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

ConditionsOsteosarcomaSoft Tissue Sarcoma (STS)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHansoh BioMedical R&D Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 )

Trial design

Design model

Sequential

Treatments tested in this trial

  • HS-20093

    Drug

    HS-20093: administered as an IV infusion

  • Anlotinib

    Drug

    Anlotinib: 12mg once daily (QD) orally

  • Epirubicin

    Drug

    Epirubicin: administered as an IV infusion

  • Adebrelimab

    Drug

    Adebrelimab: administered as an IV infusion

Treatment groups

448 Participants
are divided into 4 treatment groups
Group A: Cohort 1aExperimental treatment 2 interventions
Group B: Cohort 1bExperimental treatment 2 interventions
Group C: Cohort 1cExperimental treatment 3 interventions
Group D: Cohort 2aExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
Up to day 21 from the first dose

Secondary outcomes

1

Objective response rate (ORR) determined by investigators

Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat).

Time frame
From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months
2

Disease control rate (DCR) determined by investigators

Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose\].

Time frame
From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months
3

Duration of response (DoR) determined by investigators

DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].

Time frame
From the first dose up to PD or death, whichever came first, assessed up to 24 months
4

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

PFS was defined as the time from random assignment or first dose to PD or death from any cause

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hansoh BioMedical R&D Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: