NPX887 for Cancer

Recruiting at 11 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called NPX887, designed to help the immune system combat certain types of cancer. Researchers aim to determine NPX887's safety, effectiveness, and potential side effects. Individuals with specific cancers, such as lung, kidney, or ovarian cancer, that have not responded to standard treatments might be suitable candidates. The trial involves receiving NPX887 through an IV every three weeks, with close monitoring by doctors. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that NPX887 is likely to be safe for humans?

Research has shown that NPX887 is in the early stages of testing to assess its safety for people. Researchers are evaluating how well participants tolerate it and identifying potential side effects. As NPX887 is being used in humans for the first time, researchers closely monitor participants to gather safety information. The main goal is to identify any serious side effects and determine the correct dose. Although specific safety information is not yet available, the trial aims to ensure that any side effects remain manageable for participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

NPX887 is unique because it targets cancer cells by a different mechanism than most existing treatments. While traditional cancer therapies often involve chemotherapy that attacks both healthy and cancerous cells, NPX887 is designed to specifically target and disrupt the growth of cancer cells, potentially sparing healthy cells. Researchers are excited about NPX887 because it is delivered through an intravenous infusion every three weeks, which might improve patient convenience and adherence compared to more frequent dosing schedules. This targeted approach and less frequent administration could mean fewer side effects and better quality of life for patients.

What evidence suggests that NPX887 might be an effective treatment for cancer?

Research has shown that NPX887 targets a protein called B7-H7, linked to worse outcomes in cancer patients. By blocking this protein, NPX887 aims to enhance the body's immune response against tumors. Early studies suggest this method could help slow tumor growth, although detailed results are still being gathered. Participants in this trial will receive NPX887 by IV infusion every three weeks. While this treatment is new and under close study, it shows promise for cancers with B7-H7. ^{1 2 5 6 7}

Who Is on the Research Team?

Leena Gandhi, MD, PhD

Principal Investigator

NextPoint

Are You a Good Fit for This Trial?

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

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

Willing to use highly effective contraceptive measures throughout the trial

My disease can be measured by standard imaging methods.

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06240728

A Study of NPX887 for Participants With Solid Tumors ... Throughout the study, safety and preliminary efficacy data will be collected to characterize the clinical activity of NPX887. Samples of blood will be taken to ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-01335

A Study of NPX887 for Participants With Solid Tumors ... 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) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11083681/

Prognostic Value of HHLA2 in Patients with Solid Tumors The current study suggests that high expression of HHLA2 is associated with poorer prognosis in patients with solid cancers.

4. trials-api.montefioreeinstein.org trials-api.montefioreeinstein.org/index.php/node/408956

A Study of NPX887 for Participants With Solid Tumors Known to ... 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) ...

5. clinicaltrialsarena.com clinicaltrialsarena.com/news/nextpoint-solid-tumour-trial/

NextPoint doses first subject in Phase I solid tumour ... The trial will assess the safety, immunogenicity, efficacy, and biomarker-based selection of NPX887 for various solid tumours. February 21 ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02647-4/fulltext

1070TiP A phase Ia/Ib dose-escalation/expansion study of ... NPX887 is being studied in a phase 1a/1b study in solid tumor malignancies where B7-H7 is known to be expressed.

7. synapse.patsnap.com synapse.patsnap.com/blog/nextpoint-therapeutics-begins-clinical-trial-for-npx887-targeting-hhla2-solid-tumors

NextPoint Therapeutics Begins Clinical Trial for NPX887 ... The therapeutic agent NPX887 is designed as a fully humanized monoclonal antibody centered on HHLA2 (B7-H7), an emerging immune checkpoint and ...