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Also known as hAd5-HPV Vaccine (IBRX-042), hAd5-HPV Vaccine, IBRX-042 (hAd5-HPV E6.ETSD-IRES-E7.ETSD Vaccine)
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 therapy being studied in adults with HPV-related carcinoma, a group of cancers associated with human papillomavirus infection. It is in Phase 1 clinical development in the United States. The trial enrolls participants 18 years and older and is not currently recruiting new participants.
IBRX-042 targets the HPV E6 and E7 proteins. These viral proteins are expressed in HPV-associated tumors, and the candidate is designed to direct an immune response against cells expressing them. The trial is biomarker-selected, meaning participants are chosen based on characteristics related to the target.
IBRX-042 is being developed by ImmunityBio, Inc., which trades on the Nasdaq under the ticker IBRX. The company is running the Phase 1 study of the candidate in HPV-associated tumors in the United States.
IBRX-042 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single Phase 1 trial, NCT05976828, is active but no longer recruiting, with an planned enrollment of 12 participants.
IBRX-042 is being studied in one clinical trial, NCT05976828, titled "IBRX-042 In Participants With HPV-Associated Tumors." The Phase 1 study is active but not recruiting, enrolls 12 participants, is controlled, and is open to all sexes aged 18 years and older.
Yes. IBRX-042 is also known as the hAd5-HPV Vaccine, and the two names refer to the same investigational candidate. It is being developed by ImmunityBio for HPV-related carcinoma and is currently in Phase 1 testing.