Trial Title:
ARTEMIS-006: HS-20093 in Patients With Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
NCT ID:
NCT06007729
Condition:
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HS-20093
Description:
Participants in all subjucts will receive HS-20093 at 10mg/kg
Arm group label:
HS-20093 (phase 2a and Phase 2b)
Summary:
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds
to B7-H3, a target wildly expressed on solid tumor cells.
This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety,
pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with
head and neck squamous cell carcinoma and other solid tumors.
Detailed description:
This is a phase 2, open-label, multi-center study consisting of two parts: Phase 2a and
2b.
Phase 2a: The study will be conducted in the following two cohorts: Cohort 1: Patients
with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) who have
progressed on or intolerant to standard therapies. Cohort 2: Other patients with advanced
solid tumors if they have progressed on or intolerant to available standard therapies, or
no standard or available curative therapy exists. All subjects will receive 10.0 mg/kg of
HS-20093.
Phase 2b: The study will be conducted in patients with recurrent/metastatic HNSCC who
have progressed on or intolerant to standard therapies. Subjects will receive 10.0 mg/kg
of HS-20093.
All patients will be carefully followed for adverse events during the study treatment and
for 90 days after the last dose of HS-20093. Subjects will be permitted to continue
therapy with assessments for progression if the product is well tolerated and sustained
clinical benefit exists.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
-
1. At least age of 18 years at screening. 2. Patients，who have progressed on or
intolerant to standard therapie，with histologically confirmed
recurrent/metastatic HNSCC or other solid tumor.
3. At least one measurable lesion according to RECIST 1.1. 4. Agree to provide
fresh or archival tumor tissue and peripheral blood samples.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1. 6. Life
expectancy >= 12 weeks. 7. Men or women should be using adequate contraceptive
measures throughout the study.
8. Female subjects must not be pregnant at screening or have evidence of
non-childbearing potential.
9. Signed and dated Informed Consent Form.
Exclusion Criteria:
-
1. Treatment with any of the following:
1. Previous or current treatment with B7-H3 targeted therapy
2. Any cytotoxic chemotherapy, investigational agents and small molecule targeted
therapy within 14 days prior to the first scheduled dose of HS-20093
3. Prior treatment with macromolecule anti-tumor therapy or other anticancer drugs
within 28 days prior to the first scheduled dose of HS-20093
4. Radiotherapy with a limited field of radiation for palliation within 2 weeks,
or patients received more than 30% of the bone marrow irradiation, or
large-scale radiotherapy within 4 weeks prior to the first scheduled dose of
HS-20093
5. Pleural or peritoneal effusion requiring clinical intervention. Pericardial
effusion
6. Major surgery within 4 weeks of the first dose of HS-20093
7. Spinal cord compression or brain metastases.
8. Treatment with drugs that are predominantly CYP3A4 strong inhibitors or
inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range
within 7 days of the first dose of study drug; or requiring treatment with
these drugs during the study.
9. Currently receiving drugs known to prolong QT interval or may cause torsade de
pointe; or requiring treatment with these drugs during the study.
2. Any unresolved toxicities from prior therapy greater than Grade 2 according to
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception
of stable hypothyroidism treated with hormone replacement therapy, alopecia or
neurotoxicity.
3. History of other primary malignancies. 4. Inadequate bone marrow reserve or
organ dysfunction 5. Evidence of cardiovascular risk. 6. Severe, uncontrolled
or active cardiovascular diseases. 7. Diabetes ketoacidosis or hyperglycemia
hypertonic occurring within 6 months before the first dose of the study drug,
or the glycosylated hemoglobin value ≥ 7.5% in the screening period.
8. Severe or poorly controlled hypertension. 9. Bleeding symptoms with apparent
clinical significance or obvious bleeding tendency within 1 months prior to the
first dose of HS-20093 10. Serious arteriovenous thrombosis events occurred
within 3 months before the first dose.
11. Severe infections occurred within 4 weeks before the first dose. 12. Patients
who have received continuous steroid treatment for more than 30 days within 30
days before the first dose, or need long-term (≥ 30 days) steroid treatment, or
who have other acquired and congenital immunodeficiency diseases, or have a
history of organ transplantation 13. The presence of active infectious diseases
has been known before the first dose such as hepatitis B, hepatitis C,
tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.
14. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more
severe cirrhosis.
15. Other moderate or severe lung diseases that may interfere with the detection or
treatment of drug-related pulmonary toxicity or may seriously affect
respiratory function.
16. Previous history of serious neurological or mental disorders, including
epilepsy, dementia or severe depression and any other status that may interfere
in assessment.
17. Women who are breastfeeding or pregnant or planned to be pregnant during the
study period.
18. Vaccination or hypersensitivity of any level within 4 weeks prior to the first
dose of HS-20093 19. History of severe hypersensitivity reaction, severe
infusion reaction or allergy to recombinant human or mouse derived proteins.
20. Hypersensitivity to any ingredient of HS-20093. 21. Unlikely to comply with
study procedures, restrictions, and requirements in the opinion of the
investigator 22. Any disease or condition that, in the opinion of the
investigator, would compromise subject safety or interfere with study
assessments
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Cancer Hospital
Address:
City:
Hefei
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Facility:
Name:
Beijing Tongren Hospital, CMU
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Sun Yai-Sen Memorial Hospital Sun Yai-Sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
The Fifth Affiliated Hospital Sun Yat-Sen University
Address:
City:
Zhuhai
Country:
China
Status:
Recruiting
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Country:
China
Status:
Recruiting
Facility:
Name:
Harbin Medical University Cancer Hospital
Address:
City:
Harbin
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Facility:
Name:
The Second XIANGYA Hospital Of Central South University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Facility:
Name:
The Second Hospital of Dalian Medical University
Address:
City:
Dalian
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Liaoning Cancer Hospital
Address:
City:
Shenyang
Country:
China
Status:
Recruiting
Facility:
Name:
Cancer Hospital of Shandong First Medical University
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200120
Country:
China
Status:
Recruiting
Contact:
Last name:
Ye Guo, MD
Phone:
13501678472
Email:
pattrickguo@gmail.com
Facility:
Name:
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Facility:
Name:
The first Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Facility:
Name:
Cancer hospital of Xinjiang medical University
Address:
City:
Xinjiang
Country:
China
Status:
Recruiting
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Start date:
December 18, 2023
Completion date:
December 12, 2027
Lead sponsor:
Agency:
Hansoh BioMedical R&D Company
Agency class:
Industry
Source:
Hansoh BioMedical R&D Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06007729
