Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05005403 | Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan | PHASE1 | RECRUITING | 694 | — | — | Nov 1, 2021 | Jul 1, 2027 | May 13, 2026 | 45 | United States, Canada +4 |
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...