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

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: HRXG-K-1939; Drug: Adebrelimab

• Registration Number: NCT05942378
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-21
• Status Verified: 2023-07
• Study Start: 2023-07-01
• Study First Submitted QC: 2023-07-04
• Last Update Submitted: 2023-07-04
• Study First Posted: 2023-07-12
• Last Update Posted: 2023-07-12
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HRXG-K-1939 Combined with Adebrelimab	HRXG-K-1939	Dose Escalation: HRXG-K-1939 at escalated dosages with Adebrelimab Experimental: Dose Expansion HRXG-K-1939 at recommended dose with Adebrelimab
HRXG-K-1939 Combined with Adebrelimab	Adebrelimab	Dose Escalation: HRXG-K-1939 at escalated dosages with Adebrelimab Experimental: Dose Expansion HRXG-K-1939 at recommended dose with Adebrelimab

Primary Outcome Measures

Name	Time	Method
• 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
Dose Escalation Phase:RP2D	9 months	Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of HRXG-K-1939

Secondary Outcome Measures

Name	Time	Method
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.
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.
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
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.
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

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China