A Phase 1 interventional study of HRXG-K-1939 and Adebrelimab in Advanced Solid Tumors, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by Fudan University · Phase 1, Interventional, and Treatment
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.
Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.
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Exclusion Criteria:
Dose Escalation: HRXG-K-1939 at escalated dosages with Adebrelimab Experimental: Dose Expansion HRXG-K-1939 at recommended dose with Adebrelimab
Drug: HRXG-K-1939 · Drug: Adebrelimab
HRXG-K-1939
Also known as: HRXG-K-1939 is a mRNA cancer vaccines
Adebrelimab is a programmed death-ligand 1 antibody
Dose Escalation Phase:RP2D
Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of HRXG-K-1939
Time frame: 9 months
• Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood
• Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood
Time frame: Baseline through 12 months after last HRXG-K-1939 dose
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Overall Survival (OS)
Time to death due to any cause
Time frame: 24 months
Adverse Events(AEs)
Occurrence of Adverse Events(AEs) graded according to CTCAE v5.0
Time frame: 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
Time frame: Baseline through 12 months after last HRXG-K-1939 dose
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jul 2023; primary completion for Sep 2025, 26 months later.
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This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adebrelimab