What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, targeted therapy, and immunotherapy, are associated with a range of side effects. Chemotherapy agents like gemcitabine and nab-paclitaxel often cause neutropenia, fatigue, neuropathy, and gastrointestinal issues. Targeted therapies can lead to skin rash, hypertension, and liver toxicity. Immunotherapies, such as checkpoint inhibitors like pembrolizumab, may result in immune-related adverse events including colitis, pneumonitis, and endocrinopathies. Monitoring for both common and unique side effects is crucial, especially for investigational treatments like NB003.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of solid tumors, including targeted therapies like pembrolizumab (an anti-PD-1 antibody) and nivolumab (another anti-PD-1 antibody), which enhance the immune system's ability to fight cancer. Additionally, chemotherapeutic agents such as paclitaxel and cisplatin are commonly used. Targeted therapies like bevacizumab, which inhibits angiogenesis, and erlotinib, which targets the EGFR pathway, have also been approved. These treatments are often used in various combinations to improve efficacy and manage advanced malignancies.

What other types of research exist?

Promising novel alternatives to NB003 for solid tumor patients include: 1) Pembrolizumab (Keytruda) combined with chemotherapy, which has shown efficacy in non-small cell lung cancer (NSCLC) as per the KEYNOTE-189 trial. 2) Atezolizumab (Tecentriq) combined with chemotherapy, which has demonstrated positive outcomes in NSCLC and other solid tumors. 3) Cabozantinib (Cabometyx), a tyrosine kinase inhibitor, effective in medullary thyroid cancer and other solid tumors. 4) Futibatinib, an FGFR inhibitor, showing promise in cholangiocarcinoma with FGFR2 fusions/rearrangements. These therapies have demonstrated significant clinical benefits and are considered promising for treating various solid tumors.

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NB003 for Solid Cancer

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

For dose escalation phase: GIST patients must have progressed on or had an intolerability to imatinib and other SoCs or refused other SoCs. Patients with an advanced solid tumor other than GIST must have relapsed or had refractory disease without an available effective therapy and harbor KIT or PDGFRα gene alterations (central laboratory confirmation is not required for screening). For dose expansion phase: Cohort 1: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to at least imatinib, sunitinib, regorafenib and ripretinib (≥ fifth line therapy setting); Cohort 2a: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to imatinib and sunitinib, and who have not received additional systemic therapy for advanced GIST (third line therapy setting); Cohort 2b: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to imatinib, sunitinib and regorafenib, and who have not received additional systemic therapy for advanced GIST (forth line therapy setting); Cohort 3: GIST patients with KIT or PDGFRα gene mutations, must have progressed on or been intolerant to imatinib and have not received additional systemic therapy for advanced GIST (second line therapy setting); Cohort 4: GIST patients with PDGFRα exon 18 mutation and must have progressed on or been intolerant to avapritinib; in the countries/regions where avapritinib is not SoC, avapritinib-naïve patients can be enrolled; Cohort 5: Unresectable or metastatic melanoma patients with demonstrated evidence for KIT gene mutation and/or amplification, must have progressed on or been intolerant to SoCs; Cohort 6: Patients with other advanced malignancies other than GIST or melanoma which must be relapsed or refractory without an available effective therapy and harbor KIT or PDGFRα gene alterations. For dose expansion phase: at least one measurable lesion per RECIST v1.1/mRECIST

Tumor sample collection is required

Must not have

Major surgery within 4 weeks of the first dose

Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum wash-out period of 21 days prior to the initiation of study drug administration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 24 months since the escalation first subject enrolled; approximately 26 months since the expansion first subject enrolled

Awards & highlights

No Placebo-Only Group

Summary

This trial tests NB003, a new drug, for safety and behavior in patients with advanced cancers who have limited treatment options. It targets specific genetic changes in cancer cells to potentially stop or slow down their growth.

Who is the study for?

Adults over 18 with advanced solid tumors, particularly GIST or those with KIT/PDGFRα gene alterations who've exhausted standard treatments. They should have a life expectancy of at least 12 weeks, good performance status (able to carry out daily activities), and proper organ/marrow function. Can't join if they've had recent cancer therapy, major surgery, CNS metastases, active infections like hepatitis/HIV, severe diseases that could affect the trial's safety or results.

What is being tested?

The study is testing NB003 tablets on patients with advanced malignancies to evaluate their safety and how the body processes them. It's an early-phase trial (Phase 1) where everyone gets NB003; there are no comparison groups. The trial has two parts: dose escalation to find the right dose and expansion to test it further in specific patient groups.

What are the potential side effects?

Since this is a Phase 1 trial primarily assessing safety and tolerability, detailed side effects of NB003 aren't listed yet. Generally, such trials look for any adverse reactions ranging from mild symptoms like nausea to more serious ones affecting organ functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have provided a sample of my tumor for testing.

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My cancer is advanced and cannot be removed by surgery.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had major surgery in the last 4 weeks.

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I haven't had cancer treatment in the last 2-3 weeks.

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I am not taking any strong CYP3A4 inhibitors or inducers.

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I do not have active brain metastases, meningitis, hepatitis B, hepatitis C, or HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24 months since the escalation first subject enrolled; approximately 26 months since the expansion first subject enrolled

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 24 months since the escalation first subject enrolled; approximately 26 months since the expansion first subject enrolled

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months since the escalation first subject enrolled; approximately 26 months since the expansion first subject enrolled for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Incidence of dose-limiting toxicities

Secondary study objectives

Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)

Duration of Response(DOR)

Maximum observed plasma concentration (Cmax)

+3 more

Other study objectives

Cancer relevant gene mutations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation Phase and Dose Expansion PhaseExperimental Treatment1 Intervention

Dose escalation cohort: NB003 tablets will be administered orally twice daily for repeated 28-day cycles until discontinuation criteria are met. RP2D: one or more putative RP2D(s) will be explored in dose escalation phase with approximately 15 patients for each provisional RP2D(s) Dose expansion phase: In the dose expansion phase, additional patients will be enrolled at RP2D to further explore the safety, tolerability, PK, efficacy and biological activity of NB003 in specific disease cohorts, including GIST and other malignancies harboring genomic alterations of KIT or PDGFRα.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy targets rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies focus on specific molecular targets associated with cancer, such as HER2 in breast cancer, aiming to block cancer growth and spread while minimizing damage to normal cells. Immunotherapy leverages the body's immune system to recognize and attack cancer cells, often by inhibiting checkpoints that prevent immune cells from attacking tumors. These mechanisms are crucial for solid tumor patients as they offer different approaches to control or eliminate tumors, potentially improving survival rates and quality of life.

Current trends and future directions in the genetic therapy of human neoplastic disease.