NB003 for Solid Cancer

Recruiting in Palo Alto (17 mi)

+69 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Ningbo Newbay Technology Development Co., Ltd

Must not be taking: CYP3A4 inhibitors, acid-reducing agents

Disqualifiers: CNS metastases, Active infection, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

You may need to stop taking certain medications before joining the trial. Specifically, you must stop any anti-cancer therapy at least 2 weeks before starting the study drug, and you cannot take medications that strongly affect the enzyme CYP3A4 or acid-reducing agents at least 2 weeks before the first dose.

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

I have provided a sample of my tumor for testing.

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

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Exclusion Criteria

I received targeted radiation for symptom relief within the last week.

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

Any evidence of severe or uncontrolled systemic diseases which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive NB003 tablets orally twice daily for repeated 28-day cycles to determine the MTD or MAD and RP2D

Approximately 24 months

Regular visits as per protocol

Dose Expansion

Additional patients are enrolled at RP2D to further explore safety, tolerability, PK, efficacy, and biological activity of NB003

Approximately 26 months

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

NB003 (Other)

Trial OverviewThe 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.

Participant Groups

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.