NPX887 treatment for solid tumors expressing B7-H7/HHLA2

A Phase 1a/1b Dose Escalation and Dose Expansion Study of NPX887 in Participants With Solid Tumor Malignancies Known to Express B7-H7/HHLA2

This study is testing a new treatment called NPX887 for people with solid tumors that have a specific marker to see if it helps shrink the tumors and how much of the drug is safe to use.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NextPoint Therapeutics, Inc. (industry)
• Drugs / interventions: immunotherapy, prednisone
• Locations: 8 sites (Baltimore, Maryland and 7 other locations)
• Trial ID: NCT06240728 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates NPX887, a monoclonal antibody targeting B7-H7 (HHLA2), in patients with solid tumors that express this biomarker. The study is designed in two phases: Phase 1a focuses on dose escalation to determine the optimal dosage, while Phase 1b assesses the preliminary efficacy of the selected doses across various tumor types. Participants will receive intravenous infusions of NPX887 and will be closely monitored for safety and anti-tumor activity. Blood and tumor tissue samples will be collected for further analysis of the drug's behavior and effectiveness.

Who should consider this trial

Good fit: Ideal candidates include individuals with recurrent, metastatic solid tumors that are refractory to or intolerant of standard therapies and express B7-H7/HHLA2.

Not a fit: Patients with solid tumors that do not express B7-H7/HHLA2 or those who have not progressed on standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that express B7-H7/HHLA2.

How similar studies have performed: While this approach is novel in targeting B7-H7/HHLA2, similar immunotherapy strategies have shown promise in other malignancies.

Eligibility criteria

Inclusion Criteria:

* Histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to, or intolerant of, standard of care therapy in one of the following indications:

  * Phase 1a (Dose Escalation): Non-small cell lung carcinoma (NSCLC), small cell lung carcinoma (SCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), gastric and gastro-esophageal carcinoma, esophageal adenocarcinoma, biliary tract cancers, ovarian carcinoma, and other solid tumor types known to express B7-H7/HHLA2.
  * Phase 1b including Part 1b (Dose Expansion) and Part 1c (Randomized Dose Comparison): participants who have clear cell RCC, EGFR mutant lung adenocarcinoma, or gastric/GEJ adenocarcinoma.
  * In Phase 1b, participants must have confirmed B7-H7/HHLA2 expression in their tumor 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 additional disease-specific enrollment criteria applied to clear cell RCC, EGFR mutant lung adenocarcinoma, 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 consent document
* Willing to use highly effective contraceptive measures throughout the trial.

Exclusion Criteria:

* Treatment with any of the following:

  * Systemic anticancer treatment ≤14 days or within 5 half-lives prior to the first dose of study drug, whichever is shorter.
  * Limited-field radiotherapy ≤7 days or extended-field thoracic radiotherapy ≤8 weeks of the first dose of study drug.
* Have any unresolved toxicity of ≥Grade 2 from previous anti-cancer treatment, except for 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 clinically stable, with no new or enlarging brain metastases as evidenced on MRI during screening.
* 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 endocrine abnormalities requiring replacement therapy or vitiligo.
* Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily.

Where this trial is running

Baltimore, Maryland and 7 other locations

• Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (ACTIVE_NOT_RECRUITING)
• Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts, United States (ACTIVE_NOT_RECRUITING)
• Albert Einstein Medical College Montefiore Medical Center — The Bronx, New York, United States (ACTIVE_NOT_RECRUITING)
• MD Anderson Cancer Center — Houston, Texas, United States (ACTIVE_NOT_RECRUITING)
• Next Oncology — San Antonio, Texas, United States (ACTIVE_NOT_RECRUITING)
• NEXT Oncology-Fairfax — Fairfax, Virginia, United States (ACTIVE_NOT_RECRUITING)
• Severance Hospital, Yonsei University Health System — Seoul, South Korea (RECRUITING)
• Samsung Medical Center — Seoul, South Korea (RECRUITING)

Study contacts

• Study coordinator: Trials nextpointtx

Conditions: Metastatic Malignant Neoplasm, B7-H7, HHLA2, solid tumor malignancies, monoclonal antibody, Dose escalation, Dose expansion, RECIST