What side effects are associated with this type of intervention?

Common treatments for tumors, including chemotherapy, targeted therapy, and immunotherapy, often result in a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections due to bone marrow suppression. Targeted therapies, which interfere with specific molecules involved in tumor growth, may lead to skin rashes, diarrhea, and liver function abnormalities. Immunotherapy, which boosts the body's immune response against cancer cells, can cause immune-related adverse effects such as colitis, pneumonitis, and thyroid dysfunction. These side effects vary in severity and frequency depending on the specific drugs and patient factors.

What prior FDA approvals exist?

The FDA has approved several treatments for tumors, including targeted therapies and immunotherapies. For example, Cabozantinib (XL184) is an oral tyrosine kinase inhibitor approved for medullary thyroid cancer, which targets multiple kinases involved in tumor growth and angiogenesis. Pembrolizumab and Nivolumab are immune checkpoint inhibitors approved for various cancers, including melanoma and lung cancer, which work by enhancing the body's immune response against tumor cells. Additionally, ONC201, an investigational oral compound, is being studied for H3 K27M-mutant gliomas, showing promising results in early trials. These treatments represent a range of mechanisms, from kinase inhibition to immune modulation, reflecting the diverse strategies in cancer therapy.

What other types of research exist?

Promising alternatives to FORE8394 for tumor patients include Bevacizumab, which has shown efficacy in reducing vestibular schwannomas in NF2-related cases, and ONC201, a selective DRD2 antagonist, which has demonstrated potential in treating H3 K27M-mutant diffuse midline gliomas. Additionally, Cabozantinib, an oral tyrosine kinase inhibitor, has shown activity in medullary thyroid cancer, and Infigratinib, an FGFR-selective tyrosine kinase inhibitor, has been effective in cholangiocarcinoma with FGFR2 fusions/rearrangements.

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FORE8394 for Advanced Unresectable Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Fore Biotherapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with advanced unresectable gliomas driven by an activating BRAF V600 or activating non-V600 mutation and no prior exposure to a BRAF, MEK, or ERK inhibitor

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

Must not have

Clinically significant cardiac disease

Participants with known co-occurring RAS-related mutations or RTK activation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Summary

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

Who is the study for?

This trial is for people aged 10 and above, weighing at least 30 kg, with advanced solid tumors that have specific BRAF mutations. It's not open to those who've had prior treatment with BRAF, MEK, or ERK inhibitors or have standard therapy options available.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of a new drug called FORE8394 on patients with certain types of advanced solid tumors. They're looking for the highest dose patients can take without serious side effects and how well it works.See study design

What are the potential side effects?

While the exact side effects are being studied, similar cancer drugs often cause fatigue, nausea, skin reactions, liver issues, and increased risk of infections. The severity can range from mild to severe.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My glioma has a specific BRAF mutation and I haven't been treated with BRAF, MEK, or ERK inhibitors.

Select...

My advanced cancer has not responded to, came back after, or I couldn't tolerate standard treatments, or there are no standard treatments available.

Select...

My solid tumor is caused by a specific BRAF mutation and I haven't had BRAF therapy.

Select...

My advanced cancer is caused by a specific BRAF mutation and I haven't been treated with BRAF, MEK, or ERK inhibitors.

Select...

I am 10 years or older and weigh at least 30 kg.

Select...

My brain tumor is classified as high grade (Grade 3 or 4) or low grade.

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I am fully active or can carry out light work.

Select...

My solid tumor is caused by a specific BRAF mutation and I haven't had BRAF-targeted treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a serious heart condition.

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My cancer has RAS mutations or RTK activation.

Select...

I haven't had major surgery or significant injury within the last 14 days.

Select...

I do not have any unmanaged ongoing illnesses.

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I have colorectal or pancreatic cancer.

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I have severe nausea, vomiting, or issues absorbing food due to my condition.

Select...

I am not infected with HIV, HBV, or HCV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Area under the curve (AUC) of FORE8394

Compare AUC of FORE8394 with FORE8394

Compare Cmax of FORE8394 with FORE8394

+8 more

Secondary outcome measures

Clinical benefit rate (defined as stable disease, partial response and complete response) after 24 weeks on study

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: FORE8394Experimental Treatment1 Intervention

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

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for tumors include chemotherapy, targeted therapy, immunotherapy, and radiation therapy. Chemotherapy kills rapidly dividing cells, while targeted therapy blocks specific molecules involved in tumor growth. Immunotherapy enhances the immune system to recognize and destroy cancer cells, and radiation therapy damages the DNA of cancer cells, leading to cell death. Understanding these mechanisms helps patients grasp how treatments work, potential side effects, and the rationale behind choosing a specific therapy.

Current trends and future directions in the genetic therapy of human neoplastic disease.