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JNJ-63709178 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Part 1: Dose Escalation | EXPERIMENTAL | Participants will receive JNJ-63709178 in Part 1 (in different cohorts). Each subsequent cohort will receive JNJ-63709178 at an increased dose level. Ascending doses may be given initially to minimize or prevent cytokine release syndrome. Dose escalation will continue until the maximum tolerated dose is reached or all planned doses are administered. |
| Part 2: Dose Expansion | EXPERIMENTAL | Participants will receive JNJ-63709178 at the recommended Phase 2 dose(s) (RP2D) determined in dose expansion phase. |
| Name | Type | Description |
|---|---|---|
| JNJ-63709178 | DRUG | Participants will receive JNJ-63709178 in Part 1 and Part 2. |
Inclusion Criteria: * A diagnosis of acute myeloid leukemia (AML) according to the World Health Organization 2008 criteria with relapsed or refractory disease and ineligible for or have exhausted standard therapeutic options * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 ...
JNJ-63709178 is an investigational small molecule being studied for the treatment of relapsed or refractory acute myeloid leukemia (AML). It is a humanized CD123 x CD3 DuoBody designed to target leukemia cells. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
JNJ-63709178 targets CD123 and CD3. It is a humanized DuoBody that binds to CD123, which is expressed on leukemia cells, and CD3 on T cells, potentially directing the immune system to attack cancer cells. This mechanism is being evaluated in a Phase 1 clinical trial for acute myeloid leukemia.
JNJ-63709178 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 1 clinical development for the treatment of relapsed or refractory acute myeloid leukemia.
JNJ-63709178 is in Phase 1 clinical development. It is an investigational drug being studied for acute myeloid leukemia and has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug remains in early-stage clinical investigation.
JNJ-63709178 has been studied in one clinical trial, identified as NCT02715011. This was a Phase 1 dose escalation study in participants with relapsed or refractory acute myeloid leukemia. The trial enrolled 62 participants and was conducted in the United States and Spain. The trial has been completed.
Yes, JNJ-63709178 is a humanized CD123 x CD3 DuoBody. This means it is a bispecific antibody that binds to both CD123 and CD3. It is being investigated as a potential treatment for acute myeloid leukemia and is currently in Phase 1 clinical development.