A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FB849 Administered in Subjects with Advanced Solid Tumors Alone and in Combination with Pembrolizumab
A Phase I/II, Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FB849 Administered in Subjects with Advanced Solid Tumors Alone and in Combination with Pembrolizumab
Mechanism of Action
FB849 is a HPK1 inhibitor
Purpose
In this study, the sponsor and investigators want to learn:
- How much of the study drug can be given with an acceptable level of side effects
- The effects of the study drug (good and bad)
- How much of the study drug is absorbed into the blood and how fast it is removed
- How the study drug is acting on your body
- 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
- 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.
Phase I part: Subjects with histologically confirmed solid tumors who have progressed on or are intolerant of standard therapy or for whom no standard therapy exists.
Phase II part, Cohort 1 (FB849 monotherapy): Subjects with histologically confirmed solid tumors who have progressed on or are intolerant of standard therapy or for whom no standard therapy exists.
Phase II part, Cohort 2 (FB849 + pembrolizumab): Subjects with locally advanced/metastatic TNBC that progressed or are intolerant to standard of care first-line therapy (chemotherapy ± anti-programmed cell death protein 1 [PD-1] therapy).
Phase II part, Cohort 3 (FB849 + pembrolizumab): Subjects with locally advanced/metastatic MSI-high CRC that progressed or are intolerant to first-line chemotherapy + pembrolizumab.
Phase II part, Cohort 4 (FB849 + pembrolizumab): Subjects with locally advanced/metastatic MSI-low CRC that progressed or are intolerant to first-line chemotherapy.
NOTE: for Phase II cohorts, subjects may have received more than 1 line of systemic therapy but no more than 4 lines.
Location
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