A Study of AK104 in Subjects With Locally Advanced Unresectable or Metastatic MSI-H/dMMR Solid Tumors
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|ClinicalTrials.gov Identifier: NCT04547101|
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : September 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|MSI-H/dMMR Solid Tumor||Drug: AK104||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-arm, Open-label, Multicenter, Phase II Study of AK104, a PD-1/CTLA-4 Bispecific Antibody, in Subjects With Locally Advanced Unresectable or Metastatic Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Solid Tumors|
|Actual Study Start Date :||April 24, 2020|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||December 31, 2021|
AK104，6 mg/kg IV，every 2 weeks (Q2W)
- Objective response rate (ORR) [ Time Frame: Up to 2 years ]ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.
- Disease control rate (DCR) [ Time Frame: Up to 2 years ]DCR is defined as the proportion of subjects with confirmed CR, PR, or SD, based on RECIST v1.1
- Duration of response (DoR) [ Time Frame: Up to 2 years ]DoR is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
- Progression-free survival (PFS) [ Time Frame: Up to 2 years ]PFS is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first.
- Overall survival (OS) [ Time Frame: Up to 2 years ]OS is defined as the time from the start of treatment with AK104 until death due to any cause.
- Adverse events (AEs) [ Time Frame: From first dose of AK104 through to 90 days after last dose of AK104 ]Incidences of treatment-emergent adverse events (TEAEs) , treatment-related adverse events (TRAEs) as assessed by CTCAE v5.0
- Observed pharmacokinetics (PK) exposure of AK104 [ Time Frame: From first dose of AK104 through to 90 days after last dose of AK104 ]The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration.
- Number of subjects who develop detectable anti-drug antibodies (ADAs) [ Time Frame: From first dose of AK104 through to 90 days after last dose of AK104 ]The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable ADAs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547101
|Contact: Xiaoping Jin, PhD||+86 (0760) 8987 firstname.lastname@example.org|
|Sun Yat-Sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510000|
|Contact: Ruihua Xu, M.D +86 (020) 8734 3333 email@example.com|
|Principal Investigator:||Ruihua Xu, MD||Sun Yat-sen University|