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

Condition(s) studied

Investigational drug(s) / intervention(s)

Azirkitug: Intravenous (IV) Infusion

Budigalimab: Intravenous (IV) Infusion

Bevacizumab: Intravenous (IV) Infusion

Telisotuzumab Adizutecan: Intravenous (IV) Infusion

Study summary

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of azirkitug as a monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan.

Bevacizumab is an approved product, while budigalimab, azirkitug, and telisotuzumab adizutecan are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The maximum-tolerated dose (MTD)/maximum administered dose (MAD) of azirkitug will be explored. Each treatment arm receives a different dose of azirkitug in monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Approximately 694 adult participants will be enrolled in the study across approximately 80 sites worldwide.

Participants will receive azirkitug as a monotherapy or in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan as an Intravenous (IV) Infusion for an estimated treatment period of up to 2 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility

Primary outcome measure(s)

• Number of Participants with Adverse Events (AE) — Up to 2 Years
  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 — Up to 2 Years
  Maximum Observed Serum Concentration (Cmax) of azirkitug.
• Time to Maximum Observed Serum Concentration (Tmax) of Azirkitug — Up to 2 Years
  Time to maximum Observed Serum Concentration (Tmax) of azirkitug.
• Terminal Elimination Half-Life (t1/2) of Azirkitug — Up to 2 Years
  Terminal elimination half-life (t1/2) of azirkitug.
• Area Under the Serum Concentration Versus Time Curve (AUC) of Azirkitug — Up to 2 Years
  Area under the serum concentration versus time curve (AUC) of azirkitug.
• Azirkitug Antidrug Antibody (ADA) — Up to 2 Years
  Incidence and concentration of azirkitug anti-drug antibodies.
• Azirkitug Neutralizing Antidrug Antibody (nADA) — Up to 2 Years
  Incidence and concentration of azirkitug neutralizing anti-drug antibodies.
• Cmax of Budigalimab — Up to 2 Years
  Cmax of budigalimab.
• Tmax of Budigalimab — Up to 2 Years
  Tmax of budigalimab.
• t1/2 of Budigalimab — Up to 2 Years
  t1/2 of budigalimab.
• AUC of Budigalimab — Up to 2 Years
  AUC of budigalimab.
• Budigalimab ADA — Up to 2 Years
  Incidence and concentration of budigalimab ADA.
• Budigalimab nADA — Up to 2 Years
  Incidence and concentration of budigalimab nADA.
• Cmax of Telisotuzumab Adizutecan — Up to 2 Years
  Cmax of telisotuzumab adizutecan.
• Tmax of Telisotuzumab Adizutecan — Up to 2 Years
  Tmax of telisotuzumab adizutecan.
• t1/2 of Telisotuzumab Adizutecan — Up to 2 Years
  t1/2 of telisotuzumab adizutecan.
• AUC of Telisotuzumab Adizutecan — Up to 2 Years
  AUC of telisotuzumab adizutecan.
• Telisotuzumab Adizutecan ADA — Up to 2 Years
  Incidence and concentration of telisotuzumab adizutecan ADA.
• Telisotuzumab Adizutecan nADA — Up to 2 Years
  Incidence and concentration of telisotuzumab adizutecan nADA.

Trial sites (48)

+ 8 more sites — see the full list on the official registry below.

On this site

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