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Advanced Solid TumorPhase 1NCT05276609

ARTEMIS-001: Phase 1 Study of the HS-20093 in Patients With Advanced Solid Tumors

A Phase 1 study testing HS-20093 (Phase Ia: Dose escalation) and HS-20093 (Phase Ib: Dose expansion) in people with Advanced Solid Tumor, run by Shanghai Hansoh Biomedical Co., Ltd at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 Chinese advanced solid tumor patients. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
HS-20093 (Phase Ia: Dose escalation) and HS-20093 (Phase Ib: Dose expansion)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
177 participants
Where
1 siteChina
Study dates
28 Nov 2021to 31 Dec 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least age of 18 years at screening;
  • Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable
  • At 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
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  • 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

Who cannot join

  • 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
  • Any 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
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  • 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
  • Known vaccination or hypersensitivity of any level within 4 weeks prior to the first scheduled dose 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

Trial locations and contacts

1 site in 1 country.

Jie Wang, PhD contact

13910704669

zlhuxi@163.com

China1 site, 1 recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

    Jie Wang, 13910704669, zlhuxi@163.com

    Recruiting

Other trials in China

About this study

Official title: ARTEMIS-001: A Phase 1, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Doses of Intravenous Administration of HS-20093 in Patients With Locally Advanced or Metastatic Solid Tumors Who Have Progressed Following Prior Therapy

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 Chinese advanced solid tumor patients.

This is a phase 1, open-label, multi-center, dose-escalation and expansion study evaluating the safety, tolerability, pharmacokinetic (PK), and the therapeutic potential of HS-20093 as a monotherapy in subjects with advanced solid tumors.

Read the detailed description

This is an open-label, multi-center, dose-escalation and expansion, first-in-human phase 1 study in Chinese adult participants with locally advanced or metastatic solid tumors. This study will consist of two parts: A Part Ia dose escalation stage and a Part Ib dose expansion stage.

The objectives of this study are to evaluate the safety, tolerability, PK and preliminary anti-tumor activity, describe the dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of HS-20093.

Part Ia: Participants with advanced cancer are eligible for dose escalation study if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. The dose escalation will include an initial accelerated titration design followed by i3+3 design.

Part Ib: Enrollment into dose expansion will begin after identification of the MTD or MAD in Phase Ia. The dose expansion study will be conducted in populations with the following indications: locally advanced or metastatic non- small cell lung cancer (NSCLC)，extensive stage small cell lung cancer (ES-SCLC) and other types of advanced solid tumor.

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.

Being tested
HS-20093 (Phase Ia: Dose escalation), HS-20093 (Phase Ib: Dose expansion)
Keywords
Advanced solid tumor, B7-H3, antibody-drug conjugate (ADC), HS-20093

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-20093 (Phase Ia: Dose escalation)Drug

    Intravenous (IV) administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

  • HS-20093 (Phase Ib: Dose expansion)Drug

    IV administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.

Study groups in NCT05276609
Study groupRoleWhat they receive
HS-20093 (Phase Ia: Dose escalation)ExperimentalThere are seven escalating dose cohorts.
Receives: Drug: HS-20093 (Phase Ia: Dose escalation)
HS-20093 (Phase Ib: Dose expansion)ExperimentalThe recommended dose from the dose-escalation stage and other potential doses will be further explored.
Receives: Drug: HS-20093 (Phase Ib: Dose expansion)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ⅰa (Dose-Escalation Stage): Maximum tolerated dose (MTD) for HS-20093

    To determine the MTD for further evaluation of IV administration of HS-20093 in subjects with advanced solid tumors.

    Measured: Up to day 21 from the first dose

  2. Ⅰb (Dose-Expansion Stage): Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of complete response (CR) and partial response (PR) [Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].

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

Secondary outcomes (11)

  1. Incidence and severity of adverse events (AEs)

    AE assessed by investigator exclusively related to subject's underlying disease or medical condition [graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.

    Measured: From the first dose through 90 days post end of treatment

  2. Observed maximum plasma concentration (Cmax) of HS-20093 in participants with advanced solid tumor

    Cmax will be obtained following administration of the first dose of HS-20093 during the first cycle.

    Measured: From pre-dose to 14 days after the first dose on Cycle 1

  3. Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose in participants with advanced solid tumor

    Tmax will be obtained following administration of the first dose of HS-20093 during the first cycle.

    Measured: From pre-dose to 14 days after the first dose on Cycle 1

  4. Terminal half-life (T1/2) of HS-20093 following IV dose in participants with advanced solid tumor

    Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.

    Measured: From pre-dose to 14 days after the first dose on Cycle 1

  5. Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093

    Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

    Measured: From pre-dose to 14 days after the first dose on Cycle 1

  6. Percentage of participants with antibodies to HS-20093 in serum

    Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points.

    Measured: From pre-dose to 90 days post end of treatment

  7. ORR determined by investigators according to RECIST 1.1 (dose-escalation stage)

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). 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).

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

  8. Duration of response (DOR) determined by investigators according to RECIST 1.1

    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)].

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

  9. Disease control rate (DCR) determined by investigators according to RECIST 1.1

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). 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].

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

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

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to PD or death from any cause.

    Measured: From the randomization/first dose up to PD or death, whichever came first, assessed up to 24 months

  11. Overall survival (OS) (only in dose expansion stage)

    OS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to death from any cause.

    Measured: From the randomization/first dose up to death, whichever came first, assessed up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2022
  2. Study start28 Nov 2021
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
177 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05276609
Sponsor's protocol ID
HS-20093-101
Status last verified
Feb 2023
First submitted
18 Feb 2022
Last updated
15 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-20093 (Phase Ia: Dose escalation) and HS-20093 (Phase Ib: Dose expansion) in people with Advanced Solid Tumor, run by Shanghai Hansoh Biomedical Co., Ltd at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jie Wang, PhD (13910704669, zlhuxi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ⅰa (Dose-Escalation Stage): Maximum tolerated dose (MTD) for HS-20093 (time frame: Up to day 21 from the first dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05276609.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.

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