Investigating the safety and efficacy of FB849 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, multicenter, open-label Phase I/II study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of FB849, both alone and in combination with pembrolizumab, in patients with advanced solid tumors who lack standard treatment options. The study consists of four parts, including a dose-escalation phase to determine the maximum tolerated dose and a dose-expansion phase to assess safety and anti-tumor activity. An adaptive Bayesian optimal interval design will be utilized to allow for flexible dose adjustments based on patient responses. The study aims to provide critical insights into the therapeutic potential of FB849 in this challenging patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: 1STBIO Information center
• Email: info@1stbio.com
• Phone: +82-31-895-4677

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.