Stopped: Not related to safety concerns or lack of efficacy
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.
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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)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Timeframe: Up to study discontinuation (an average of 1 year)
Number of participants with abnormal laboratory values
Timeframe: Up to study discontinuation (an average of 1 year)