RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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

Quick Facts

Study Start:2023-10-09

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05761223

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

1STBIO Information center

CONTACT

+82-31-895-4677

info@1stbio.com

Principal Investigator

1STBIO Chief Development Officer

STUDY_DIRECTOR

1ST Biotherapeutics

Study Locations (Sites)

Mary Crowley Cancer Research Center

Dallas, Texas, 40118

United States

NEXT Oncology San Antonio

San Antonio, Texas, 78229

United States

Next Oncology Virginia

Fairfax, Virginia, 22031

United States

Summit Cancer Centers - Spokane Valley

Spokane, Washington, 99208

United States

Collaborators and Investigators

Sponsor: 1ST Biotherapeutics, Inc.

1STBIO Chief Development Officer, STUDY_DIRECTOR, 1ST Biotherapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-09

Study Completion Date2026-10

Study Record Updates

Study Start Date2023-10-09

Study Completion Date2026-10

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor