NPX887 for Cancer

Recruiting at 6 trial locations

Overseen By Lauren Doherty

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: NextPoint Therapeutics, Inc.

Must not be taking: Immunosuppressants, others

Disqualifiers: Brain metastases, autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

144 Participants Needed

Trial Summary

What is the purpose of this trial?

NPX887 is a human, antagonistic immunoglobulin G1 (IgG1) monoclonal antibody targeting B7-H7 (HHLA2) that may potentiate an anti-tumor immune response. The goal of this first-in-human study is to learn whether NPX887 is safe and tolerable and shows a preliminary efficacy in participants with B7-H7 (HHLA2) expressing tumors at selected dose(s). The main questions it aims to answer are: * what is an appropriate dose to be given to participants? * are the side effects of treatment manageable? * what is the preliminary anti-tumor activities? Participants who are treated will receive an intravenous (IV) infusion of NPX887 if their disease has not progressed, and be closely monitored by the treating physicians.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had systemic anticancer treatment within 14 days or within 5 half-lives before starting the study drug, whichever is shorter.

Research Team

Leena Gandhi, MD, PhD

Principal Investigator

NextPoint

Eligibility Criteria

This trial is for individuals with solid tumors that test positive for a protein called HHLA-2/B7-H7. Specific eligibility details are not provided, but typically participants must be in good health aside from their cancer and meet certain medical criteria.

Inclusion Criteria

My disease can be measured by standard imaging methods.

Ability to understand and the willingness to sign a written informed consent document

Willing to use highly effective contraceptive measures throughout the trial

Exclusion Criteria

I take more than 10 mg of prednisone daily for an autoimmune disease.

I haven't had cancer treatment in the last 14 days.

I had focused radiotherapy less than a week ago or broader chest radiotherapy less than 8 weeks ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Phase 1a: Dose Escalation

Participants receive escalating doses of NPX887 to determine the optimal dose

21 days per cycle, up to 24 months

Every 3 weeks (in-person)

Phase 1b: Dose Expansion

Participants receive NPX887 at selected doses to evaluate preliminary activities in multiple disease-specific cohorts

21 days per cycle, up to 24 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

1 visit (in-person)

Treatment Details

Interventions

• NPX887

Trial Overview The study is testing NPX887, an antibody designed to boost the immune system's response against cancer by targeting the HHLA-2/B7-H7 protein on tumor cells. It's given as an IV infusion and doctors will determine the best dose while monitoring safety.

Participant Groups

Group I: NPX887 Treatment Experimental Treatment 1 Intervention

Participants will receive NPX887 by IV infusion every 3 weeks.

Who Is Running the Clinical Trial?

NextPoint Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

280+