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The purpose of the study is to evaluate the safety and tolerability of HLX60 combined with HLX10 in order to determine the maximum tolerated dose (MTD) and Recommended Phase 2 dose (RP2D) and to evaluate the preliminary efficacy for each combination regimen.
Accelerated titration and "3 + 3" dose escalation were used in this trial . various doses of HLX60(anti-GARP) combined with HLX10(anti-PD-1) by intravenous infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLX60 combined with HLX10 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX60 combined with HLX10 | Biological | five various doses of HLX60 combined with flat dose of HLX10 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse event | Incidence and severity of adverse events graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 for patients receiving study drug. | Through study completion, assessed up to 2 years. |
| Incidence of DLT | Ratio of the number of patients with DLT events in each dose group to the number of patients in the dose group during the DLT evaluation period. | Up to 3 weeks. |
| MTD | The maximum tolerated dose (MTD) of HLX60 combined with HLX10 | Up to 3 weeks. |
| RP2D | The recommended phase II dose (RP2D) of HLX60 combined with HLX10 | Through study completion, assessed up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Percentage of patients with complete response or partial response determined by investigators according to RECIST v1.1 | Through study completion, assessed up to 2 years. |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Macquarie University Hospital & Nepean Hospital | Sydney | Australia |
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PFS is defined as the time from the first administration of HLX60 and HLX10 to the first occurrence of disease progression or death due to any cause, whichever occurs first.
| Through study completion, assessed up to 2 years. |
| Overall survival(OS) | OS is defined as the time from the first administration of HLX60 to death due to any cause. | Through study completion, assessed up to 2 years. |
| Cmax | serum concentration (Cmax) | 1 year |
| Tmax | time to reach Cmax (Tmax) | 1 year |
| t1/2 | elimination half-life (t1/2) | 1 year |
| AUC | area under the serum concentration-time curve (AUC) | 1 year |
| PD | include the GARP receptor occupancy on Treg cells, tumor infiltrating lymphocytes (TILs), FOXP3, pSMAD 2/3 in tumor tissues. | 1 year |
| immunogenicity of HLX60 | Incidence of HLX60 anti-drug antibody (ADA) and neutralizing antibody (NAb) | 1 year |
| Potential prognostic and predictive biomarkers | include the expressions of GARP, PD-L1 in tumor tissues and soluble GARP in peripheral blood. | 1 year |