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 small molecule being developed for the treatment of Non-Small Cell Lung Cancer. It is also being studied in other solid tumors including Head and Neck Squamous Cell Carcinoma, Micro Satellite Stable Colorectal Cancer, Gastric/Esophageal Cancer, High-Grade Serous Ovarian Cancer, Pancreatic Cancer, and Triple Negative Breast Cancer.
Azirkitug is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 1 clinical development.
Azirkitug is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a single active Phase 1 trial that is currently recruiting participants.
Azirkitug is being studied in one active Phase 1 clinical trial, identified as NCT05005403. This trial is assessing adverse events and pharmacokinetics in adult participants with Non-Small Cell Lung Cancer and other solid tumors, receiving Azirkitug alone or in combination with other agents. The trial is recruiting and has a target enrollment of 694 participants.
No, Azirkitug is a distinct investigational drug. In clinical trial NCT05005403, Azirkitug is being studied alone and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. These are separate agents being evaluated alongside Azirkitug in the same trial.