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In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with QL1604 monotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1604 Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1604 | Drug | QL1604, IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (assessed by independent radiological review committee (IRRC) per RECIST Version 1.1 and iRECIST) | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (assessed by the investigators per RECIST Version 1.1 and iRECIST) | up to 2 years |
| 6-month PFS rate | 6-month progression-free survival (PFS) rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shunjiang Yu, CMO | Contact | 0531-83129659 | shunjiang.yu@qilu-pharma.com | |
| Weijian Guo, Professor | Contact | 021-64175590 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Recruiting | Shanghai | Shanghai Municipality | 2000 32 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39529169 | Derived | Bi F, Dong J, Jin C, Niu Z, Yang W, He Y, Yu D, Sun M, Wang T, Yin X, Zhang R, Chen K, Wang K, Wang Z, Li W, Zhang Z, Zhang H, Guo Q, Wang X, Han L, Zhang X, Shen W, Zhang L, Ying J, Wu M, Hu W, Li Z, Li X, Feng W, Zhang B, Li L, Kang X, Guo W. Iparomlimab (QL1604) in patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic solid tumors: a pivotal, single-arm, multicenter, phase II trial. J Hematol Oncol. 2024 Nov 11;17(1):109. doi: 10.1186/s13045-024-01627-5. |
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| the proportion of subjects who have time interval over 6 months between the first dose and disease progression or death |
| 6-month OS rate | 6-month overall survival rate | from the date of first dose until the date of 6-month |
| PFS | Progression-free survival (assessed by independent radiological review committee (IRRC) per RECIST v1.1 and iRECIS) | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years |
| PFS | Progression-free survival (assessed by the investigators per RECIST v1.1 and iRECIST) | from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier), assessed up to 2 years |
| OS | Overall survival | from the date of first dose until the date of death from any causeļ¼ assessed up to 2 years |
| DOR | Duration of response | from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier), assessed up to 2 years |
| West China Hospital, Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|