Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Olverembatinib 20mg
Olverembatinib · 4 trials · 8 indications
Proportion of subjects who do not experience disease progression or death after the first dose of treatment as assessed by Independent Review Committee.
To compare the major molecular response (MMR) rate at 24 weeks of olverembatinib versus bosutinib
To evaluate the MMR rate by 24 weeks of olverembatinib in CML-CP patients with T315I mutation
The minimal residual disease negative CR rate of olverembatinib combined with chemotherapy versus investigator's choice of TKI combined with chemotherapy in subjects with newly diagnosed Ph+ALL.
The C(max) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
The t(max) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The t½ of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The AUC(last) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
The AUC(0-192h) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated and compared.
The CL/F of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The Vz/F of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
The unbound fraction (fu) of a single dose of olverembatinib in participants with impaired hepatic function and controls with normal hepatic function will be evaluated.
| Arm | Type | Description |
|---|---|---|
| Olverembatinib | EXPERIMENTAL | - |
| Part A, RCT, olverembatinib arm and bosutinib arm | OTHER | Randomized controlled part that is designed to compare the efficacy and safety of olverembatinib (investigational arm) versus bosutinib (control arm) in patients with CML-CP, previously treated with at least two TKIs |
| Part B, SAT, olverembatinib arm | OTHER | To evaluate the efficacy and safety of olverembatinib in the CML-CP patients with T315I mutation previously |
| Investigator's choice of TKI | ACTIVE_COMPARATOR | Investigator's choice of TKI in combination with chemotherapy |
| Group 1: 6-8 participants with mild hepatic impairment. | EXPERIMENTAL | - |
| Group 2: 6-8 participants with normal hepatic function matched to Group 1 | EXPERIMENTAL | - |
| Group 3: 6-8 participants with moderate hepatic impairment | EXPERIMENTAL | - |
| Group 4: 6-8 participants with normal hepatic function matched to Group 3 | EXPERIMENTAL | - |
| Group 5: 6-8 participants with severe hepatic impairment | EXPERIMENTAL | - |
| Group 6: 6-8 participants with normal hepatic function matched to Group 5 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Olverembatinib | DRUG | Oral administration with meal, QOD, every 28 days for a cycle. |
| Bosutinib | DRUG | Bosutnib QD |
| Investigator's choice of TKI | DRUG | Oral (PO) once daily (QD). |
| Olverembatinib 20mg | DRUG | orally after meal, single dose |
Inclusion Criteria: 1. Histologically and/or cytologically confirmed GIST, immunohistochemistry with loss of SDHB expression, and failure of at least one prior systemic therapy. Defined as disease progression or intolerable as judged by the investigator. 2. Must have at least one measurable target ...
Olverembatinib is an investigational small molecule being studied for use in oncology. It is in clinical development for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), chronic myeloid leukemia (CML), gastrointestinal stromal tumors (GIST), and pharmacokinetic studies. It is not yet approved and remains in clinical trials.
Olverembatinib targets ABL1 and BCR, acting as an inhibitor of these molecular targets. This mechanism is relevant to its study in BCR-ABL positive leukemias such as Ph+ ALL and chronic myeloid leukemia. The drug is a small molecule designed to interfere with the activity of these proteins.
Olverembatinib is being developed by Ascentage Pharma Group International, whose American Depository Shares trade under the ticker AAPG. The company is conducting clinical trials of this investigational drug across multiple oncology indications, including leukemia and gastrointestinal stromal tumors.
Olverembatinib is in Phase 3 clinical development for Ph+ ALL, chronic myeloid leukemia, and GIST. It is also being studied in a Phase 1 pharmacokinetic trial. The drug is investigational and has not been approved by regulatory authorities, as it is still undergoing clinical evaluation.
Olverembatinib is being studied in several trials. NCT06051409 is a Phase 3 study in newly diagnosed Ph+ ALL. NCT06423911 is a Phase 3 study in chronic-phase CML. NCT06640361 is a Phase 3 study in SDH-deficient GIST. NCT07282093 is a Phase 1 pharmacokinetic study in participants with hepatic impairment.
Yes, Olverembatinib 20mg refers to the same drug, Olverembatinib. The 20mg designation indicates a specific dosage strength of the medication. This naming is used in some contexts to specify the formulation, but it is the same investigational compound being developed by Ascentage Pharma.