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Trial Title:
ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors
NCT ID:
NCT06332170
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Carboplatin
Cetuximab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HS-20093
Description:
administered as an IV infusion
Arm group label:
Cohort 1a
Arm group label:
Cohort 1b
Arm group label:
Cohort 2a
Arm group label:
Cohort 2b
Arm group label:
Cohort 3a
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
administered as an IV infusion
Arm group label:
Cohort 1a
Arm group label:
Cohort 1b
Intervention type:
Drug
Intervention name:
Cisplatin/ Carboplatin
Description:
administered as an IV infusion
Arm group label:
Cohort 1b
Arm group label:
Cohort 2b
Intervention type:
Drug
Intervention name:
Cetuximab
Description:
administered as an IV infusion
Arm group label:
Cohort 2a
Arm group label:
Cohort 2b
Intervention type:
Drug
Intervention name:
Enzalutamide
Description:
160mg once daily (QD) orally
Arm group label:
Cohort 3a
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. The objectives of this study
are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of
HS-20093 in combination with other anti-cancer agents in patients with advanced solid
tumor patients.
Detailed description:
This is a phase 1, open-label, multi-center, dose-escalation and expansion, phase 1 study
in Chinses subjects with advanced solid tumors. This study is in design allowing
assessment of safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093
in combination with other anti-cancer agents.
A total of 5 combination-treatments will be carried out in 3 cohorts. The target
population of dose escalation part is patients have progressed on or intolerant to
available standard therapies, and the dose expansion part will enroll patients who have
not received prior treatment for advanced/metastatic disease.
All patients will be carefully followed for adverse events during the study treatment and
for 90 days after the last dose of study drug. 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:
- At least age of 18 years at screening;
- Histologically or cytologically confirmed, locally advanced or metastatic solid
tumors
1. Dose escalation part will enroll advanced solid tumor for which standard
treatment has proven ineffective or unavailable or intolerable.
2. Dose expansion part will enroll patients who have not received prior treatment
for advanced/metastatic disease.
- least one extra-cranial measurable lesion according to RECIST 1
- Agree to provide fresh or archival tumor tissue
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1
- Life expectancy >= 12 weeks
- Agree to use medically accepted methods of contraception
- Men or women should be using adequate contraceptive measures throughout the study;
- Females subjects must not be pregnant at screening or have evidence of
non-childbearing potential
- Signed and dated Informed Consent Form
Exclusion Criteria:
- Any of the following would exclude the subject from participation in the study:
treatment with any of the following: Previous or current treatment with B7-H3 targeted
therapy Intolerable for any PD-L1 inhibitor, cetuximab, enzalutamide and cisplatin/
carboplatin Cytotoxic chemotherapy, investigational agents and anticancer drugs within 14
days prior to the first scheduled dose of HS-20093 Prior treatment with a monoclonal
antibody within 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, or large-scale radiotherapy within 4 weeks prior to
the first scheduled dose of HS-20093 Major surgery within 4 weeks prior to the first
scheduled dose of HS-20093
- Subjects with previous or concurrent malignancies
- Inadequate bone marrow reserve or organ dysfunction
- Evidence of cardiovascular risk
- Evidence of current severe or uncontrolled systemic diseases
- Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled
dose of HS-20093
- Known active infection requiring antibodies treatment within 2 weeks, or severe
infection within 4 weeks prior to the first scheduled dose of HS-20093
- Subjects with current infectious diseases
- History of neuropathy or mental disorders
- Pregnant or lactating female
- History of severe hypersensitivity reaction, severe infusion reaction or
idiosyncrasy to drugs chemically related to HS-20093 or any of the components of
HS-20093
- Unlikely to comply with study procedures, restrictions, and requirements in the
opinion of the investigator
- 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:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Hua Zhong, PhD
Phone:
(0086)021-22200000
Email:
shsxkyy@hotmail.com
Start date:
April 26, 2024
Completion date:
May 30, 2028
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/NCT06332170