Clinical trial · Interventional
A Study of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors
A Phase 1 Study to Evaluate the Efficacy and Safety of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors
NCT05942378CI-TRIAL-00067938unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebrelimab | Drug | Adebrelimab | ALIAS |
| HRXG-K-1939 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HRXG-K-1939 Combined with Adebrelimab
- description
- Dose Escalation: HRXG-K-1939 at escalated dosages with Adebrelimab Experimental: Dose Expansion HRXG-K-1939 at recommended dose with Adebrelimab
- interventionNames
- Drug: HRXG-K-1939
- Drug: Adebrelimab
Primary outcomes (2)
- measure
- Dose Escalation Phase:RP2D
- timeFrame
- 9 months
- description
- Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of HRXG-K-1939
- measure
- • Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood
- timeFrame
- Baseline through 12 months after last HRXG-K-1939 dose
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.