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Outcome Measures

Primary Outcomes (11)

Area under the curve (AUC) of FORE8394
First dose of FORE8394 up to 30 days after end of treatment
Maximum concentration (Cmax) of FORE8394
First dose of FORE8394 up to 30 days after end of treatment
Time to peak concentration (Tmax) of FORE8394
First dose of FORE8394 up to 30 days after end of treatment
Half life (T1/2) of FORE8394
First dose of FORE8394 up to 30 days after end of treatment
Number of participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v4.0.
First dose of FORE8394 up to 30 days after end of treatment
To identify the recommended Phase 2 dose (RP2D) of FORE8394 in Group A (adult patients) for further evaluation in Dose Extension.
2 years

Secondary Outcomes (3)

To evaluate the duration of response (defined as time of initial response to progressive disease or death) at the applicable RP2D in Dose Extension.
5 years
To evaluate the progression free survival (defined as time of first dose to progressive disease or death) at the applicable RP2D in Dose Extension.
5 years
Clinical benefit rate (defined as stable disease, partial response and complete response) after 24 weeks on study
5 years

Study Arms (1)

FORE8394

EXPERIMENTAL

Group A: Phase 1-Dose Escalation: Adult patients. Group B: Phase 1-Dose Escalation: Pediatric patients. Phase 2a-Dose Extension: Adult patients with advanced unresectable solid tumors will be enrolled among two cohorts. * Cohort 1: Activating BRAF V600 mutations (glioma patients only) * Cohort 2: Activating BRAF non-V600 mutations Phase 2a-RP2D Confirmation: Adult patients. Phase 2a-RP2D Redefinition and Extension: * Cohort 3: Activating BRAF V600 or activating non-V600 mutation * Cohort 4: Activating BRAF non-V600 mutations Phase 2a-RP2D Redefinition: * Cohort 6A: Advanced activating BRAF-mutated solid tumors * Cohort 7A: Advanced activating BRAF-mutated solid tumors * Cohort 8A: Advanced activating BRAF-mutated solid tumors

Drug: FORE8394

Eligibility Criteria

Age10 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 10 years and at least 30 kg.
Phase 1-Dose Escalation (no longer enrolling as of Protocol Amendment 10): 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.

Study Sites (13)

HonorHealth

Scottsdale, Arizona, 85258, United States

St. Joseph's Hospital at Orange

Orange, California, 92868, United States

Stanford Hospitals and Clinics

Stanford, California, 94305, United States

University of Miami

Miami, Florida, 33136, United States

Community Health Network

Indianapolis, Indiana, 46011, United States

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

A Study of FORE8394 as a Single Agent in Patients With Advanced Unresectable Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (11)

Secondary Outcomes (3)

Study Arms (1)

FORE8394

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (11)

Secondary Outcomes (3)

Study Arms (1)

FORE8394

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations