ARTEMIS-103: Phase 1b Study of HS-20093 Combinations in Patients with Bone and Soft Tissue Sarcoma.

NCT06699576 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-20093-106
• Study Type: interventional
• Target: 448
• Locations: 0 countries
• Sites: N/A

Brief Summary

HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on bone and soft tissue sarcoma. 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 bone and soft tissue sarcoma.

Conditions

Osteosarcoma; Soft Tissue Sarcoma (STS)

Keywords

Phase 1b; Osteosarcoma; Soft Tissue Sarcoma; HS-20093; B7-H3

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 bone and soft tissue sarcoma.

  Up to day 21 from the first dose

Secondary Outcomes (10)

• 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

• Overall survival (OS)

  From the first dose up to death, assessed up to 24 months

Study Arms (4)

Cohort 1a

EXPERIMENTAL

HS-20093 and Anlotinib

Drug: HS-20093; Drug: Anlotinib

Cohort 1b

EXPERIMENTAL

HS-20093 and Epirubicin

Drug: HS-20093; Drug: Epirubicin

Cohort 1c

EXPERIMENTAL

HS-20093, Epirubicin and Anlotinib

Drug: HS-20093; Drug: Anlotinib; Drug: Epirubicin

Cohort 2a

EXPERIMENTAL

HS-20093 and Adebrelimab

Drug: HS-20093; Drug: Adebrelimab

Interventions

HS-20093 DRUG

HS-20093: administered as an IV infusion

Cohort 1a; Cohort 1b; Cohort 1c; Cohort 2a

Anlotinib DRUG

Anlotinib: 12mg once daily (QD) orally

Cohort 1a; Cohort 1c

Epirubicin DRUG

Epirubicin: administered as an IV infusion

Cohort 1b; Cohort 1c

Adebrelimab DRUG

Adebrelimab: administered as an IV infusion

Cohort 2a

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 osteosarcoma and soft tissue sarcoma
• Cohort1: Dose escalation part will enroll advanced soft tissue sarcoma 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.
• Cohort2: Advanced osteosarcoma patients for which standard treatment has proven ineffective or unavailable or intolerable.
• 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:

• treatment with any of the following:
• Previous or current treatment with B7-H3 targeted therapy
• Previous or current treatment with TOP1i related treatment
• Previous or current treatment with PD-L1 inhibitor (Cohort2 )
• Intolerable for any Anlotinib(Cohort 1a/1c), Anthracyclines (Cohort 1b/1c) and PD-L1 inhibitor (Cohort2 )
• 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

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

MeSH Terms

Conditions

Osteosarcoma; Sarcoma

Interventions

anlotinib; Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Xiaodong Tang, PhD

CONTACT

010-88324561; tang15877@126.com

Study Design

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

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: November 21, 2024

Record last verified: 2024-11