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

NCT ID: NCT05942378

Last Updated: 2023-07-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-12-01

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

HRXG-K-1939

Intervention Type: DRUG

HRXG-K-1939

Adebrelimab

Intervention Type: DRUG

Adebrelimab is a programmed death-ligand 1 antibody

Interventions

HRXG-K-1939

HRXG-K-1939

Intervention Type: DRUG

Adebrelimab

Adebrelimab is a programmed death-ligand 1 antibody

Intervention Type: DRUG

Other Intervention Names

HRXG-K-1939 is a mRNA cancer vaccines

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Jian Zhang,MD

MD, Ph.D

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Countries

China

Facility Contacts

Jian Zhang, MD

Role: primary

Syner2000@163.com

86-021-64175590 ext. 73546

Yanchun Meng, MD

Role: backup

ycmclinicaltrials@126.com

Other Identifiers

IIT-HRXG-K-193

Identifier Type: -

Identifier Source: org_study_id