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

Description

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.

Conditions

Advanced Solid Tumor

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Study Overview

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Study Details

Study overview

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.

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, PK, and Preliminary Efficacy of FB849

Condition
Advanced Solid Tumor
Intervention / Treatment

-

Contacts and Locations

Dallas

Mary Crowley Cancer Research Center, Dallas, Texas, United States, 40118

San Antonio

NEXT Oncology San Antonio, San Antonio, Texas, United States, 78229

Fairfax

Next Oncology Virginia, Fairfax, Virginia, United States, 22031

Spokane

Summit Cancer Centers - Spokane Valley, Spokane, Washington, United States, 99208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

1ST Biotherapeutics, Inc.,

1STBIO Chief Development Officer, STUDY_DIRECTOR, 1ST Biotherapeutics

Study Record Dates

2026-10