GH55 Capsule is a novel, highly selective small molecule dual mechanism ERK1/2 inhibitor. GH21 Capsule is a potent, orally active human SHP2 allosteric inhibitor. The combination of an ERK1/2 inhibitor and an SHP2 inhibitor achieves a dual effect: synergistic upstream and downstream blockade of the aberrantly activated RTK MAPK signaling pathway, as well as complementation of resistance mechanisms. This study will evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of GH55 Capsule in combination with GH21 Capsule in patients with advanced solid tumors with aberrantly activated MAPK signaling pathway, and investigate the efficacy of this combination regimen in the same patient population.
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Phase Ia: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (according to NCI CTCAE 5.0).
Timeframe: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ia: Dose Limited Toxicity (DLT)
Timeframe: 28 Days (first cycle)
Phase Ib and Phase II: Progression-Free Survival (PFS)
Timeframe: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.
Phase Ib and Phase II: Objective response rate (ORR)
Timeframe: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment. Approximately 2 years.