Advanced Solid Tumors
Conditions
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.
Interventions
DRUGHRXG-K-1939
HRXG-K-1939
DRUGAdebrelimab
Adebrelimab is a programmed death-ligand 1 antibody
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily signed the informed consent form and complied with protocols requirements; 2. Patients with advanced solid tumors that are suitable for immunotherapy; 3. ECOG Performance Status of 0 or 1; 4. Life expectancy ≥ 12 weeks; 5. At least one measurable disease per RECIST v1.1; 6. Tumor specimen availability; 7. Adequate marrow and organ function; 8. Have resolution of toxic effects from prior therapy to Grade 1 or less (except for Grade ≤2 alopecia or neuropathy) per CTCAE v5.0; 9. Patients with fertility are willing to use an adequate method of contraception.
Exclusion criteria
1. Previously detected positive driver genes (EGFR, ALK, ROS1, etc.); 2. Have leptomeningeal, or actively progressing CNS metastases (patients with stable brain metastases can be enrolled); 3. Uncontrolled pleural effusion, pericardial effusion, or ascites; 4. 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; 5. 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; 6. Live-attenuated vaccination within 28 days prior to initiation of study treatment through 60 days after the end of study; 7. Systemic steroid therapy or other form of immunosuppressive therapy within 14 days prior to initiation of study treatment; 8. Any history of an immune-mediated Grade 4 adverse event or Grade 3 adverse event that resulted in permanent discontinuation; 9. Active or history of autoimmune disease; 10. Active tuberculosis or infection requiring treatment; 11. History of interstitial lung disease; 12. Allergic to research drug ingredients; 13. Prior malignancy within 5 years prior to study entry; 14. Solid organ or allogeneic bone marrow transplant; 15. HIV positive, HCV positive, HBV DNA copies ≥ 10\^3; 16. Significant cardiovascular disease; 17. Other situations that are not suitable for inclusion in this study judged by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed