Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Azirkitug · 1 trial · 7 indications
An 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.
Maximum Observed Serum Concentration (Cmax) of azirkitug.
Time to maximum Observed Serum Concentration (Tmax) of azirkitug.
Terminal elimination half-life (t1/2) of azirkitug.
Area under the serum concentration versus time curve (AUC) of azirkitug.
Incidence and concentration of azirkitug anti-drug antibodies.
Incidence and concentration of azirkitug neutralizing anti-drug antibodies.
Cmax of budigalimab.
Tmax of budigalimab.
t1/2 of budigalimab.
AUC of budigalimab.
Incidence and concentration of budigalimab ADA.
Incidence and concentration of budigalimab nADA.
Cmax of telisotuzumab adizutecan.
Tmax of telisotuzumab adizutecan.
t1/2 of telisotuzumab adizutecan.
AUC of telisotuzumab adizutecan.
Incidence and concentration of telisotuzumab adizutecan ADA.
Incidence and concentration of telisotuzumab adizutecan nADA.
| Arm | Type | Description |
|---|---|---|
| Part 1 Dose Escalation: Azirkitug | EXPERIMENTAL | Participants will receive Azirkitug. |
| Part 1 Dose Escalation: Azirkitug + Budigalimab | EXPERIMENTAL | Participants will receive Azirkitug in combination with budigalimab. |
| Part 2 Dose Expansion: Azirkitug | EXPERIMENTAL | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion. |
| Part 2 Dose Expansion: Azirkitug + Budigalimab | EXPERIMENTAL | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
| Part 3 Dose Expansion: Azirkitug + Budigalimab | EXPERIMENTAL | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
| Part 4 Dose Expansion: Azirkitug | EXPERIMENTAL | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion. |
| Part 4 Dose Expansion: Azirkitug + Budigalimab | EXPERIMENTAL | Participants will receive Azirkitug in combination with budigalimab. |
| Part 4 Dose Optimization and Randomization: Azirkitug | EXPERIMENTAL | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion. |
| Part 4 Dose Optimization & Randomization Azirkitug+Budigalimab | EXPERIMENTAL | Participants will receive Azirkitug in combination with budigalimab. |
| Part 5 Dose Expansion: Azirkitug + Budigalimab | EXPERIMENTAL | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
| Part 6 Dose Expansion: Azirkitug + Budigalimab | EXPERIMENTAL | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
| Part 7 Dose Expansion: Azirkitug + Budigalimab | EXPERIMENTAL | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
| Part 8 Safety Lead In: Azirkitug + Bevacizumab | EXPERIMENTAL | Participants will receive Azirkitug in combination with bevacizumab. |
| Part 8 Dose Expansion: Azirkitug + Bevacizumab | EXPERIMENTAL | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with bevacizumab. |
| Part 9 Dose Expansion: Azirkitug + Budigalimab | EXPERIMENTAL | Participants will receive Azirkitug at recommended dose determined in Dose Escalation portion in combination with budigalimab. |
| Part 10 Safety Lead In: Azirkitug + Telisotuzumab Adizutecan | EXPERIMENTAL | Participants will receive Azirkitug in combination with telisotuzumab adizutecan. |
| Part 10 Dose Expansion: Azirkitug+Telisotuzumab Adizutecan | EXPERIMENTAL | Participants will receive Azirkitug at recommended dose determined in the safety lead in portion in combination with telisotuzumab adizutecan. |
| Name | Type | Description |
|---|---|---|
| Azirkitug | DRUG | Intravenous (IV) Infusion |
| Budigalimab | DRUG | Intravenous (IV) Infusion |
| Bevacizumab | DRUG | Intravenous (IV) Infusion |
| Telisotuzumab Adizutecan | DRUG | Intravenous (IV) Infusion |
Inclusion Criteria: * Pre Treatment biopsy or archive tissue within 6 months without intervening treatment * Eastern Cooperative Oncology Group (ECOG) performance status of \<= 0 or 1 and a life expectancy of \>= 3 months. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIS...
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Azirkitug is an investigational therapy being studied in adults with non-small cell lung cancer. It is also being evaluated in head and neck squamous cell carcinoma and other advanced solid tumors, including micro satellite stable colorectal, gastric/esophageal, high-grade serous ovarian, pancreatic, and triple negative breast cancer.
Azirkitug is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The single ongoing trial is a Phase 1 study evaluating adverse events and pharmacokinetics in adult participants with non-small cell lung cancer and other solid tumors.
Azirkitug is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the Phase 1 clinical program evaluating the drug in non-small cell lung cancer and other advanced solid tumors.
Azirkitug is being studied in one active clinical trial, NCT05005403. The trial is currently recruiting and has an estimated enrollment of 694 participants. It is a controlled Phase 1 study evaluating intravenous Azirkitug alone or in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan.
The Azirkitug Phase 1 trial NCT05005403 is recruiting participants across the United States, Canada, Israel, Japan, South Korea, and Taiwan. It enrolls adults aged 18 years and older with non-small cell lung cancer, head and neck squamous cell carcinoma, and other advanced solid tumors.
Yes, the Azirkitug Phase 1 trial NCT05005403 is biomarker selected, meaning enrollment is guided by specific biomarker criteria. The study evaluates intravenous Azirkitug alone or in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan in adults with non-small cell lung cancer and other solid tumors.