NCT05761223 A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849
| NCT ID | NCT05761223 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | 1ST Biotherapeutics, Inc. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 151 participants |
| Start Date | 2023-12-13 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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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 151 participants in total. It began in 2023-12-13 with a primary completion date of 2026-06.
⚠ 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
This is the first-in-human, multicenter, open-label Phase I/II study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of FB849 alone and in combination with pembrolizumab in subjects with advanced solid tumors for whom no standard therapy is available.
Eligibility Criteria
Inclusion Criteria: * Subject should understand, sign, and date the written ICF prior to screening. * Male or female aged 18 years or older. * Subjects must have at least 1 measurable target lesion according to RECIST version 1.1. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Life expectancy ≥ 3 months in the opinion of the investigator. * Adequate organ function and bone marrow function as indicated by the following screening assessments performed within 14 days prior to the first dose of study treatment Exclusion Criteria: * Known allergy or hypersensitivity to any component of the study treatment. * Has a known additional malignancy that is progressing or has required active treatment. * Has abnormal or inadequately controlled endocrine function. * Inability to take oral medication or significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption of oral medication. * Previous anti-cancer therapy, including chemotherapy (chemotherapy with nitrosourea or mitomycin should be at least 6 weeks prior to initiation of study treatment), radiotherapy, molecular targeted therapy, or other investigational drugs received ≤ 4 weeks; endocrine therapy ≤ 2 weeks or ≤ 5-half-lives (whichever is shorter) prior to initiation of study treatment.
Contact & Investigator
1STBIO Chief Development Officer
STUDY DIRECTOR
1ST Biotherapeutics
Frequently Asked Questions
Who can join the NCT05761223 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. 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 NCT05761223 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 NCT05761223 currently recruiting?
Yes, NCT05761223 is actively recruiting participants. Contact the research team at info@1stbio.com for enrollment information.
Where is the NCT05761223 trial being conducted?
This trial is being conducted at Cleveland, United States, Dallas, United States, San Antonio, United States, Fairfax, United States and 1 additional location.
Who is sponsoring the NCT05761223 clinical trial?
NCT05761223 is sponsored by 1ST Biotherapeutics, Inc.. The principal investigator is 1STBIO Chief Development Officer at 1ST Biotherapeutics. The trial plans to enroll 151 participants.