A Study of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Efficacy and Safety of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05942378
• Other study ID #: IIT-HRXG-K-193
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: July 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• HRXG-K-1939
HRXG-K-1939
• Adebrelimab
Adebrelimab is a programmed death-ligand 1 antibody

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Escalation Phase:RP2D	Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of HRXG-K-1939	9 months
Primary	• 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
Secondary	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
Secondary	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.	12 months
Secondary	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
Secondary	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
Secondary	Overall Survival (OS)	Time to death due to any cause	24 months
Secondary	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
Secondary	Biomarker analysis	Serum cytokines (IL-10, IL-6, IL-2, TNF- a, IFN- ? ) Changes from baseline condition	Baseline through 12 months after last HRXG-K-1939 dose