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

ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsor1ST Biotherapeutics, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

151 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Phase Ia dose-escalation part of FB849 MonotherapyExperimental treatment 1 intervention
Group B: Phase Ib dose-expansion of FB849 monotherapyExperimental treatment 1 intervention
Group C: Phase IIa dose-escalation part of FB849 in Combination with PembrolizumabExperimental treatment 1 intervention
Group D: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type A cancer)Experimental treatment 1 intervention
Group E: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type B cancer)Experimental treatment 1 intervention
Group F: Phase IIb dose-expansion part of FB849 in Combination with Pembrolizumab (Type C cancer)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

The MTD is defined to be the highest safe dose with an estimated DLT rate less than 30.

Time frame
DLT Assessment at the end of Cycle 1(each cycle is 21 days.)

Secondary outcomes

1

To determine the pharmacokinetic parameters such as Peak Plasma Concentration (Cmax) of FB849

The PK parameters should include, where appropriate, area under the concentration-time curve (AUC), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), and apparent terminal elimination half-life (t1/2), apparent total body clearance (CL/F), apparent volume of distribution (Vz/F), Cmax at steady state (Css-max), minimum observed concentration at steady state (Css-min), AUC at steady state (AUCss), accumulation ratio (Rac), amount excretion (Ae), fraction excretion (Fe), renal clearance (CLR).

Time frame
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
2

To assess preliminary anti-tumor activity of FB849

Tumor response will be assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) of the chest, abdomen/pelvis, and additional assessments (e.g., craniocerebral imaging, bone scan) based on clinical indications.

Time frame
every 6 weeks (± 3 days) in the first 18 weeks, then every 12 weeks (± 7 days) thereafter until disease progression assessed up to approximately 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

1ST Biotherapeutics, Inc.

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator

Source ClinicalTrials.gov
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