Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-64264681 · 3 trials · 4 indications
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
The DLTs are based on drug related adverse events and defined as any of the following events: hematological or non-hematological toxicity of grade 3 or higher (as specified in protocol).
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Cmax is the maximum observed plasma JNJ-64264681 concentration.
Cmax is the maximum observed plasma JNJ-64264681 concentration.
Tmax is defined as actual sampling time to reach maximum observed concentration.
Tmax is defined as actual sampling time to reach maximum observed concentration.
The Tlast is the time to last observed quantifiable plasma concentration.
The Tlast is the time to last observed quantifiable plasma concentration.
AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
AUC (0-24) is the area under the plasma concentration-time curve from time zero to 24 hours.
AUClast is defined as area under the plasma JNJ-64264681 concentration-time curve from time 0 to time of the last observed quantifiable concentration.
AUCtau is area under the plasma JNJ-64264681 concentration-time curve during a dosing interval (tau) at steady-state.
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
t1/2 is apparent elimination half-life of JNJ-64264681 associated with the terminal slope (z) of the semi-logarithmic drug concentration-time curve.
t1/2 is apparent elimination half-life of JNJ-64264681 associated with the terminal slope (z) of the semi-logarithmic drug concentration-time curve.
MAD: Accumulation Ratio obtained by dividing AUC of JNJ-64264681 at two different time points.
| Arm | Type | Description |
|---|---|---|
| Part A: Dose escalation: JNJ-64264681 and JNJ-67856633 | EXPERIMENTAL | Participants will receive JNJ-64264681 and JNJ-67856633 will be administered together until disease progression, intolerable toxicity, withdrawal of consent, or the investigator. |
| Part B: Cohort Expansion: JNJ-64264681 and JNJ-67856633 | EXPERIMENTAL | Participants will receive JNJ-64264681 and JNJ-67856633 at the recommended Phase 2 dose (RP2D) determined in Part 1. |
| JNJ-64264681: Dose Escalation and Expansion | EXPERIMENTAL | Participants will receive oral administration of JNJ-64264681 capsule at a dose assigned by the sponsor Study Evaluation Team (SET), based on the available safety, pharmacokinetics, and pharmacodynamics data in dose escalation treatment group (Part 1); and recommended Phase 2 dose (RP2D) determined in Part 1 in cohort expansion treatment group (Part 2). |
| Single Ascending Dose (SAD) | EXPERIMENTAL | The SAD part will consist of 6 escalating dose cohorts and 1 fed cohort of healthy male participants, 2 dose escalating cohorts of healthy female participants, and 1 solid dose formulation (capsule) cohort of healthy male participants, who will be dosed after completion of the dose escalation cohorts. Participants in each cohort (except for the solid dose formulation cohort) will receive JNJ-64264681 or Placebo on Day 1, orally. In the solid dose formulation cohort, participants will receive JNJ-64264681 capsule on Day 1. Doses for the female cohorts and fed cohort will be selected based on safety, tolerability, pharmacokinetics (PK),and pharmacodynamic (PD) data from preceding cohorts and the dose for the solid dose formulation cohort will be selected and approximately equal to a dose previously studied in the single ascending dose cohorts. |
| Multiple Ascending Dose (MAD) | EXPERIMENTAL | The MAD part will consist of 3 dose escalation cohorts of males and females. Participants will receive once-daily oral doses of JNJ-64264681 or placebo for 10 consecutive days. |
| Name | Type | Description |
|---|---|---|
| JNJ-64264681 | DRUG | JNJ-64264681 capsules will be administered orally. |
| JNJ-67856633 | DRUG | JNJ-67856633 capsules or tablets will be administered orally. |
| Placebo | DRUG | Matching placebo to JNJ-64264681 will be administered as oral solution. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 * Cardiac parameters within the following range: corrected QT interval (QTcF) \<= 480 milliseconds * Participants with B cell non-Hodgkin lymphoma (NHL) must have tumor tissue available at baseline as...
JNJ-64264681 is an investigational small molecule being studied for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia. It has also been evaluated in healthy volunteers to assess its safety, tolerability, and pharmacokinetics. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
JNJ-64264681 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with certain blood cancers.
JNJ-64264681 is in Phase 1 clinical development. All three clinical trials involving the drug have been completed, including studies in healthy volunteers and in patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia. The drug remains investigational and has not received FDA approval.
JNJ-64264681 has been studied in three completed Phase 1 trials. NCT03607513 evaluated the drug in healthy participants in Belgium. NCT04210219 studied it in patients with non-Hodgkin lymphoma and chronic lymphocytic leukemia across multiple countries. NCT04657224 evaluated JNJ-64264681 in combination with another investigational drug, JNJ-67856633, in the same patient populations.
No, JNJ-64264681 and JNJ-67856633 are two different investigational drugs. They were studied together in a Phase 1 clinical trial (NCT04657224) for the treatment of non-Hodgkin lymphoma and chronic lymphocytic leukemia, but they are distinct compounds being developed by Johnson & Johnson.