A Study of NPX887 for Participants With Solid Tumors Known to Express B7-H7/HHLA2

Last updated: June 25, 2025
Sponsor: NextPoint Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

NPX887

Clinical Study ID

NCT06240728
NPX887-001
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed recurrent, metastatic solid tumorrefractory to, or intolerant of, standard of care therapy in one of the followingindications:

  • Phase 1a (Dose Escalation): Non-small cell lung carcinoma (NSCLC), small celllung carcinoma (SCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC),gastric and gastro-esophageal carcinoma, esophageal adenocarcinoma, biliarytract cancers, ovarian carcinoma, and other solid tumor types known to expressB7-H7/HHLA2.

  • Phase 1b including Part 1b (Dose Expansion) and Part 1c (Randomized DoseComparison): participants who have clear cell RCC, EGFR mutant lungadenocarcinoma, or gastric/GEJ adenocarcinoma.

  • In Phase 1b, participants must have confirmed B7-H7/HHLA2 expression in theirtumor determined via archival tissue IHC testing through a central lab (pre-screening).

  • Phase 1a: Evaluable disease (measurable or non-measurable) by RECIST v.1.1 criteria;Phase 1b: Measurable disease by RECIST v1.1 criteria with additionaldisease-specific enrollment criteria applied to clear cell RCC, EGFR mutant lungadenocarcinoma, or gastric/GEJ adenocarcinoma.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.

  • Ability to understand and the willingness to sign a written informed consentdocument

  • Willing to use highly effective contraceptive measures throughout the trial.

Exclusion

Exclusion Criteria:

  • Treatment with any of the following:

  • Systemic anticancer treatment ≤14 days or within 5 half-lives prior to thefirst dose of study drug, whichever is shorter.

  • Limited-field radiotherapy ≤7 days or extended-field thoracic radiotherapy ≤8weeks of the first dose of study drug.

  • Have any unresolved toxicity of ≥Grade 2 from previous anti-cancer treatment, exceptfor alopecia, chronic stable neuropathy for >4 months, changes in skin pigmentation,or requiring replacement therapy for endocrine abnormalities.

  • Participants with known brain metastases are excluded unless they are clinicallystable, with no new or enlarging brain metastases as evidenced on MRI duringscreening.

  • History of Grade 3 immune-related pneumonitis or colitis.

  • Participants who discontinued prior immunotherapy due to immune-related toxicities,or history of unresolved prior immune-related toxicity except for endocrineabnormalities requiring replacement therapy or vitiligo.

  • Known autoimmune disease requiring immunosuppressive treatment requiring theequivalent of more than 10 mg prednisone daily.

Study Design

Total Participants: 144
Treatment Group(s): 1
Primary Treatment: NPX887
Phase: 1
Study Start date:
January 22, 2024
Estimated Completion Date:
August 31, 2027

Study Description

This study is comprised of Phase 1a (Dose Escalation) and Phase 1b including Part 1b (Dose Expansion) and Part 1c (Randomized Dose Comparison). Phase 1a will test different doses of NPX887 to determine the optimal dose(s) to continue with in Phase 1b. In the Phase 1b, more participants will be tested to evaluate preliminary activities in multiple disease-specific cohorts and compare the efficacy of the higher and lower doses chosen in Phase 1a.

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 help in an understanding of how NPX887 behaves in the body by assessing the amount of drug in the blood over time, and changes in blood components. Tumor tissue samples will be collected at screening and on-treatment stages for biomarker analysis and pharmacodynamics (PD) evaluation.

Connect with a study center

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center (BIDMC)

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Albert Einstein Medical College Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Next Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • NEXT Oncology-Fairfax

    Fairfax, Virginia 22031
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.