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Phase 1b: APG-115+pembrolizumab · 1 trial · 8 indications
Part I is to assess the safety and tolerability of APG-115 by assessing the dose-limiting toxicity (DLT) of APG-115 in combination with pembrolizumab. End points included: Incidence of DLTs during the first 3 weeks of treatment of each dose cohort; Severity and frequency of any adverse event(s) (AE) and serious adverse event(s) (SAE) based on NCI CTCAE 5.0
Part I is aimed to generate data to select the recommended Phase II dose
Phase II is to assess overall response rate of APG-115 as monotherapy and in combination with pembrolizumab defined as the percentage of subjects with a best overall confirmed complete response (CR) or a partial response (PR) at any time as per RECIST 1.1
| Arm | Type | Description |
|---|---|---|
| APG-115+pembrolizumab open label, two-part phase Ib/II | EXPERIMENTAL | single arm dose escalation and dose expansion |
| Name | Type | Description |
|---|---|---|
| Phase 1b: APG-115+pembrolizumab | DRUG | dose escalation of APG-115 in combination with label dose of pembrolizumab, Four dose levels of APG-115 will be tested: 50, 100, 150, and 200 mg. APG-115 will be administrateddose escalation of APG-115 in combination with label dose of pembrolizumab, Fourfour dose levels of APG-115 will be tested: 50, 100, 150, and 200 mg. APG-115 will be administrated orally every other day (QOD) for consecutive 2 weeks (ie. dosed at Day 1, 3, 5, 7, 9, 11, and 13), with one week dosing off as there are cycles every 3-weeks a cycle. Pembrolizumab is administrated following FDA approved label dose, i.e., 200 mg intravenous infusion at Day 1 of every 3 weeks as a cycle. Phase II: Combination of APG-115 at 150 mg (RP2D) and pembrolizumab or APG-115 monotherapy alone. |
Inclusion Criteria: * Male or non-pregnant, non-lactating female patients age ≥18 years, an exception for MPNST cohort: adolescents ≥12 years old (who weigh at least 40 kg) is allowed * Part 2: 1. Measurable disease according to RECIST 1.1. Lesions situated in a previously irradiated area, or an...
APG-115 is an investigational small molecule being studied for the treatment of unresectable or metastatic melanoma or advanced solid tumors. It is being evaluated as a monotherapy or in combination with pembrolizumab in patients with these conditions, including uveal melanoma, cutaneous melanoma, mucosal melanoma, and malignant peripheral nerve sheath tumors.
APG-115 is being developed by Ascentage Pharma Group International, which trades under the ticker AAPG. The company is conducting a Phase 1 clinical trial of APG-115, both as a monotherapy and in combination with pembrolizumab, in patients with metastatic melanomas or advanced solid tumors.
APG-115 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants, and it is studying the drug as a monotherapy or in combination with pembrolizumab.
APG-115 is being studied in a Phase 1 clinical trial with the identifier NCT03611868. The trial is titled "A Study of APG-115 in as a Monotherapy or Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors." It is active but not recruiting, with an enrollment of 230 participants.
No, APG-115 is not the same as pembrolizumab. APG-115 is an investigational small molecule being developed by Ascentage Pharma, while pembrolizumab is a separate drug. The two are being studied in combination in a Phase 1 clinical trial for metastatic melanomas or advanced solid tumors.