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

1ST Biotherapeutics, Inc.

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.

Description

The study will be conducted in 3 parts: Phase I dose-escalation part with FB849 monotherapy and Phase II dose-escalation and dose-expansion parts of FB849 in combination with pembrolizumab. The Phase Ia dose-escalation part will use an adaptive study design termed Bayesian optimal interval (BOIN) design to investigate the safety and tolerability of FB849, and determine the maximum tolerated dose (MTD) and preliminary recommended Phase II dose (RP2D) of FB849. A BOIN design is a hybrid of rule-based and model-based design, which has the flexibility of dose escalation and de-escalation and allo…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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 a…

Interventions

Drug
Phase Ia dose-escalation part of FB849 Monotherapy
At a given level dose once daily
Drug
Phase Ib dose-expansion of FB849 monotherapy
At recommended dose for expansion cohort once daily
Drug
Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab
At recommended dose for expansion cohort once daily in combination with pembrolizumab
Drug
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
Drug
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

Locations (5)

Cleveland Clinic
Cleveland, Ohio
Mary Crowley Cancer Research Center
Dallas, Texas
NEXT Oncology San Antonio
San Antonio, Texas
Next Oncology Virginia
Fairfax, Virginia
Summit Cancer Centers - Spokane Valley
Spokane, Washington