Phase Ia dose-escalation part of FB849 MonotherapyPhase Ib dose-expansion of FB849 monotherapyPhase IIb dose-escalation part of FB849 in Combination with PembrolizumabPhase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer)Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer)Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer)
Phase Ia dose-escalation part of FB849 Monotherapy: At a given level dose once daily
Phase Ib dose-expansion of FB849 monotherapy: At recommended dose for expansion cohort once daily
Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab: At recommended dose for expansion cohort once daily in combination with pembrolizumab
Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer): At recommended dose for expansion cohort once daily in combination with pembrolizumab
Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer): At recommended dose for expansion cohort once daily in combination with pembrolizumab
Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer): At recommended dose for expansion cohort once daily in combination with pembrolizumab
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
To assess the safety and tolerability of FB849 and to identify maximum tolerated dose (MTD)/ recommended Phase II dose (RP2D) and dosing schedule of FB849 in subjects with advanced solid tumors — DLT Assessment at the end of Cycle 1(each cycle is 21 days.) The MTD is defined to be the highest safe dose with an estimated DLT rate less than 30.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.