A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, PK, and Preliminary Efficacy of FB849

• Status: Not yet recruiting
• Trial end date: 2026-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 1ST Biotherapeutics, Inc.
• Treatments: Pembrolizumab

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.