Advanced solid tumors with homologous recombination defect (HRD)
Conditions
Interventions
Single Arm group:Zimberelimab combined with PARPi regimen
Sponsors
Xuzhou Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Over 18 years old, both male and female; 2. Histologically or cytologically confirmed advanced (metastatic and/or unresectable) solid tumors. Subjects must have progressed after receiving standard treatment or cannot tolerate standard treatment, and there is no limit to the number of lines of previous treatment; 3. Positive homologous recombination deficiency (HRD) confirmed by the center; 4. At least 1 measurable lesion meeting RECIST 1.1 criteria; 5. Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1; 6. Life expectancy is >= 3 months; 7. All toxicities due to previous antitumor therapy or surgery were relieved to grade 0 - 1 (according to NCI CTCAE version 5.0) or to baseline levels. Except for other toxicities such as hair loss, fatigue, and hearing loss that the researchers believe do not pose a safety risk to patients; 8. Female subjects of childbearing age must undergo a serum pregnancy test within 7 days before starting the study drug, and the result is negative, and are willing to use a medically recognized high-efficiency contraceptive during the study period and within 6 months after the last administration of the test drug Measures (eg: intrauterine device, contraceptives, or condoms); for male subjects whose partners are females of childbearing age, surgical sterilization, or consent to use an effective method of contraception; 9. Have sufficient organ function; 10. With my consent and signed informed consent, willing and able to comply with the planned visits, research treatment, laboratory examinations and other experimental procedures.
Exclusion criteria
Exclusion criteria: 1. Suffering from other malignant tumors in the past 3 years or at the same time, excluding cured basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, cervical cancer in situ, and breast ductal carcinoma in situ; 2. A history of non-infectious pneumonia/interstitial lung disease, requiring steroid treatment or current pneumonia/interstitial lung disease; 3. History of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML); 4. Known central nervous system metastasis and/or cancerous meningitis; 5. Active infection requiring systemic treatment; 6. Active tuberculosis (Bacillus tuberculosis [TB]); 7. Immunocompromised or undergoing chronic systemic steroid therapy (dose equivalent to >10 mg of prednisone per day) or any other form of immunosuppressive therapy 7 days prior to the first dose of study treatment; 8. Have active autoimmune disease requiring systemic therapy (ie, use of corticosteroids or immunosuppressive drugs) within the past two years; 9. Receive colony-stimulating factors (such as granulocyte mass stimulating factor [G-CSF], granulocyte-macrophage population stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days before the first administration of the study drug; 10. Known history of human immunodeficiency virus (HIV) infection; 11. Known active hepatitis B or C; 12. Received programmed death receptor-1 inhibitor (PD-1), programmed death ligand 1 inhibitor (PD-L1), programmed death ligand 2 inhibitor (PD-L2), cytotoxicity T lymphocyte-associated protein 4 (CTLA-4), OX 40 [tumor necrosis factor receptor superfamily, member 4 (TNFRSF4)], CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)], or other receptors that act on T Drugs/antibodies for cellular co-stimulatory or checkpoint pathways; 13. Has received PARPi or any other PARPi (poly(ADP-ribose) polymerase inhibitor) treatment; 14. Received systemic anti-tumor treatment including study medication within 4 weeks before study treatment; 15. Known to be allergic to the test drug or any excipients; or to have had a severe allergic reaction to other monoclonal antibodies; 16. Received homologous bone marrow transplantation or double umbilical cord transplantation (dUCBT); 17. Received systemic blood transfusion within 120 days before the start of the study; 18. Received radiation therapy within 2 weeks before the start of the study; 19. Received major surgery within 28 days before the first administration of the study drug. The definition of major surgery in this study: at least 3 weeks of recovery time is required after the operation before the surgery treated in this study can be accepted. 20. Received live vaccine within 30 days before the first administration of the study drug; 21. Those who have received allogeneic tissue/solid organ transplantation in the past; 22. Patients deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Quality of Life Sale;Safety;Progression-Free Survival;Duration of Response; | — |
Countries
China
Contacts
Public ContactWang Xiang
Xuzhou Central Hospital
Outcome results
None listed