Testing NPX267 for patients with solid tumors expressing HHLA2/B7-H7
A Phase 1a/1b, Dose-Escalation/Dose-Expansion Study of NPX267 in Subjects With Solid Tumors Known to Express HHLA2/B7-H7
This study is testing a new drug called NPX267 to see if it can help people with certain types of solid tumors that express a specific protein, by boosting their immune response against the cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 131 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NextPoint Therapeutics, Inc. Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 7 sites (Baltimore, Maryland and 6 other locations) |
| Trial ID | NCT05958199 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates NPX267, an antibody drug designed to target the inhibitory receptor HHLA2/B7-H7, which may help overcome immune evasion in tumors. The study is divided into two parts: a dose escalation phase to determine the appropriate dosage and a dose expansion phase to assess the drug's effectiveness in patients with specific solid tumors. Participants will receive intravenous infusions of NPX267 every three weeks, and their response will be monitored through imaging and blood tests to evaluate the drug's pharmacokinetics and safety. The trial focuses on patients with various types of metastatic solid tumors that express HHLA2.
Who should consider this trial
Good fit: Ideal candidates include patients with recurrent, metastatic solid tumors that are refractory to standard therapies and express HHLA2.
Not a fit: Patients with unresolved toxicity from previous treatments or known brain metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with solid tumors that currently have limited treatment options.
How similar studies have performed: While this approach is novel, similar studies targeting immune evasion mechanisms have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to standard of care therapy in one of the following indications: Part 1a: non-small cell lung carcinoma (NSCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), cholangiocarcinoma (CCA), pancreatic cancer (PDAC), urothelial carcinoma (UCC), gastric/gastroesophageal carcinoma, triple negative breast carcinoma, endometrial carcinoma, cervical cancer, osteosarcoma, and prostate cancer * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Normal bone marrow, kidney and liver function * Willing to use highly effective contraceptive measures throughout the trial Exclusion Criteria: * Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia, chronic neuropathy \> 6 months, or changes in skin pigmentation * Have known or suspected brain metastases, unless they are clinically stable * Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily * History of grade 3 immune-related pneumonitis or colitis
Where this trial is running
Baltimore, Maryland and 6 other locations
- Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center — Baltimore, Maryland, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Albert Einstein Medical College Montefiore Medical Center — New York, New York, United States (Recruiting)
- Sarah Cannon Research Institute Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- NEXT Oncology-San Antonio — San Antonio, Texas, United States (Recruiting)
- NEXT Oncology-Fairfax — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Trials nextpointtx
- Email: trials@nextpointtx.com
- Phone: (508) 204-1115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.