidence of adverse events----Part 1/2
+5 more
Secondary outcome measures
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t) ----Part 1
Clinical Benefit Rate (CBR) ----Part 2
Duration of Response(DOR)----Part 2
+7 more

Side effects data

From 2022 Phase 1 trial • 20 Patients • NCT04887064
14%
Constipation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Normal Hepatic Function
Moderate Hepatic Impairment
Severe Hepatic Impairment

Trial Design

1Treatment groups
Experimental Treatment
Group I: NB004Experimental Treatment1 Intervention
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:

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Who is running the clinical trial?

Ningbo Newbay Technology Development Co., LtdLead Sponsor
1 Previous Clinical Trials
258 Total Patients Enrolled

Media Library

NB004 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05036291 — Phase 1
Solid Tumors Research Study Groups: NB004
Solid Tumors Clinical Trial 2023: NB004 Highlights & Side Effects. Trial Name: NCT05036291 — Phase 1
NB004 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05036291 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what degree can NB004 tablets be hazardous to those administering it?

"Our team at Power gauged the safety of NB004 tablets to be a 1, as this is an initial Phase 1 trial with only limited data available backing its efficacy and security."

Answered by AI

Is the recruitment process for this trial still in effect?

"Correct. According to the clinicaltrials.gov listing, this medical trial is presently searching for eligible participants; it was initially published on October 1st 2021 and has since been updated on October 14th 2021. The experiment requires 36 patients across 2 sites."

Answered by AI

What is the primary aim of this exploration?

"This 24 month trial is evaluating the incidence of dose-limiting toxicities. Additionally, secondary objectives include assessing a patient's response as either complete or partial (ORR) and quantifying Area Under Curve from time zero to last measurable concentration AUC(0-t), as well as Maximum Observed Plasma Concentration Cmax)."

Answered by AI

How many subjects are participating in the exploration?

"Correct. According to the clinicaltrials.gov portal, this medical research trial - which was posted on October 1st 2021 - is currently seeking participants. This study requires 36 volunteers from 2 distinct sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors
2021. "A Study of NB004 as Monotherapy or Combination Therapy in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05036291.
~27 spots leftby Feb 2025
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