Phase
Condition
Carcinoma
Squamous Cell Carcinoma
Lung Cancer
Treatment
HS-20093
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
At least age of 18 years at screening. 2. Patients,who have progressed on orintolerant to standard therapie,with histologically confirmedrecurrent/metastatic HNSCC or other solid tumor.
At least one measurable lesion according to RECIST 1.1. 4. Agree to providefresh or archival tumor tissue and peripheral blood samples.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1. 6. Lifeexpectancy >= 12 weeks. 7. Men or women should be using adequate contraceptivemeasures throughout the study.
Female subjects must not be pregnant at screening or have evidence ofnon-childbearing potential.
Signed and dated Informed Consent Form.
Exclusion
Exclusion Criteria:
Treatment with any of the following:
Previous or current treatment with B7-H3 targeted therapy
Any cytotoxic chemotherapy, investigational agents and small molecule targetedtherapy within 14 days prior to the first scheduled dose of HS-20093
Prior treatment with macromolecule anti-tumor therapy or other anticancer drugswithin 28 days prior to the first scheduled dose of HS-20093
Radiotherapy with a limited field of radiation for palliation within 2 weeks,or patients received more than 30% of the bone marrow irradiation, orlarge-scale radiotherapy within 4 weeks prior to the first scheduled dose ofHS-20093
Pleural or peritoneal effusion requiring clinical intervention. Pericardialeffusion
Major surgery within 4 weeks of the first dose of HS-20093
Spinal cord compression or brain metastases.
Treatment with drugs that are predominantly CYP3A4 strong inhibitors orinducers or sensitive substrates of CYP3A4 with a narrow therapeutic rangewithin 7 days of the first dose of study drug; or requiring treatment withthese drugs during the study.
Currently receiving drugs known to prolong QT interval or may cause torsade depointe; or requiring treatment with these drugs during the study.
Any unresolved toxicities from prior therapy greater than Grade 2 according toCommon Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exceptionof stable hypothyroidism treated with hormone replacement therapy, alopecia orneurotoxicity.
History of other primary malignancies. 4. Inadequate bone marrow reserve ororgan dysfunction 5. Evidence of cardiovascular risk. 6. Severe, uncontrolledor active cardiovascular diseases. 7. Diabetes ketoacidosis or hyperglycemiahypertonic occurring within 6 months before the first dose of the study drug,or the glycosylated hemoglobin value ≥ 7.5% in the screening period.
Severe or poorly controlled hypertension. 9. Bleeding symptoms with apparentclinical significance or obvious bleeding tendency within 1 months prior to thefirst dose of HS-20093 10. Serious arteriovenous thrombosis events occurredwithin 3 months before the first dose.
Severe infections occurred within 4 weeks before the first dose. 12. Patientswho have received continuous steroid treatment for more than 30 days within 30days before the first dose, or need long-term (≥ 30 days) steroid treatment, orwho have other acquired and congenital immunodeficiency diseases, or have ahistory of organ transplantation 13. The presence of active infectious diseaseshas been known before the first dose such as hepatitis B, hepatitis C,tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.
Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or moresevere cirrhosis.
Other moderate or severe lung diseases that may interfere with the detection ortreatment of drug-related pulmonary toxicity or may seriously affectrespiratory function.
Previous history of serious neurological or mental disorders, includingepilepsy, dementia or severe depression and any other status that may interferein assessment.
Women who are breastfeeding or pregnant or planned to be pregnant during thestudy period.
Vaccination or hypersensitivity of any level within 4 weeks prior to the firstdose of HS-20093 19. History of severe hypersensitivity reaction, severeinfusion reaction or allergy to recombinant human or mouse derived proteins.
Hypersensitivity to any ingredient of HS-20093. 21. Unlikely to comply withstudy procedures, restrictions, and requirements in the opinion of theinvestigator 22. Any disease or condition that, in the opinion of theinvestigator, would compromise subject safety or interfere with studyassessments
Study Design
Study Description
Connect with a study center
Anhui Cancer Hospital
Hefei, Anhui
ChinaActive - Recruiting
Beijing Cancer Hospital
Beijing, Beijing
ChinaActive - Recruiting
Beijing Tongren Hospital, CMU
Beijing, Beijing
ChinaActive - Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
ChinaActive - Recruiting
Sun Yai-Sen Memorial Hospital Sun Yai-Sen University
Guangzhou, Guangdong
ChinaActive - Recruiting
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong
ChinaActive - Recruiting
The Fifth Affiliated Hospital Sun Yat-Sen University
Zhuhai, Guangdong
ChinaActive - Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi
ChinaActive - Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan
ChinaActive - Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
ChinaActive - Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei
ChinaActive - Recruiting
Hunan Cancer Hospital
Changsha, Hunan
ChinaActive - Recruiting
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan
ChinaActive - Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning
ChinaSite Not Available
Liaoning Cancer Hospital
Shenyang, Liaoning
ChinaActive - Recruiting
Cancer Hospital of Shandong First Medical University
Jinan, Shandong
ChinaActive - Recruiting
Shanghai East Hospital
Shanghai, Shanghai 200120
ChinaActive - Recruiting
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai
ChinaActive - Recruiting
The first Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi
ChinaActive - Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan
ChinaActive - Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
ChinaActive - Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin
ChinaActive - Recruiting
Cancer hospital of Xinjiang medical University
Xinjiang, Xinjiang
ChinaActive - Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
ChinaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.