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Trial Title:
A Study of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors
NCT ID:
NCT05942378
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Vaccines
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRXG-K-1939
Description:
HRXG-K-1939
Arm group label:
HRXG-K-1939 Combined with Adebrelimab
Other name:
HRXG-K-1939 is a mRNA cancer vaccines
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Adebrelimab is a programmed death-ligand 1 antibody
Arm group label:
HRXG-K-1939 Combined with Adebrelimab
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Jian Zhang, MD
Phone:
86-021-64175590
Phone ext:
73546
Email:
Syner2000@163.com
Contact backup:
Last name:
Yanchun Meng, MD
Email:
ycmclinicaltrials@126.com
Start date:
July 1, 2023
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05942378
