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~9 spots leftby Jan 2026

ABM-1310 + Cobimetinib for Cancer

Palo Alto (17 mi)

Overseen bySarina A Piha-Paul, M.D.

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: ABM Therapeutics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a Phase I, First-In-Human, open label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-cancer activity of ABM-1310 in adult patients with locally advanced or metastatic solid tumors who have no effective standard treatment options available, as monotherapy in patients with documented BRAF V600 mutation, or in combination with cobimetinib (Cotellic®) in adult patients who have documented BRAF mutation and progressive disease or intolerance to at least one prior line of systemic therapy.

Eligibility Criteria

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.

Inclusion 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.

My brain tumor is smaller than 3 cm.

My melanoma has spread to my brain and tests positive for the BRAF mutation.

My advanced cancer has a positive BRAF mutation.

I am fully active or able to carry out light work.

My advanced cancer has a BRAF V600 mutation.

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.

Exclusion Criteria

I have cancer that has spread to the lining of my brain and spinal cord.

I have an active Hepatitis B or C infection.

I have a blood cancer, such as leukemia, lymphoma, or multiple myeloma.

I do not have any severe illnesses or conditions that are not under control.

I am currently on blood thinners like warfarin.

I have not had a heart attack in the last 6 months.

I do not have significant heart problems.

I am a woman who can have children and do not use birth control.

My heart's pumping ability is below 45%.

I am on medication that affects my heart's rhythm and cannot change it.

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 am not pregnant or breast-feeding.

Treatment Details

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.

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.