NB004 for Solid Tumors

Recruiting in Palo Alto (17 mi)

+4 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: PIM kinase inhibitors

Disqualifiers: Brain metastases, Active infection, Pregnancy, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests NB004, a new cancer drug, in patients with advanced, metastatic solid tumors who have no other treatment options. It aims to find the highest safe dose and see if the drug can help shrink tumors.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have had any anti-cancer therapy within 2 weeks or at least 5 half-lives before starting the trial.

Eligibility Criteria

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.

Inclusion Criteria

My advanced cancer has no standard treatment options.

I am fully active or can carry out light work.

I am 18 years old or older.

See 4 more

Exclusion Criteria

I am not pregnant, breastfeeding, nor planning to become pregnant soon.

I plan to try for a child within 3 months after my last treatment dose.

I still have side effects from past cancer treatments.

See 4 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation phase to determine the maximum tolerated dose and the recommended Phase 2 dose (RP2D) of NB004

Approximately 4 weeks per cycle

Multiple visits for dose escalation and monitoring

Dose Expansion

Expansion phase to further explore the safety and preliminary antitumor activity of NB004

Approximately 24 months

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 24 months

Treatment Details

Interventions

NB004 (Unknown)

Trial OverviewThe 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).

Participant Groups

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: