Evaluating BPT567 for patients with advanced solid tumors
A Phase 1 Investigation of the Safety, Tolerability and Preliminary Antitumor Activity of BPT567, a Multifunctional PD1-IL18 Immunocytokine in Patients With Advanced Solid Tumors
This study is testing a new treatment called BPT567 to see if it's safe and how well it works for people with advanced solid tumors who haven't responded to other therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bright Peak Therapeutics Inc Industry-sponsored |
| Drugs / interventions | radiation, prednisone |
| Locations | 3 sites (Scottsdale, Arizona and 2 other locations) |
| Trial ID | NCT06779851 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial is designed to assess the safety and tolerability of BPT567 in patients with advanced solid tumors. It involves a multicenter, open-label approach with dose escalation and expansion to determine the maximum tolerated dose and pharmacokinetics of the treatment. Eligible participants will have measurable disease and must have previously progressed on standard therapies. The study aims to establish a recommended dose for future cohorts.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced solid tumors that are locally advanced or metastatic and have progressed after standard treatments.
Not a fit: Patients who have recently received systemic therapy or investigational agents 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 who have limited treatment alternatives.
How similar studies have performed: Other studies evaluating similar investigational therapies have shown promise, but this specific approach with BPT567 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female aged ≥18 years at the time of signing informed consent form * Measurable disease per RECIST 1.1 * Histologically- or cytologically-diagnosed, locally advanced unresectable or metastatic solid tumor. Progressed or recurred after previously having received approved standard of care agents that are approved and available in their local geography. * ECOG Performance status of 0 or 1 * Life expectancy of at least 3 months * Adequate organ and marrow function * Contraception during study participation, as applicable Exclusion Criteria: * Has received systemic small molecule therapy or radiation therapy within 28 days prior to the first dose. * Treatment with biologic agents including anti-PD-1 or PD-L1 antibodies for less than 6 weeks or 5 half-lives, whichever is shorter, prior to first dose. * Received any investigational agent less than 28 days or 5 half-lives, whichever is shorter, prior to the first dose. * Treatment with another IL-18 therapy. * Received systemic immunosuppressive agents greater than the equivalent of prednisone 10mg daily within 14 days of the study, though inhaled, intranasal, topical or intra-articular corticosteroids are allowed. * Certain clinically significant intercurrent disease. * Primary immune deficiency. * Active untreated brain or spine metastasis or leptomeningeal metastases. * Known HIV seroposivitiy, although patients treated for HIV with no detectable viral load for at least 1 month while on a stable regimen of agents are permitted. * Active hepatitis A or acute or chroming hepatitis B or C infection. * Received a live virus vaccine within 30 days of enrollment or a COVD vaccine within 14 days.
Where this trial is running
Scottsdale, Arizona and 2 other locations
- Honor Health Research Institute — Scottsdale, Arizona, United States (Recruiting)
- Start Midwest — Grand Rapids, Michigan, United States (Recruiting)
- Carolina BioOncology Institute — Huntersville, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Sujatha Venugopal Prasad, M. Sc.
- Email: sprasad@brightpeaktx.com
- Phone: +1(408)357- 4546
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.