FORE8394 for BRAF-mutated Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
BRAF-mutated Tumors+1 MoreFORE8394 - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Eligible Conditions
  • BRAF-mutated Tumors
  • Advanced Unresectable Solid Tumors

Treatment Effectiveness

Study Objectives

22 Primary · 3 Secondary · Reporting Duration: 5 years

2 years
To identify the recommended Phase 2 dose (RP2D) of FORE8394 in Group A (adult patients) for further evaluation in Dose Extension.
To identify the recommended Phase 2 dose (RP2D) of PLX8394 (Formulation 1) in Group A (adult patients) for further evaluation in Dose Extension.
5 years
Clinical benefit rate (defined as stable disease, partial response and complete response) after 24 weeks on study
To determine the overall response rate of FORE8394 treatment at the applicable RP2D in a) Group A, Cohort 1, and b) Group A, Cohort 2.
To determine the overall response rate of PLX8394 treatment at the applicable RP2D in a) Group A, Cohort 1, and b) Group A, Cohort 2.
To evaluate the duration of response (defined as time of initial response to progressive disease or death) at the applicable RP2D in Dose Extension.
To evaluate the progression free survival (defined as time of first dose to progressive disease or death) at the applicable RP2D in Dose Extension.
Day 30
Area under the curve (AUC) of FORE8394
Compare AUC of FORE8394 with FORE8394
Compare Cmax of FORE8394 with FORE8394
Compare T1/2 of FORE8394 with FORE8394
Compare Tmax of FORE8394 with FORE8394
Half life (T1/2) of FORE8394
Maximum concentration (Cmax) of FORE8394
Number of participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v4.0.
Time to peak concentration (Tmax) of FORE8394
Day 30
Area under the curve (AUC) of PLX8394 (Formulation 1 and Formulation 2)
Compare AUC of PLX8394 (Formulation 1) with PLX8394 (Formulation 2)
Compare Cmax of PLX8394 (Formulation 1) with PLX8394 (Formulation 2)
Compare T1/2 of PLX8394 (Formulation 1) with PLX8394 (Formulation 2)
Compare Tmax of PLX8394 (Formulation 1) with PLX8394 (Formulation 2)
Half life (T1/2) of PLX8394 (Formulation 1 and Formulation 2)
Maximum concentration (Cmax) of PLX8394 (Formulation 1 and Formulation 2)
Number of participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v4.0 (Formulation 1 and Formulation 2).
Time to peak concentration (Tmax) of PLX8394 (Formulation 1 and Formulation 2)

Trial Safety

Trial Design

2 Treatment Groups

PLX8394
1 of 2
FORE8394
1 of 2

Experimental Treatment

100 Total Participants · 2 Treatment Groups

Primary Treatment: FORE8394 · No Placebo Group · Phase 1 & 2

PLX8394
Drug
Experimental Group · 1 Intervention: PLX8394 · Intervention Types: Drug
FORE8394
Drug
Experimental Group · 1 Intervention: FORE8394 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Fore BiotherapeuticsLead Sponsor
5 Previous Clinical Trials
225 Total Patients Enrolled
Stacie Peacock Shepherd, MD, PhDStudy ChairFore Biotherapeutics U.S. Inc.

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a child or young adult with at least 30 kg of body weight.
Patients with histologically confirmed advanced solid tumors who are refractory to, relapsed after, or intolerant to standard therapy or for whom no standard therapy exists.
You have a solid tumor with an activating BRAF-V600 mutation.
You have a solid tumor driven by an activating BRAF mutation.
Participants with no prior exposure to BRAF-directed therapy and for whom no standard therapy exists.
You have received a Phase 2a dose of ondansetron and are now in Cohort 2.