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This is a Phase 1, open-label study evaluating the efficacy and safety of HRXG-K-1939 in combination with Adebrelimab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in patients with advanced solid tumors. HRXG-K-1939 will be administered to patients in a dose escalation regimen to determine a recommended dose for expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRXG-K-1939 Combined with Adebrelimab | Experimental | Dose Escalation: HRXG-K-1939 at escalated dosages with Adebrelimab Experimental: Dose Expansion HRXG-K-1939 at recommended dose with Adebrelimab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRXG-K-1939 | Drug | HRXG-K-1939 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation Phase:RP2D | Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of HRXG-K-1939 | 9 months |
| • Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood | • Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood | Baseline through 12 months after last HRXG-K-1939 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1. | 12 months |
| Disease Control Rate (DCR) | The proportion of patients who have a CR or PR or SD, as determined by the Investigator at local site per RECIST 1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
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| Adebrelimab | Drug | Adebrelimab is a programmed death-ligand 1 antibody |
|
| 12 months |
| Duration of Response (DoR) | Time from the date of first documented response until the date of documented progression or death in the absence of disease progression. | 12 months |
| Progression Free Survival (PFS) | Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause. | 12 months |
| Overall Survival (OS) | Time to death due to any cause | 24 months |
| Adverse Events(AEs) | Occurrence of Adverse Events(AEs) graded according to CTCAE v5.0 | From consent to 90 days after the final dose of study drug |
| Biomarker analysis | Serum cytokines (IL-10, IL-6, IL-2, TNF- α, IFN- γ ) Changes from baseline condition | Baseline through 12 months after last HRXG-K-1939 dose |