Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-75348780 · 2 trials · 7 indications
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes.
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.
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening, and Grade 5= Death related to adverse event.
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.
| Arm | Type | Description |
|---|---|---|
| Long Term Safety Assessment (Platform Study) | OTHER | The platform rollover study provides continued long-term access to study treatment(s) (JNJ-64264681; JNJ-67856633 (safimaltib); JNJ-54179060 (ibrutinib); JNJ-75348780; JNJ-74856665; JNJ-64619178; JNJ-70218902; JNJ-80948543; JNJ-87801493) for participants currently receiving the active study treatment in parent studies and deriving benefit from it. Eligible participants in parent study will rollover to this platform study which will be adapted into Intervention Specific Appendix (ISA) within the platform study. Participants will initiate the platform study under the relevant ISA, and will continue to receive study treatment at the dose they received in parent study. |
| Part A: Dose Escalation | EXPERIMENTAL | Participants will receive JNJ-75348780. The dose levels will be escalated sequentially based on the decisions of the Study Evaluation Team (SET), along with the potential exploration of other routes of administration and schedules, until one or more recommended Phase 2 Doses (RP2D) have been identified. |
| Part B: Cohort Expansion | EXPERIMENTAL | Participants will receive JNJ-75348780 at one of the putative RP2Ds determined in Part A. |
| Name | Type | Description |
|---|---|---|
| JNJ-75348780 | DRUG | Participants from the parent study (75348780LYM1001 \[NCT04540796\]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-75348780. |
| JNJ-67856633 | DRUG | Participants from the parent studies (64264681LYM1002 \[NCT04657224\], 67856633LYM1002 \[NCT04876092\] and 67856633LYM1001 \[NCT03900598\]) who are deriving benefit from study treatment will continue to receive JNJ-67856633 orally. |
| JNJ-54179060 | DRUG | Participants from the parent study (67856633LYM1002 \[NCT04876092\]) who are deriving benefit from study treatment will continue to receive JNJ-54179060 orally. |
| JNJ-64264681 | DRUG | Participants from the parent studies (64264681LYM1001 \[NCT04210219\], 64264681LYM1002 \[NCT04657224\]) who are deriving benefit from study treatment will continue to receive JNJ-64264681 orally. |
| JNJ-74856665 | DRUG | Participants from the parent study (74856665AML1001 \[NCT04609826\]) who are deriving benefit from study treatment will continue to receive JNJ-74856665 orally. |
| JNJ-70218902 | DRUG | Participants from the parent study (70218902EDI1001 \[NCT04397276\]) who are deriving benefit from study treatment will continue to receive JNJ-70218902 orally. |
| JNJ-64619178 | DRUG | Participants from the parent study (64619178EDI1001 \[NCT03573310\]) who are deriving benefit from study treatment will continue to receive JNJ-64619178 orally. |
| JNJ-80948543 | DRUG | Participants from the parent studies (80948543LYM1001 \[NCT05424822\]; and 80948543LYM1002 \[NCT06660563\]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-80948543. |
| JNJ-87801493 | DRUG | Participants from the parent study (87801493LYM1001 \[NCT06139406\]) who are deriving benefit from study treatment will continue to receive subcutaneous JNJ-87801493 in combination with subcutaneous JNJ-80948543. |
Inclusion Criteria: * Have participated in a parent study, with a linked intervention specific appendix (ISA) within this platform study, in which they initially received study treatment(s) prior to rolling over to this platform study * Satisfy all ISA specific inclusion criteria * Sign an informed...
JNJ-75348780 is an investigational small molecule being studied for the treatment of acute myeloid leukemia and non-Hodgkin lymphoma. It is in Phase 1 clinical development by Johnson & Johnson (NYSE: JNJ). The drug is also being evaluated in a rollover study for continued treatment and ongoing safety monitoring across multiple cancer types.
JNJ-75348780 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker JNJ. The drug is currently in Phase 1 clinical trials for oncology indications, including acute myeloid leukemia and non-Hodgkin lymphoma.
JNJ-75348780 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The primary Phase 1 study has been completed, and a rollover study is currently enrolling participants by invitation.
JNJ-75348780 has been studied in clinical trial NCT04540796, a Phase 1 study in participants with non-Hodgkin lymphoma and chronic lymphocytic leukemia, which has been completed. A rollover study, NCT06788509, is currently enrolling by invitation for continued treatment and ongoing safety monitoring across multiple cancer types.
JNJ-75348780 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is a small molecule being developed by Johnson & Johnson for oncology indications, and it is distinct from other drugs in the company's pipeline.