Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IBRX-042 · 1 trial · 1 indication
The rate of DLTs will be assessed and the MTD determined
| Arm | Type | Description |
|---|---|---|
| First Dose Level | EXPERIMENTAL | Dose Cohort 1: IBRX -042 1e11 virus particles per dose |
| Second Dose Level | EXPERIMENTAL | Dose Cohort 2: IBRX-042 5e11 virus particles per dose |
| De-escalation Dose Level | EXPERIMENTAL | Dose Cohort -1: IBRX-042 5e10 virus particles per dose |
| Name | Type | Description |
|---|---|---|
| IBRX-042 | DRUG | * Dose cohort 1: 1e11 virus particles (VP)/dose * Dose cohort 2: 5e11 VP/dose * If needed, dose cohort -1 (de-escalation): 5e10 VP/dose |
Inclusion Criteria: 1. 18-75 years of age. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Histologically confirmed HPV-associated cancer documented as HPV- or p16-positive c...
IBRX-042 is an investigational small molecule being developed for the treatment of HPV-related carcinoma. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.
IBRX-042 is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol IBRX. The company is conducting clinical research to evaluate the drug's potential in treating HPV-associated tumors.
IBRX-042 is in Phase 1 clinical development. This is the earliest stage of human testing, focused primarily on assessing the drug's safety, tolerability, and preliminary activity. The drug is investigational and has not received FDA approval.
IBRX-042 is being studied in a Phase 1 clinical trial with the identifier NCT05976828, titled 'IBRX-042 In Participants With HPV-Associated Tumors.' This single trial is active but not recruiting participants, with a planned enrollment of 12 patients in the United States.
IBRX-042 is a small molecule therapeutic, but its specific molecular target has not been disclosed. The drug is being investigated for its potential to treat HPV-related carcinoma, a type of cancer associated with human papillomavirus infection.
No, IBRX-042 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The drug has not yet completed the clinical development process required to establish its safety and efficacy for regulatory approval.