Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-428 · 1 trial · 1 indication
If a maximum tolerated dose (MTD) is reached, the RPTD of ABBV-428 will not be a dose higher than the defined MTD, and will be selected based on the type(s) and occurrence(s) of dose limiting toxicities which occur in addition to the MTD. If a MTD is not reached, then the RPTD will be defined based on the safety and pharmacokinetic data.
The highest dose level at which less than 2 of 6 participants or less than 33% of (if cohort is expanded beyond 6) participants experience a dose limiting toxicity.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | ABBV-428 will be administered at escalating dose levels in 28-day dosing cycles (2 doses per cycle). |
| Arm A, B, and C | EXPERIMENTAL | Additional participants (with ovarian cancer, NSCLC, etc.) will be enrolled in a dose expansion cohorts that will further evaluate ABBV-428. |
| Arm D | EXPERIMENTAL | Additional participants with NSCLC will be enrolled in an expansion cohort that will further evaluate ABBV-428 plus nivolumab. |
| Arm 2 | EXPERIMENTAL | ABBV-428 plus nivolumab. |
| Name | Type | Description |
|---|---|---|
| ABBV-428 | DRUG | ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15. |
| Nivolumab | DRUG | Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules. |
Inclusion Criteria: * Participants must have an advanced solid tumor that has progressed on standard therapies known to provide clinical benefit or the participants are intolerant to such therapies. * Participants have adequate bone marrow, renal, hepatic and coagulation function. * For all dose ex...
ABBV-428 is an investigational small molecule immunotherapy being studied for the treatment of advanced solid tumors cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is intended for patients with advanced solid tumors, a type of cancer that has spread or is not amenable to curative treatment.
ABBV-428 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.
ABBV-428 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The Phase 1 trial has been completed, and the drug is no longer in active clinical trials, but it remains in the early stages of clinical investigation.
ABBV-428 has been studied in one clinical trial, identified as NCT02955251, titled 'A Study of ABBV-428, an Immunotherapy, in Subjects With Advanced Solid Tumors.' This Phase 1 trial was completed and enrolled 61 participants across the United States, Australia, France, and Taiwan. The trial included patients aged 18 years and older.
ABBV-428 is the primary name for this investigational drug, and no alternative names have been reported. It is a distinct small molecule being developed by AbbVie for advanced solid tumors. Patients and healthcare providers should refer to it by its designated name, ABBV-428, in clinical and research contexts.