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

Launched by NEXTPOINT THERAPEUTICS, INC. · Jan 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NPX887 for patients with certain types of solid tumors that express a protein known as B7-H7 (or HHLA2). The main goal of the study is to find out if NPX887 is safe, how much of it can be given to patients, and whether it shows any signs of being effective in fighting cancer. This is the first study of NPX887 in humans, and it will involve giving the treatment through an intravenous (IV) infusion to participants whose cancer has not worsened. Throughout the trial, doctors will closely monitor the patients for any side effects and how well the treatment is working.

To be eligible for the trial, patients must have a specific type of advanced cancer that has not responded to standard treatments. They should also have a confirmed presence of the B7-H7 protein in their tumor, which will be tested beforehand. Patients aged 65 and older can participate, and the study is open to all genders. Participants will need to provide tumor tissue samples during the study and will be asked to follow certain guidelines regarding other treatments and health conditions. It's important that interested patients are willing to sign an informed consent form, showing that they understand the study and agree to take part.

Gender

ALL

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.