Health Trials

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

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsor1ST Biotherapeutics, Inc.

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Phase Ia dose-escalation part of FB849 Monotherapy
  • Phase Ib dose-expansion of FB849 monotherapy
  • Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab
  • Phase 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)

Treatment groups

151 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

1ST Biotherapeutics, Inc.

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov