Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
APG-3288 · 1 trial · 7 indications
A DLT is defined as any treatment-related adverse event (TRAE) meeting protocol-specified toxicity criteria occurring during the DLT evaluation period (Cycle 1). DLTs will be assessed in participants receiving escalating dose levels of APG-3288 to evaluate its safety and tolerability.
The incidence of treatment emergent adverse events (TEAEs), including Grade 3-5 TEAEs, serious adverse events (SAEs), TEAEs leading to dose interruption, dose reduction, or treatment discontinuation, and deaths, will be assessed in participants receiving APG-3288 in Part 1 (dose escalation) and Part 2 (dose expansion) of the study.
The MTD and/or RP2D of APG-3288 will be determined during the dose escalation phase based on the incidence of DLTs, overall safety, tolerability, and available pharmacokinetic and pharmacodynamic data.
| Arm | Type | Description |
|---|---|---|
| Part 1 (Dose Escalation Phase) | EXPERIMENTAL | APG-3288 at multiple dose levels will be evaluated to determine the recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD). |
| Part 2 (Dose Expansion Phase) | EXPERIMENTAL | Indications and dose cohorts to be determined from Part 1 |
| Name | Type | Description |
|---|---|---|
| APG-3288 | DRUG | Orally administered daily; 28 days per cycle. |
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) status ≤ 1 in Part 1 (dose escalation), and ≤ 2 in Part 2 (dose expansion). * Part 1 (Dose Escalation): histologically or cytologically confirmed diagnosis of R/R CLL/SLL, DLBCL (including Richter Transformation), MCL, WM, MZL, or ...
APG-3288 is an investigational small molecule being developed for the treatment of relapsed/refractory hematological malignancies, including chronic lymphocytic leukemia/small lymphocytic lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma, Waldenström macroglobulinemia, marginal zone lymphoma, and follicular lymphoma. It is currently in Phase 1 clinical development.
APG-3288 targets BTK, a protein involved in B-cell receptor signaling. By inhibiting BTK, the drug aims to disrupt signaling pathways that support the survival and proliferation of malignant B cells. This mechanism is being studied in patients with relapsed/refractory blood cancers.
APG-3288 is being developed by Ascentage Pharma Group International, a biopharmaceutical company listed on the NASDAQ under the ticker AAPG. The company is conducting clinical trials of APG-3288 in the United States and China.
APG-3288 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 study is recruiting patients with relapsed/refractory hematological malignancies to evaluate the drug's safety and preliminary efficacy.
APG-3288 is being studied in a Phase 1 clinical trial with the identifier NCT07424833. The trial, titled "A Study of APG-3288 in Relapsed/Refractory Blood Cancers," is recruiting up to 180 participants aged 18 years and older in the United States and China. It is an open-label, controlled study.
APG-3288 is a distinct investigational compound developed by Ascentage Pharma. No alternative names for APG-3288 have been reported. It is a small molecule BTK inhibitor being evaluated specifically for relapsed/refractory hematological malignancies in a Phase 1 clinical trial.