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Anti-cancer agent

ABM-1310 + Cobimetinib for Cancer

Phase 1
Waitlist Available
Led By Sarina A Piha-Paul, M.D.
Research Sponsored by ABM Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
C-2: Patients with melanoma with brain metastasis and documentation of positive BRAF V600 mutation
Must have at least one measurable lesion as defined by RECIST V1.1 criteria for solid tumors or the RANO criteria for primary CNS tumors, such as gliomas.
Must not have
Patients with carcinomatous meningitis (leptomeningeal disease (LMD))
Known history of active infection with Hepatitis B (e.g., HBsAg reactive), or Hepatitis C (e.g., HCV RNA (qualitative) is detected)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to study discontinuation (an average of 1 year)
Awards & highlights

Summary

This trial is testing a new drug, ABM-1310, to see if it is safe and effective in treating cancer. The trial will have two parts, testing the drug alone and in combination with another drug, cobimetinib. The trial will use a "3+3" design to determine the maximum tolerated dose and the recommended Phase 2 dose.

Who is the study for?
Adults over 18 with advanced solid tumors and a BRAF V600 mutation, who've tried other treatments without success or can't use standard options. They must have good organ function, agree to contraception, and not be pregnant. Those with brain metastases are eligible if they're stable or on low-dose steroids.Check my eligibility
What is being tested?
ABM-1310 is being tested alone in patients with the BRAF V600E mutation or alongside Cobimetinib for those with any BRAF mutation and progressive disease after prior therapy. This Phase I trial aims to determine safety, tolerability, dosage levels, and initial effectiveness against cancer.See study design
What are the potential side effects?
Potential side effects include typical reactions related to cancer therapies such as fatigue, digestive issues like nausea or diarrhea, skin reactions from rash to itching, liver enzyme changes indicating potential liver damage, blood count variations which could lead to infections or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My melanoma has spread to my brain and tests positive for the BRAF V600 mutation.
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I have at least one tumor that can be measured by standard criteria.
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My brain tumor is smaller than 3 cm.
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My melanoma has spread to my brain and tests positive for the BRAF mutation.
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My advanced cancer has a positive BRAF mutation.
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I am fully active or able to carry out light work.
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My advanced cancer has a BRAF V600 mutation.
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My kidney function, measured by creatinine levels, is within normal limits.
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My CNS tumor has a positive BRAF V600 mutation.
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My advanced cancer has a BRAF mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cancer that has spread to the lining of my brain and spinal cord.
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I have an active Hepatitis B or C infection.
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I have a blood cancer, such as leukemia, lymphoma, or multiple myeloma.
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I do not have any severe illnesses or conditions that are not under control.
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I am currently on blood thinners like warfarin.
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I have not had a heart attack in the last 6 months.
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I do not have significant heart problems.
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I am a woman who can have children and do not use birth control.
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My heart's pumping ability is below 45%.
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I am on medication that affects my heart's rhythm and cannot change it.
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I have a genetic heart condition known as long QT syndrome.
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I have ongoing diarrhea that is moderate to severe.
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I haven't had extensive radiation or a bone marrow transplant in the last 5 years.
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I stopped my small molecule inhibitor treatment at least 2 weeks ago or 5 half-lives ago, whichever is longer.
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I am not pregnant or breast-feeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to study discontinuation (an average of 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to study discontinuation (an average of 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Area under the concentration time curve (AUC)
Disease Control Rate (DCR)
Duration of Response (DOR)
+10 more
Other outcome measures
Exploratory preliminary efficacy in patients by types of BRAF V600 mutation
Identification of major metabolite of ABM-1310 in patients who receive ABM-1310 monotherapy in Part C

Trial Design

6Treatment groups
Experimental Treatment
Group I: Monotherapy Therapy Dose Expansion-2Experimental Treatment1 Intervention
- In C-2 (Monotherapy - Advanced or Metastatic Solid Tumors excluding Primary CNS Tumor with or without Brain Metastasis), continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose (RP2D) from Part A until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met.
Group II: Monotherapy Therapy Dose Expansion-1Experimental Treatment1 Intervention
- In C-1(Monotherapy - Primary CNS Tumors), continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose (RP2D) from Part A until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met.
Group III: Monotherapy Dose EscalationExperimental Treatment1 Intervention
A classic "3+3" design will be used to determine MTD and RP2D. Three to six patients per treatment cohort will be assigned to receive sequentially higher oral doses of ABM-1310 on a twice daily schedule (bid) for 28-day cycles, starting at a dose of 25 mg bid. Patients will receive twice daily oral doses of ABM-1310 continuously until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met.
Group IV: Combination Therapy Dose Expansion-2Experimental Treatment2 Interventions
- In C-4 (Combination therapy - Melanoma with Brain Metastasis), continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose (RP2D) from Part B, in combination with cobimetinib (Cotellic®) 60 mg administered the first 21 days of each 28-day treatment cycle until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met.
Group V: Combination Therapy Dose Expansion-1Experimental Treatment2 Interventions
- In C-3 (Combination therapy - Advanced/Metastatic Solid Tumors including Primary CNS tumors but excluding Melanoma with Brain metastasis), continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose (RP2D) from Part B, in combination with cobimetinib (Cotellic®) 60 mg administered the first 21 days of each 28-day treatment cycle until disease progression, unacceptable toxicity, or a clinical observation satisfying another withdrawal criterion is met.
Group VI: Combination Therapy Dose EscalationExperimental Treatment2 Interventions
A classic "3+3" design will guide the dose escalation in Part B. At each dose level, ABM-1310 will be administered in combination with cobimetinib (Cotellic ®) once daily (qd) for the first 21 days of each 28-day treatment cycle. The starting dose of ABM-1310 will be a dose below the MTD that has been demonstrated to be safe in Part A Monotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cobimetinib
2017
Completed Phase 3
~3070

Find a Location

Who is running the clinical trial?

ABM Therapeutics, Inc.Lead Sponsor
ABM Therapeutics CorporationLead Sponsor
1 Previous Clinical Trials
112 Total Patients Enrolled
Sarina A Piha-Paul, M.D.Principal InvestigatorM.D. Anderson Cancer Center

Media Library

ABM-1310 (Anti-cancer agent) Clinical Trial Eligibility Overview. Trial Name: NCT04190628 — Phase 1
BRAF Mutation Research Study Groups: Combination Therapy Dose Expansion-2, Combination Therapy Dose Escalation, Monotherapy Dose Escalation, Monotherapy Therapy Dose Expansion-1, Monotherapy Therapy Dose Expansion-2, Combination Therapy Dose Expansion-1
BRAF Mutation Clinical Trial 2023: ABM-1310 Highlights & Side Effects. Trial Name: NCT04190628 — Phase 1
ABM-1310 (Anti-cancer agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04190628 — Phase 1
~10 spots leftby Jul 2025