NCT06003621

Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients

A Single Arm, Open-label, Phase II Signal-seeking Trial of Tiragolumab and Atezolizumab in Patients With Advanced Solid Tumours.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Omico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II study will explore the effect of 2 monoclonal antibodies, tiragolumab and atezolizumab, in patients with locally advanced solid cancers which cannot be removed by surgery or have spread. Their cancers will have characteristics which may predict immune response to the study treatment. PD-L1 and TIGIT are immune receptors which can help cancers grow by evading the immune response and inhibiting the action of some immune cells. By blocking these receptors, tiragolumab and atezolizumab may work together to re-activate the body's anti-tumour immune response and kill cancer cells.

Detailed description

Patients who are enrolled in the MoST or CaSP cancer screening programs, and whose tumour is assessed as amenable to tiragolumab and atezolizumab treatment, will be recommended for participation in the study. After being informed about the study, and the potential risks, patients who consent to participate undergo a 21-day screening period to determine study eligibility. Patients will be prospectively selected into subgroups based on their tumour characteristics. Once eligibility is confirmed, tiragolumab alone is administered at Cycle 1 Day 1 (day 1 of study). Commencing from Cycle 2 Day 1, tiragolumab and atezolizumab are administered at 21-day cycles until treatment discontinuation, with or without disease progression. Participants undergo a biopsy at cycle 2 prior to commencement of atezolizumab treatment. Standard imaging scans (usually computed tomography (CT)) are performed throughout the trial. Patients also undergo blood, urine and stool sample collection on study. Once participants discontinue treatment, a study visit is performed within 30 days of the end of the final treatment cycle. If treatment cessation is not contemporaneous with disease progression, follow-up calls are conducted every 9 weeks until disease progression. Once disease progression occurs, a study visit is performed within 30 days of disease progression and then every 3 months until 12 months after the final participant discontinues study treatment. Active follow-up of all participants will continue until death or 12 months after the last participant discontinues study treatment, whichever occurs first. Subsequently, survival data will be obtained through MoST or CaSP until death.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
BIOLOGICAL	Tiragolumab	600mg IV every 21 days from Cycle 1 Day 1
BIOLOGICAL	Atezolizumab	1,200mg IV every 21 days from Cycle 2 Day 1

Timeline

• Start date: 2023-12-15
• Primary completion: 2026-05-01
• Completion: 2028-11-01
• First posted: 2023-08-22
• Last updated: 2024-11-15

Locations

13 sites across 1 country: Australia