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Extensive Stage Small Cell Lung Cancer (ES-SCLC)Phase 2NCT06052423

ARTEMIS-007: HS-20093 in Patients With Extensive Stage Small Cell Lung Cancer

A Phase 2 study testing HS-20093 in people with Extensive Stage Small Cell Lung Cancer (ES-SCLC), run by Hansoh BioMedical R&D Company.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a phase 2,open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with small cell lung cancer(SCLC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
HS-20093
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
30 Nov 2024to 30 Jun 2027
Phase
Phase 2
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.
  • Pathologically diagnosed as ES-SCLC; no prior systemic therapy for ES-SCLC.
  • At least one measurable lesion according to RECIST 1.1.
  • Agree to provide fresh or archival tumor tissue and peripheral blood samples.
  • ECOG PS of 0~1.
  • Life expectancy >= 12 weeks.
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  • 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

  • Treatment with any of the following:
  • Previous or current treatment with B7-H3 targeted therapy
  • 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.
  • Pleural or peritoneal effusion or pericardial effusion requiring clinical intervention.
  • Major surgery within 4 weeks prior to the first dose of HS-20093.
  • Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.
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  • Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study.
  • 2. Spinal cord compression or brain metastases. 3. CNS metastases with symptomatic or active progression. 4. Patients with tumor invasion of surrounding vital organs and blood vessels, at risk of esophagotracheal or esophagopleural fistula.
  • 5. Any unresolved toxicities from prior therapy greater than Grade 2 according to CTCAE 5.0.
  • 6. History of other primary malignancies. 7. Inadequate bone marrow reserve or organ dysfunction 8. Evidence of cardiovascular risk. 9. Severe, uncontrolled or active cardiovascular diseases. 10. Diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug, or the glycosylated hemoglobin value ≥ 7.5% in the screening period.
  • 11. Severe or poorly controlled hypertension. 12. Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 month prior to the first dose of HS-20093 13. Serious arteriovenous thrombosis events occurred within 3 months before the first dose.
  • 14. Severe infections occurred within 4 weeks before the first dose. 15. Patients who have received continuous glucocorticoid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment, or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation.
  • 16. The presence of active infectious diseases has been known before the first dose such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.
  • 17. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
  • 18. Other moderate or severe lung diseases. 19. Previous history of serious neurological or mental disorders. 20. Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
  • 21. Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose of HS-20093 22. History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.
  • 23. Hypersensitivity to any ingredient of HS-20093. 24. Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator 25. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments

About this study

Official title: ARTEMIS-007: A Phase 2 Study to Evaluate Efficacy and Safety of HS-20093 in Patients With Extensive Stage Small Cell Lung Cancer

This is a phase 2,open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with small cell lung cancer(SCLC).

Read the detailed description

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

Being tested
HS-20093
Keywords
Extensive Stage Small Cell Lung Cancer, 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-20093Drug

    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.

Study groups in NCT06052423
Study groupRoleWhat they receive
HS-20093ExperimentalAll subjects will receive HS-20093 at 10mg/kg
Receives: Drug: HS-20093

What is being measured

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

  1. Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on RECIST version 1.1[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)]

    Measured: From the first dose up to disease progression or withdrawal from study, which ever came first, assessed up to 18 months

Secondary outcomes (10)

  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

    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 (each cycle is 21 days)

  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 (each cycle is 21 days)

  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 (each cycle is 21 days)

  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 (each cycle is 21 days)

  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. 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. 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 disease progression or withdrawal from study, whichever came first, assessed up to 18 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 progressive disease (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 disease progression or withdrawal from study, whichever came first, assessed up to 18 months

  9. 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. PFS was defined as the time from first dose or random assignment (if any) to PD or death from any cause

    Measured: From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed up to 18 months

  10. Overall survival (OS)

    OS was defined as the time from the first dose or random assignment (if any) to death from any cause

    Measured: From the first dose or random assignment up to death or withdrawal from study, whichever came first, assessed up to 18 months

Timeline

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

  1. First posted25 Sep 2023
  2. Study start30 Nov 2024 (estimated)
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Why it stopped: Research and development strategy adjustment.

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Arm
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06052423
Sponsor's protocol ID
HS-20093-206
Status last verified
Mar 2024
First submitted
18 Sep 2023
Last updated
4 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HS-20093 in people with Extensive Stage Small Cell Lung Cancer (ES-SCLC), run by Hansoh BioMedical R&D Company.

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 9 inclusion and 17 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: withdrawn, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (time frame: From the first dose up to disease progression or withdrawal from study, which ever came first, assessed up to 18 months). 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 NCT06052423.

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 4 Mar 2024.

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