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Phase Ia dose-escalation part of FB849 Monotherapy for Solid Tumors
Phase 1 & 2
Recruiting
Research Sponsored by 1ST Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood: predose, 1, 2, 4, 8, 12, 24 hours postdose at c1d1 and c1d21; predose and 4, 8, and 24 hours postdose at c1d8; predose at c1d15; and predose on c2d1, c4d1, and c6d1, urine: predose and 0-4 hour, 4-8 hour, 8-12 hour, 12-24 hour post-dose
Awards & highlights
Study Summary
This trial is the first of its kind and it will be conducted in multiple centers. It is an open-label study, which means that both the researchers and the participants will know which treatment is being given
Who is the study for?
This trial is for adults over 18 with advanced solid tumors and no standard therapy options left. They must be able to understand the study, sign consent, have a measurable tumor lesion, be relatively active (ECOG status 0 or 1), and expected to live at least another three months. Their organs and bone marrow must function well.Check my eligibility
What is being tested?
The trial is testing FB849 alone and in combination with pembrolizumab on different types of cancer (Type A, B, C). It's an early-stage study looking at how safe it is, what side effects occur, how the body processes it (PK), its impact on the body (pharmacodynamics), and if it works against cancer.See study design
What are the potential side effects?
Possible side effects include those common to cancer treatments such as fatigue, nausea, immune-related reactions due to pembrolizumab like skin rash or colitis. Since this is a first-in-human study for FB849 specifically, close monitoring will identify any unique side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ blood: predose, 1, 2, 4, 8, 12, 24 hours postdose at c1d1 and c1d21; predose and 4, 8, and 24 hours postdose at c1d8; predose at c1d15; and predose on c2d1, c4d1, and c6d1, urine: predose and 0-4 hour, 4-8 hour, 8-12 hour, 12-24 hour post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood: predose, 1, 2, 4, 8, 12, 24 hours postdose at c1d1 and c1d21; predose and 4, 8, and 24 hours postdose at c1d8; predose at c1d15; and predose on c2d1, c4d1, and c6d1, urine: predose and 0-4 hour, 4-8 hour, 8-12 hour, 12-24 hour post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the safety and tolerability of FB849 and to identify maximum tolerated dose (MTD)/ recommended Phase II dose (RP2D) and dosing schedule of FB849 in subjects with advanced solid tumors
Secondary outcome measures
To assess preliminary anti-tumor activity of FB849
To determine the pharmacokinetic parameters such as Peak Plasma Concentration (Cmax) of FB849
Trial Design
6Treatment groups
Experimental Treatment
Group I: Phase Ib dose-expansion of FB849 monotherapyExperimental Treatment1 Intervention
Participations will receive FB849 orally once a day.
Group II: Phase Ia dose-escalation part of FB849 MonotherapyExperimental Treatment1 Intervention
Participations will receive FB849 orally once a day.
Group III: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer)Experimental Treatment1 Intervention
Participations will receive FB849 orally once a day in combination with pembrolizumab.
Group IV: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer)Experimental Treatment1 Intervention
Participations will receive FB849 orally once a day in combination with pembrolizumab.
Group V: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer)Experimental Treatment1 Intervention
Participations will receive FB849 orally once a day in combination with pembrolizumab.
Group VI: Phase IIa dose-escalation part of FB849 in Combination with PembrolizumabExperimental Treatment1 Intervention
Participations will receive FB849 orally once a day in combination with pembrolizumab.
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Who is running the clinical trial?
1ST Biotherapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
88 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,995 Total Patients Enrolled
1STBIO Chief Development OfficerStudy Director1ST Biotherapeutics
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available vacancies for patient participation in this clinical trial?
"Indeed, the information on clinicaltrials.gov states that this study is presently enrolling patients. It was initially posted on October 9th, 2023 and has since been updated most recently on January 31st, 2024."
Answered by AI
What is the upper limit for patient participation in this particular research endeavor?
"Indeed, the information available on clinicaltrials.gov indicates that this study is actively seeking suitable candidates for participation. The trial was publicly posted on October 9th, 2023 and underwent its most recent revision on January 31st, 2024. A total of 121 participants will be enrolled in this clinical investigation at a single designated site."
Answered by AI
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