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Recruiting Phase 1, Phase 2 NCT05689853

Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors

Trial Parameters

Condition Solid Tumor, Adult
Sponsor Akeso
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 87
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-04-14
Completion 2026-12
Interventions
AK119AK112

Brief Summary

This is a Phase Ib/II study to assess the safety, tolerability and preliminary efficacy of AK119 combined with AK112 in patients with advanced solid tumors.

Eligibility Criteria

Inclusion Criteria: 1. Voluntarily written informed consent and agree to comply with all protocol-specified procedures and follow-up evaluations 2. Age ≥ 18 years and ≤ 75 years 3. Histologically or cytologically-confirmed diagnosis of advanced/unresectable solid tumor that have been progressed or intolerant to at least one standard treatment regimen in the advanced or metastatic setting, if such a therapy exists 4. Measurable lesion based on RECIST v1.1 5. ECOG status of 0 or 1 6. Life expectancy ≥ 3 months 7. Adequate organ function 8. Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment Exclusion Criteria: 1. Known other active malignancy within 3 years prior to the first dose of investigational product, with the exception of early stage cancers that have treated with curative intent 2. Currently participating in another st

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