NPX887 treatment for solid tumors expressing B7-H7/HHLA2

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Severance Hospital, Yonsei University Health System
  Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting
• 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

Study contacts

• Study coordinator: Trials nextpointtx
• Email: trials@nextpointtx.com
• Phone: (888) 929-NEXT

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.