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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to study discontinuation (an average of 1 year)
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to study discontinuation (an average of 1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to study discontinuation (an average of 1 year)
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 moreOther 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
~2660
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My melanoma has spread to my brain and tests positive for the BRAF V600 mutation.I have at least one tumor that can be measured by standard criteria.I have cancer that has spread to the lining of my brain and spinal cord.I had major surgery less than 4 weeks ago but feel recovered.My brain tumor is smaller than 3 cm.I haven't had major radiation in the last month or recovered from its side effects.My melanoma has spread to my brain and tests positive for the BRAF mutation.I have an active Hepatitis B or C infection.I have a blood cancer, such as leukemia, lymphoma, or multiple myeloma.I have not had a stroke in the last 6 months.I have used steroids recently but only in low doses or for replacement.I do not have any severe illnesses or conditions that are not under control.I haven't had cancer treatment in the last 4 weeks or still have side effects.I am currently on blood thinners like warfarin.I agree to use effective birth control during and for 60 days after the study.My advanced cancer has a positive BRAF mutation.My cancer has worsened after treatment, or there's no standard treatment for it, or standard treatment isn't right for me.My organs are working well, as confirmed by recent tests.You have a history of alcohol or drug abuse within the past 3 months before starting the study.I have not had a heart attack in the last 6 months.I am 18 or older and can follow study rules.My brain cancer is under control, and I'm taking a low dose of steroids or none.I do not have GI conditions that could affect medicine absorption.I am fully active or able to carry out light work.I do not have significant heart problems.You have a pacemaker implanted in your body.I am a woman who can have children and do not use birth control.My advanced cancer has a BRAF V600 mutation.I have taken a pregnancy test in the last 72 hours and it was negative.My heart's pumping ability is below 45%.My kidney function, measured by creatinine levels, is within normal limits.My CNS tumor has a positive BRAF V600 mutation.My advanced cancer has a BRAF mutation.I haven't taken nitrosourea or mitomycin-C in the last 6 weeks.I am on medication that affects my heart's rhythm and cannot change it.I have brain lesions between 0.5 and 3 cm in size.I have a genetic heart condition known as long QT syndrome.I have ongoing diarrhea that is moderate to severe.I haven't had extensive radiation or a bone marrow transplant in the last 5 years.I stopped my small molecule inhibitor treatment at least 2 weeks ago or 5 half-lives ago, whichever is longer.I have cancer that has spread to my brain.I am not pregnant or breast-feeding.I have another type of cancer that might affect this study's results.I haven't had unstable chest pain in the last 6 months.My stomach or intestines are not working properly.I have had a seizure within the last 14 days.
Research Study Groups:
This trial has the following groups:- Group 1: Combination Therapy Dose Expansion-2
- Group 2: Combination Therapy Dose Escalation
- Group 3: Monotherapy Dose Escalation
- Group 4: Monotherapy Therapy Dose Expansion-1
- Group 5: Monotherapy Therapy Dose Expansion-2
- Group 6: Combination Therapy Dose Expansion-1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any prior investigations that focused on Monotherapy Dose Escalation?
"Monotherapy Dose Escalation was first investigated in 2013 at Local Institution - 0046. Subsequent to this, 30 trials have been fully completed and 54 are currently ongoing across the region of San Francisco, California."
Answered by AI
Is this research a pioneering endeavor?
"Monotherapy Dose Escalation began clinical trials in 2013, sponsored by Bristol-Myers Squibb. Following the first study involving 1163 participants, this medication was approved for Phases 1 & 2 of drug development and is now being trialled on 54 different sites across 352 cities and 48 countries globally."
Answered by AI
What is the scope of this trial's implementation across medical centers?
"The trial is administrated from University of California- San Francisco in San Francisco, Stanford University School of Medicine in Stanford and Henry Ford Cancer Institute located in Detroit. Additionally, there are 5 other clinical sites providing services for this study."
Answered by AI
Are there any available slots for participation in this experiment?
"Clinicaltrials.gov confirms that recruitment for this study is ongoing, with the experiment originally posted in June 2020 and updated as recently as September 2022."
Answered by AI
What is the sample size of this medical experiment?
"Yes, the clinicaltrials.gov website confirms that enrollment for this medical experiment is currently underway; it was originally posted on June 16th of 2020 and recently modified on September 16th of 2022. The research requires 48 participants to be recruited from a total of 5 sites."
Answered by AI
What is the regulatory status of Monotherapy Dose Escalation?
"Our experts at Power assigned a score of 1 for the safety assessment of monotherapy dose escalation, as this is an early-stage trial with limited data to support both effectiveness and security."
Answered by AI
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