A Study of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HRXG-K-1939 Combined with Adebrelimab 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
HRXG-K-1939
Other Names:
Drug: Adebrelimab
Adebrelimab is a programmed death-ligand 1 antibody
|
Outcome Measures
Primary Outcome Measures
- Dose Escalation Phase:RP2D [9 months]
Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of HRXG-K-1939
- • Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood [Baseline through 12 months after last HRXG-K-1939 dose]
• Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood
Secondary Outcome Measures
- Objective Response Rate(ORR) [12 months]
The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
- Disease Control Rate (DCR) [12 months]
The proportion of patients who have a CR or PR or SD, as determined by the Investigator at local site per RECIST 1.1.
- Duration of Response (DoR) [12 months]
Time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
- Progression Free Survival (PFS) [12 months]
Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.
- Overall Survival (OS) [24 months]
Time to death due to any cause
- Adverse Events(AEs) [From consent to 90 days after the final dose of study drug]
Occurrence of Adverse Events(AEs) graded according to CTCAE v5.0
- Biomarker analysis [Baseline through 12 months after last HRXG-K-1939 dose]
Serum cytokines (IL-10, IL-6, IL-2, TNF- α, IFN- γ ) Changes from baseline condition
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Voluntarily signed the informed consent form and complied with protocols requirements;
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Patients with advanced solid tumors that are suitable for immunotherapy;
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ECOG Performance Status of 0 or 1;
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Life expectancy ≥ 12 weeks;
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At least one measurable disease per RECIST v1.1;
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Tumor specimen availability;
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Adequate marrow and organ function;
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Have resolution of toxic effects from prior therapy to Grade 1 or less (except for Grade ≤2 alopecia or neuropathy) per CTCAE v5.0;
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Patients with fertility are willing to use an adequate method of contraception.
Exclusion Criteria:
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Previously detected positive driver genes (EGFR, ALK, ROS1, etc.);
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Have leptomeningeal, or actively progressing CNS metastases (patients with stable brain metastases can be enrolled);
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Uncontrolled pleural effusion, pericardial effusion, or ascites;
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Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study;
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Prior anti-cancer therapy (e.g., chemotherapy, radiotherapy, hormonal therapy, targeted therapy, immunotherapy, any other investigational or immunomodulatory drugs) within 21 days prior to initiation of study treatment;
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Live-attenuated vaccination within 28 days prior to initiation of study treatment through 60 days after the end of study;
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Systemic steroid therapy or other form of immunosuppressive therapy within 14 days prior to initiation of study treatment;
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Any history of an immune-mediated Grade 4 adverse event or Grade 3 adverse event that resulted in permanent discontinuation;
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Active or history of autoimmune disease;
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Active tuberculosis or infection requiring treatment;
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History of interstitial lung disease;
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Allergic to research drug ingredients;
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Prior malignancy within 5 years prior to study entry;
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Solid organ or allogeneic bone marrow transplant;
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HIV positive, HCV positive, HBV DNA copies ≥ 10^3;
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Significant cardiovascular disease;
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Other situations that are not suitable for inclusion in this study judged by investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fudan University Shanghai Cancer Center | Shanghai | Shanghai | China | 200032 |
Sponsors and Collaborators
- Fudan University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIT-HRXG-K-193