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Recruiting Phase 2 NCT06003621

Tiragolumab and Atezolizumab in Advanced Pan-cancer Patients

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Trial Parameters

Condition Solid Tumor, Adult
Sponsor Omico
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 96
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-12-15
Completion 2026-05-01
Interventions
TiragolumabAtezolizumab

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Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Provision of written informed consent. 2. Aged ≥18 years old. 3. Histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumour. 4. Exhausted all available standard therapy or not suitable for standard therapy (including targeted therapies) for the tumour. 5. ECOG performance status score of 0-1. 6. Sufficient and accessible tumour tissue for panel sequencing, PD-L1 and TIL testing, and tertiary objectives. 7. Tumour biomarker criteria predictive of immune response defined by presence of one or more of the following; * Group 1: tumour mutation burden ≥ 10 mutations per megabase. * Group 2: PD-L1 amplification \>6 copy number alterations * Group 3: tumour PD-L1 expression TAP score ≥ 5% * Group 4: tumour infiltrating lymphocytes (TILs) (CD3+CD8+) ≥ 5%. 8. Patient is willing to provide tumour biopsy samples on treatment at Week 4. 9. Life expectancy \>12 weeks. 10. Measurable disease as defined by iRECIST or RANO criteria. 11. Ad

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