Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as [14C] HQP1351
HQP1351 · 4 trials · 4 indications
EFS is defined as any "event" occurred since randomization, such as disease progression.
Use liquid scintillation counter to evaluate Radioactivity concentration of each blood and plasma sample
Use liquid scintillation counter to evaluate Radioactivity concentration of each urine sample
Use liquid scintillation counter to evaluate Radioactivity concentration of each feces sample
Calculate the total radioactivity in urine and feces based on the radioactivity concentration of each sample
Area under the plasma concentration-time curve from time zero extrapolated to infinity time of HQP1351.
Area under the plasma concentration-time curve from time zero to the last measurable time point of HQP1351.
Percentage of area under the concentration time curve from time zero extrapolated to infinite time obtained by extrapolation of HQP1351.
Maximum observed plasma concentration of HQP1351.
Time to maximum observed plasma concentration of HQP1351.
Terminal elimination half life (T1/2) is defined as the duration until observation of half of the maximum concentration of HQP1351.
Apparent clearance of HQP1351 following oral dosing. Clearance of a drug is a measure of rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose of HQP1351 (apparent oral clearance) is influenced by the fraction of dose absorbed.
Apparent volume of distribution of HQP1351. Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution of HQP1351 after oral dose (Vz/F) is influenced by the fraction absorbed.
Patients with HQP1351 treatment related adverse events (AE), serious adverse events (SAE) will be assessed according NCI CTCAE Version 4.03.
| Arm | Type | Description |
|---|---|---|
| HQP1351 therapy cohort | EXPERIMENTAL | HQP1351 40 mg, taken orally once every other day of a 28-day cycle |
| Best Available Therapy (BAT) cohort | ACTIVE_COMPARATOR | Best available therapy (BAT) will be selected by the investigator for each participant. |
| [14C] HQP1351 | EXPERIMENTAL | To investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose (30mg, 100µCi) of \[14C\] HQP1351 to healthy Chinese male subjects. |
| A group | EXPERIMENTAL | Subjects in the group A will be given HQP1351 after fasting meal on Day 1. Then after a seven-day of cleaning time, subjects in the group A will be given HQP1351 after 30 minutes of high-fat meal on Day 8. |
| B group | EXPERIMENTAL | Subjects in the group B will be given HQP1351 after 30 minutes of high-fat meal on Day 1. Then after a seven-day of cleaning time, subjects in the group B will be given HQP1351 after fasting meal on Day 8. |
| HQP1351 30mg | EXPERIMENTAL | 30 mg QOD(Minor subjects will be enrolled based on weight) |
| HQP1351 40mg | EXPERIMENTAL | 40 mg QOD(Minor subjects will be enrolled based on weight) |
| HQP1351 50mg | EXPERIMENTAL | 50 mg QOD |
| HQP1351 20mg | EXPERIMENTAL | 20 mg QOD (Minor subjects will be enrolled based on weight) |
| Name | Type | Description |
|---|---|---|
| HQP1351 | DRUG | HQP1351 is a new, bioavailable inhibitor against BCRABLWT and a broad spectrum of BCR-ABL mutants including BCR-ABLT315I |
| Hydroxyurea or Interferon-based therapy | DRUG | Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines. |
| Homoharringtonine | DRUG | Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines. |
| Imatinib, Dasatinib or Nilotinib | DRUG | Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines. |
| [14C] HQP1351 | DRUG | Orally, single dose of 30mg |
Inclusion Criteria: 1. Male or non-pregnant, non-lactating female patients who are 18 years of age or older. 2. CML-CP patients with positive Ph chromosome or BCR-ABL fusion genes. 3. Resistance and intolerance of first- and second-generation TKIs: defined as resistance or intolerance to imatinib, ...
HQP1351 is an investigational small molecule being studied for the treatment of chronic myeloid leukemia (CML), including chronic phase CML, and for gastrointestinal stromal tumor (GIST) and other advanced solid tumors. It is being developed by Ascentage Pharma Group International (ticker: AAPG).
HQP1351 targets BCR-ABL1, a tyrosine kinase. By inhibiting this target, the drug is designed to interfere with the signaling that drives chronic myeloid leukemia cells. This mechanism underlies its investigation in CML and related conditions.
HQP1351 is being developed by Ascentage Pharma Group International, whose American Depositary Shares trade under the ticker AAPG. The company is advancing the drug in clinical trials for chronic myeloid leukemia and gastrointestinal stromal tumors.
HQP1351 is in clinical development. Trials registered to date include Phase 1 and Phase 2 studies. It is investigational and has not been approved by the FDA for any indication.
Registered trials include NCT04126707, a completed Phase 1 absorption, metabolism, and excretion study; NCT04126681, a completed Phase 2 pivotal study in chronic phase CML; NCT03882281, a completed Phase 1 pharmacokinetics study; and NCT03594422, a recruiting Phase 1 study in GIST and other solid tumors.
Yes, [14C] HQP1351 is an alternative name for HQP1351. The carbon-14 labeled form was used specifically in a clinical trial (NCT04126707) to study the absorption, metabolism, and excretion of the drug in humans.