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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
1ST Biotherapeutics, Inc.
Study ID
NCT05761223
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Phase Ia dose-escalation part of FB849 Monotherapy — DRUG
    At a given level dose once daily
  • Phase Ib dose-expansion of FB849 monotherapy — DRUG
    At recommended dose for expansion cohort once daily
  • Phase IIb dose-escalation part of FB849 in Combination with Pembrolizumab — DRUG
    At recommended dose for expansion cohort once daily in combination with pembrolizumab
  • Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer) — DRUG
    At recommended dose for expansion cohort once daily in combination with pembrolizumab
  • Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer) — DRUG
    At recommended dose for expansion cohort once daily in combination with pembrolizumab
  • Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer) — DRUG
    At recommended dose for expansion cohort once daily in combination with pembrolizumab

Study Details

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.

Key Dates

Start date
Dec 13, 2023
Status verified
Aug 2025
Primary completion
Jun 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
151 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase Ia dose-escalation part of FB849 Monotherapy
    Participations will receive FB849 orally once a day.
  • Experimental: Phase Ib dose-expansion of FB849 monotherapy
    Participations will receive FB849 orally once a day.
  • Experimental: Phase IIa dose-escalation part of FB849 in Combination with Pembrolizumab
    Participations will receive FB849 orally once a day in combination with pembrolizumab.
  • Experimental: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer)
    Participations will receive FB849 orally once a day in combination with pembrolizumab.
  • Experimental: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer)
    Participations will receive FB849 orally once a day in combination with pembrolizumab.
  • Experimental: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer)
    Participations will receive FB849 orally once a day in combination with pembrolizumab.

Primary Outcome Measure

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 [ Time Frame: DLT Assessment at the end of Cycle 1(each cycle is 21 days.) ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Wen Wee Ma
Mary Crowley Cancer Research CenterDallasTexas40118
Douglas Orr
NEXT Oncology San AntonioSan AntonioTexas78229
Ildefonso Rodriguez Rivera
Next Oncology VirginiaFairfaxVirginia22031
Mohamad Adham Salkeni
Summit Cancer Centers - Spokane ValleySpokaneWashington99208
Arvind Chaudhry

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Cleveland Clinic· Cleveland, OHMary Crowley Cancer Research Center· Dallas, TXNEXT Oncology San Antonio· San Antonio, TXNext Oncology Virginia· Fairfax, VASummit Cancer Centers - Spokane Valley· Spokane, WA

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