NCT05320588 A Study in Patients With Advanced Cancers
| NCT ID | NCT05320588 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | BiOneCure Therapeutics Inc. |
| Condition | Advanced Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 332 participants |
| Start Date | 2022-03-25 |
| Primary Completion | 2024-04 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 332 participants in total. It began in 2022-03-25 with a primary completion date of 2024-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers.
Eligibility Criteria
Key Inclusion Criteria: * Patients histologically or cytologically documented, locally advanced or metastatic solid tumor. * Disease progression confirmed by imaging or other objective evidence after having received standard treatment; or patients with refractory solid tumors who cannot tolerate standard treatment or have contraindications to standard treatment. * Measurable disease as determined by RECIST v.1.1 or bone only disease. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Key Exclusion Criteria: * History of severe hypersensitivity to any ingredient of the study drug(s), including pembrolizumab or other monoclonal antibody. Impaired cardiac function or history of clinically significant cardiac disease * Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection. * Active SARS-CoV-2 infection. * Untreated central nervous system (CNS), epidural tumor or metastasis, or brain metastasis. Other protocol defined inclusion/exclusion criteria may apply.
Contact & Investigator
BiOneCure Clinical Development
STUDY DIRECTOR
BiOneCure Therapeutics Inc.
Frequently Asked Questions
Who can join the NCT05320588 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05320588 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05320588 currently recruiting?
Yes, NCT05320588 is actively recruiting participants. Contact the research team at Starbridge-1@bionecure.com for enrollment information.
Where is the NCT05320588 trial being conducted?
This trial is being conducted at Austin, United States, Houston, United States, Fairfax, United States.
Who is sponsoring the NCT05320588 clinical trial?
NCT05320588 is sponsored by BiOneCure Therapeutics Inc.. The principal investigator is BiOneCure Clinical Development at BiOneCure Therapeutics Inc.. The trial plans to enroll 332 participants.
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