ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors

NCT06332170 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HS-20093-103
• Study Type: interventional
• Target: 610
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) for combination-treatments

  To determine the MTD for further evaluation of HS-20093 with other anti-cancer agents in subjects with advanced solid tumors

  Up to day 21 from the first dose

Secondary Outcomes (15)

• Incidence and severity of adverse events (AEs)

  From the first dose through 90 days post end of treatment

• Objective response rate (ORR) determined by investigators

  From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months

• Disease control rate (DCR) determined by investigators

  From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months

• Duration of response (DoR) determined by investigators

  From the first dose up to PD or death, whichever came first, assessed up to 24 months

• Progression-free survival (PFS) determined by investigators according to RECIST 1.1

  From the first dose up to PD or death, whichever came first, assessed up to 24 months

Study Arms (5)

Cohort 1a

EXPERIMENTAL

HS-20093 and Adebrelimab

Drug: HS-20093; Drug: Adebrelimab

Cohort 1b

EXPERIMENTAL

HS-20093, Adebrelimab and Cisplatin/ Carboplatin

Drug: HS-20093; Drug: Adebrelimab; Drug: Cisplatin/ Carboplatin

Cohort 2a

EXPERIMENTAL

HS-20093 and Cetuximab

Drug: HS-20093; Drug: Cetuximab

Cohort 2b

EXPERIMENTAL

HS-20093, Cetuximab and Cisplatin/ Carboplatin

Drug: HS-20093; Drug: Cisplatin/ Carboplatin; Drug: Cetuximab

Cohort 3a

EXPERIMENTAL

HS-20093 and Enzalutamide

Drug: HS-20093; Drug: Enzalutamide

Interventions

HS-20093 DRUG

administered as an IV infusion

Cohort 1a; Cohort 1b; Cohort 2a; Cohort 2b; Cohort 3a

Adebrelimab DRUG

administered as an IV infusion

Cohort 1a; Cohort 1b

Cisplatin/ Carboplatin DRUG

administered as an IV infusion

Cohort 1b; Cohort 2b

Cetuximab DRUG

administered as an IV infusion

Cohort 2a; Cohort 2b

Enzalutamide DRUG

160mg once daily (QD) orally

Cohort 3a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least age of 18 years at screening;
• Histologically or cytologically confirmed, locally advanced or metastatic solid tumors
• Dose escalation part will enroll advanced solid tumor for which standard treatment has proven ineffective or unavailable or intolerable.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Interventions

Cisplatin; Carboplatin; Cetuximab; enzalutamide

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Hua Zhong, PhD

CONTACT

(0086)021-22200000; shsxkyy@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 27, 2024
• Study Start: April 26, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2028
• Last Updated: July 18, 2024

Record last verified: 2024-07

Locations

CN (1)