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 kinase inhibitor being studied for Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), chronic myeloid leukemia (CML), and SDH-deficient gastrointestinal stromal tumors (GIST). It is also being evaluated in a pharmacokinetic study in participants with hepatic impairment.
Olverembatinib is a small molecule that belongs to the -tinib class of kinase inhibitors. It works by targeting and inhibiting specific kinases involved in cancer cell growth and survival. The drug is being studied across multiple oncology indications, including Ph+ ALL, CML, and GIST.
Olverembatinib is being developed by Ascentage Pharma Group International, which trades under the ticker AAPG on the American Depository Shares market. The company is conducting multiple clinical trials of the drug across various oncology indications.
Olverembatinib is in Phase 3 clinical development for Ph+ ALL, chronic myeloid leukemia, and SDH-deficient GIST. It is also in a Phase 1 pharmacokinetic study. The drug is investigational and has not been approved by regulatory authorities.
Olverembatinib is being studied in several recruiting trials: NCT06051409 for newly diagnosed Ph+ ALL with 350 participants, NCT06423911 for chronic-phase CML with 285 participants, NCT06640361 for SDH-deficient GIST with 40 participants, and NCT07282093 for pharmacokinetics in hepatic impairment with 48 participants.
Yes, Olverembatinib is also known as Olverembatinib 20mg. This alternative name refers to the same drug substance, which is being investigated in clinical trials for multiple oncology indications including Ph+ ALL, CML, and GIST.