Clinical Trial 23055

• Overview

  Study Title:

  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

  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.

  Objective:

  Phase Ia Part (Dose Escalation of FB849 Monotherapy): Primary Objective: *To assess the safety and tolerability of FB849 and to identify maximum tolerated dose (MTD)/ preliminary recommended Phase II dose (RP2D) and dosing schedule of FB849 in subjects with selected, advanced solid tumors Secondary Objectives: *To determine the pharmacokinetic (PK) profile of FB849 *To assess preliminary anti-tumor activity of FB849 Exploratory Objectives: *To investigate the pharmacodynamics of FB849 *To investigate the metabolites of FB849 Phase IIa Part (Dose Escalation of FB849 in Combination with Pembrolizumab): Primary Objectives: *To assess the safety and tolerability of FB849 at the recommended Phase II dose (RP2D) and at > 1 dose lower than the RP2D in combination with the approved dose and regimen of pembrolizumab *To identify RP2D of FB849 in combination with pembrolizumab Secondary Objectives: *To determine the pharmacokinetic (PK) profile of FB849 in combination with pembrolizumab *To assess preliminary anti-tumor activity of FB849 in combination with pembrolizumab Exploratory Objectives: *To investigate the pharmacodynamics of FB849 in combination with pembrolizumab *To investigate the metabolites of FB849 in combination with pembrolizumab Phase IIb Part (Dose Expansion of FB849 in Combination with Pembrolizumab): Primary Objectives: *To further assess the safety and tolerability of FB849 at the recommended Phase II dose (RP2D) in combination with pembrolizumab *To assess preliminary anti-tumor activity of FB849 in combination with pembrolizumab Secondary Objectives: *To determine the pharmacokinetic (PK) profile of FB849 in combination with pembrolizumab *To assess preliminary anti-tumor activity of FB849 in combination with pembrolizumab Exploratory Objectives: *To investigate the pharmacodynamics of FB849 in combination with pembrolizumab *To investigate the metabolites of FB849 in combination with pembrolizumab

• Treatments

  Therapies:

  HPK1 Kinase Inhibitor; Immunotherapy

  Medications:

  FB849 (); Pembrolizumab (Keytruda)

• Inclusion Criteria

  Key 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

  Key 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.

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