Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABBV-368 · 2 trials · 1 indication
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Number of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported.
Number of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported.
Maximum Serum Concentration (Cmax) of ABBV-368
Maximum Observed Plasma Concentration (Cmax) of Tilsotolimod
Maximum Observed Serum Concentration (Cmax) of ABBV-181
Time to Maximum Serum Concentration (Tmax) of ABBV-181
Area Under Serum Concentration-Time Curve of ABBV-181 From Time 0 to the Time of Last Measurable Concentration (AUCt)
Terminal-Phase Elimination Rate Constant (β) of ABBV-181
Terminal Half-Life (t1/2) of ABBV-181
Area under the serum concentration-time curve of ABBV-368
The MTD of ABBV-368 when administered as monotherapy or as combination therapy with ABBV-181 will be determined during the dose escalation phase of the study.
Recommended Phase 2 dose (RPTD) for ABBV-368 when administered as monotherapy or as combination therapy with ABBV-181 will be established during the Dose expansion of the study
Time to Cmax of ABBV-368
Terminal phase elimination rate constant of ABBV-368
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
| Arm | Type | Description |
|---|---|---|
| Arm 1: ABBV-368 + Tilsotolimod | EXPERIMENTAL | Participants will be administered ABBV-368 and Tilsotolimod at various timepoints as described in the protocol. |
| Arm 2: ABBV-368 + Tilsotolimod + Nab-paclitaxel | EXPERIMENTAL | Participants will be administered ABBV-368, Tilsotolimod and Nab-paclitaxel at various timepoints as described in the protocol. |
| Arm 3: ABBV-368 + Tilsotolimod + Nab-paclitaxel + ABBV-181 | EXPERIMENTAL | Participants will be administered ABBV-368, Tilsotolimod, Nab-paclitaxel and ABBV-181 at various timepoints as described in the protocol. |
| Part 1A: Monotherapy Dose Escalation | EXPERIMENTAL | Part 1A: ABBV-368 (various dose levels) intravenous administration every 2 weeks (Q2W). One cycle of treatment is 28 days, thus there will be 2 doses with ABBV-368 per cycle. |
| Part 2A: Monotherapy Cohort Expansion | EXPERIMENTAL | Part 2A: Additional participants (triple negative breast cancer \[TNBC\]) will be enrolled in a dose expansion cohort that will further evaluate ABBV-368 (various dose levels) intravenous administration Q4W. |
| Part 2B: Combination Therapy Cohort Expansion | EXPERIMENTAL | Part 2B: Additional participants (with Head and Neck carcinoma) will be enrolled in a dose expansion cohort that will further evaluate ABBV-368 (various dose levels) intravenous administration Q4W plus ABBV-181. |
| Part 3A: 18F-AraG Imaging Substudy in TNBC Participants | EXPERIMENTAL | Part 3A: Additional participants (with TNBC) will be enrolled in 18F-AraG Imaging Substudy that will further evaluate ABBV-368 intravenous administration Q4W plus ABBV-181. |
| Part 3B: 18F-AraG Imaging Substudy in HNSCC Participants | EXPERIMENTAL | Part 3B: Additional participants (with HNSCC) will be enrolled in 18F-AraG Imaging Substudy that will further evaluate ABBV-368 intravenous administration Q4W plus ABBV-181. |
| Name | Type | Description |
|---|---|---|
| ABBV-368 | DRUG | Intravenous (IV) infusion |
| Tilsotolimod | DRUG | Intratumoral (IT) injection |
| Nab-paclitaxel | DRUG | Intravenous (IV) infusion |
| ABBV-181 | DRUG | Intravenous (IV) infusion |
Inclusion Criteria: * Participants should weigh at least 35 kg. * Eastern Cooperative Oncology Group performance status of 0 or 1 and a life expectancy of \>= 3 months. * Participant have \>= 1 lesion accessible for intratumoral injection. * Histologically or cytologically confirmed R/M HNSCC (of t...
ABBV-368 is an investigational small molecule being developed for advanced solid tumors cancer. It is being studied in patients with locally advanced or metastatic solid tumors, including recurrent or metastatic head and neck squamous cell carcinoma. The drug is in Phase 1 clinical development and is not yet approved.
ABBV-368 targets OX40, a receptor involved in immune response. By targeting OX40, the drug is designed to modulate T-cell activity in the tumor microenvironment. This mechanism is being explored as a potential treatment for advanced solid tumors, though the drug remains in early-stage clinical trials.
ABBV-368 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational oncology drug.
ABBV-368 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 169 participants enrolled. The drug is investigational and has not received regulatory approval for any indication.
ABBV-368 has been studied in two completed Phase 1 trials. NCT03071757 evaluated the drug as a single agent and in combination in subjects with advanced solid tumors, enrolling 139 participants across the US, France, Japan, Puerto Rico, Spain, and Taiwan. NCT04196283 tested ABBV-368 plus tilsotolimod and other combinations in head and neck squamous cell carcinoma, enrolling 30 participants.
No, ABBV-368 is not the same as tilsotolimod. ABBV-368 is an OX40-targeting small molecule developed by AbbVie. Tilsotolimod is a separate investigational agent that was studied in combination with ABBV-368 in a Phase 1 trial for head and neck squamous cell carcinoma.