Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients

Sponsor
Omico
Study ID
NCT06003621
Phase
PHASE2
Status
Recruiting
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Conditions

  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tiragolumab — BIOLOGICAL
    600mg IV every 21 days from Cycle 1 Day 1
  • Atezolizumab — BIOLOGICAL
    1,200mg IV every 21 days from Cycle 2 Day 1

Study Details

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.

Key Dates

Start date
Dec 15, 2023
Status verified
Jun 2024
Primary completion
May 1, 2026
Completion
Nov 1, 2028

Study Design

Enrollment
96 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Tiragolumab and atezolizumab
    96 patients will be treated with tiragolumab for one cycle (600mg IV over 60-90 minutes). At Cycle 2 Day 1, participants receive IV tiragolumab (600mg) and atezolizumab (1,200mg) over 60-90 minutes. Cycles of tiragolumab and atezolizumab repeat every 21 days, with infusion time decreased (if tolerable) until treatment discontinuation, with or without disease progression. Because of the heterogeneity of eligible cancer types, and lack of knowledge about relevant cut-offs for this combination, analysis will be performed prospectively to allocate patients into 4 subgroups based on the following tumour characteristics; * Group 1: TMB ≥ 10, assessed using NGS panel screening. n=24 * Group 2:Tumour and immune cell PD-L1 expression (TAP score) \> 20% high or PD-L1 (CD274) amplification, defined as gene copy number \> 6 on the panel. n=24 * Group 3: Tumour and immune cell PD-L1 expression (TAP score) 5% - 20% int. n=24 * Group 4: Tumour infiltrating lymphocytes CD3+CD8+ ≥ 5%. n=24

Primary Outcome Measure

Progression Free Survival (PFS) rate at 6 Months [ Time Frame: 6 months ]

Central Contacts

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