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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

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