Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors (NCT04190628) | Clinical Trial Compass
TerminatedPhase 1
Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors
Stopped: Not related to safety concerns or lack of efficacy
United States53 participantsStarted 2020-06-16
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male and female subjects age 18 years and older who are able to sign informed consent and to comply with the protocol
. Patients with histologically or cytologically-documented, locally advanced, or metastatic solid tumor malignancy that has either (a) progressed on at least one line of prior standard systemic therapy, (b) for which no standard therapy exists, or (c) standard therapy is not considered appropriate by the patient or treating physician. There is no limit to the number of prior treatment regimens
. C-1: Patients with primary central nervous system (CNS) tumors and documentation of positive BRAF V600 mutation
. C-2: Patients with advanced or metastatic solid tumors and documentation of positive BRAF V600 mutation excluding primary CNS tumor
. C-3: Patients with advanced or metastatic solid tumors and documentation of positive BRAF mutation including primary CNS tumors but excluding melanoma with brain metastasis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)
Timeframe: End of Cycle 1 (each cycle is 28 days) or up to treatment discontinuation (an average of 6 months)
2
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Timeframe: Up to study discontinuation (an average of 1 year)
3
Number of participants with abnormal laboratory values
Timeframe: Up to study discontinuation (an average of 1 year)
. C-4: Patients with melanoma with brain metastasis and documentation of positive BRAF 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.
. ECOG performance status of 0 or 1 or Karnofsky performance status of ≥ 70
Exclusion criteria
. Women who are pregnant or breast-feeding
. Women of child-bearing potential (WOCBP) who does not use adequate birth control
. Patients with any hematologic malignancy. This includes leukemia, lymphoma, and multiple myeloma
. Have a second primary malignancy that, in the judgment of the investigator, may affect the interpretation of results
. Patients with carcinomatous meningitis (leptomeningeal disease (LMD))
. Patients with history of stroke ≤ 6 months prior to starting study drug
. Patients who have had an experience of seizure within 14 days prior to first treatment
. Impaired cardiac function or clinically significant cardiac diseases, including but not limited to any of the following: