A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer

NCT06417008
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Phase
Phase 2/Phase 3
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Recruitment status
Recruiting
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Participants
1,080
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Lead sponsor
Hansoh BioMedical R&D Company
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Start date
2024-05-28
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Number of sites
2
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Summary
HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of this study is to assess the safety, efficacy, pharmacokinetics and immunogenicity of HS-20117 combined with Aumolertinib in participants with epidermal growth factor receptor (EGFR) mutation (Exon 19 deletions \[Exon 19del\] or Exon 21 L858R substitution) positive, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
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Short title
A Study of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer
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Official title
A Phase Ib/III Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Immunogenicity of HS-20117 Combined With Aumolertinib in Participants With Advanced Non-Squamous Non-Small Cell Lung Cancer
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2030-06-01
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First posted
2024-05-16
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Registry last updated
2025-08-01
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Primary completion date
2026-06-01
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Start date
2024-05-28
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Participants
1,080
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Participant count basis
Estimated
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Planned participants
1,080
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Protocol amendments
1
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Number of sites
2
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Hansoh BioMedical R&D Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06417008
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ClinicalTrials.gov ID
NCT06417008
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. [Phase Ib] Objective response rate (ORR) According to response evaluation criteria in solid tumors (RECIST) v1.1 by Investigators (INVs)

    Timeframe: From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 40 months

    ORR is defined as the percentage of participants with DOR of confirmed CR or confirmed PR per RECIST v1.1

  2. [Phase III] Progression-Free Survival (PFS) According to RECIST v1.1 by Independent Review Committee(IRC)

    Timeframe: Up to approximately 40 months

    PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1

  1. [Phase Ib and III] Overall Survival (OS)

    Timeframe: Approximately 60 months

    Overall Survival is defined as the time from the date of randomization to the date of participant's death due to any cause.

  2. [Phase Ib and III] Disease control rate (DCR) According to RECIST v1.1 by INVs

    Timeframe: From the date of first dose until the date of disease progression or withdrawal from study, approximately 40 months.

    DCR is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 6 weeks) based on Investigator's assessment per RECIST v1.1.

  3. [Phase Ib and III] Duration of response (DoR) According to RECIST v1.1 by INVs

    Timeframe: From the date of CR, PR until the date of disease progression or death, approximately 40 months.

    DoR only applies to participants whose best overall response is CR or PR based on Investigator's assessment per RECIST v1.1. The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying disease.

  4. [Phase Ib and III] Progression-Free Survival (PFS) According to RECIST v1.1 by INVs

    Timeframe: Up to approximately 40 months

    PFS is defined as the time from randomization until the date of objective disease progression or death, whichever occurred first, based on IRC using RECIST v1.1

  5. [Phase III] ORR According to RECIST v1.1 by INVs

    Timeframe: From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 40 months

    ORR is defined as the percentage of participants with BOR of CR or PR per RECIST v1.1

  6. [Phase III] ORR According to RECIST v1.1 by IRC

    Timeframe: From the date of first dose until the date of disease progression or withdrawal from study, up to approximately 40 months

    ORR is defined as the percentage of participants with BOR of CR or PR per RECIST v1.1

  7. [Phase III] DCR According to RECIST v1.1 by IRC

    Timeframe: From the date of first dose until the date of disease progression or withdrawal from study, approximately 40 months.

    DCR is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 6 weeks)

  8. [Phase III] DoR According to RECIST v1.1 by IRC

    Timeframe: From the date of CR, PR until the date of disease progression or death, approximately 40 months.

    DoR only applies to participants whose best overall response is CR or PR. The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying disease.

  9. [Phase Ib and III] Incidence and severity of treatment-emergent adverse events

    Timeframe: From the date of first dose until 90 days after the final dose. A cycle is 28 days.

    Adverse event (assessed according to NCI CTCAE v5.0) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  10. [Phase Ib and III] Immunogenicity of HS-20117

    Timeframe: Cycle 1 Day 1: predose through EOT or follow up period (90 days after the last dose).

    Immunogenicity will be measured by the number of participants that are ADA positive.

  11. [Phase Ib] PK parameters: Maximum serum concentration (Cmax) of HS-20117

    Timeframe: From the date of first dose until 30 days after the final dose. A cycle is 28 days.

    The Cmax is the maximum observed serum concentration of HS-20117

  12. [Phase Ib] PK parameters: Trough serum concentration (Ctrough) of HS-20117

    Timeframe: From the date of first dose until 30 days after the final dose. A cycle is 28 days.

    Ctrough is the observed serum concentration immediately prior to the next administration

  13. [Phase Ib] PK parameters: Area under the curve from time Zero to end of dosing interval (AUCtau) of HS-20117

    Timeframe: From the date of first dose until 30 days after the final dose. A cycle is 28 days

    The AUCtau is defined as the area under the serum concentration-time curve during a dose interval time period(tau)

  14. [Phase Ib] PK parameters: Time to reach maximum observed serum concentration (Tmax) of HS-20117

    Timeframe: From the date of first dose until 30 days after the final dose. A cycle is 28 days.

    The Tmax is defined as time to reach maximum observed serum concentration of HS-20117

  15. [Phase Ib] PK parameters: Terminal elimination half-life (t1/2) of HS-20117

    Timeframe: From the date of first dose until 30 days after the final dose. A cycle is 28 days.

    The t1/2 is defined as the time it takes for the concentration levels to fall to 50% of their value.

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  • Males or females aged 18 - 75 years (inclusive).
  • Participants with newly diagnosed histologically or cytologically confirmed, locally advanced or metastatic EGFR-sensitive mutated NSCLC (stage IIIB/IIIC/IV) that is treatment naive and not amenable to curative therapy including surgical resection or chemoradiation.
  • Agree to provide fresh or archival tumor tissue.
  • At least one target lesion per the RECIST v1.1.
  • ECOG performance status of 0-1.
  • Minimum life expectancy > 12 weeks.
  • Males or Females should be using adequate contraceptive measures throughout the study.
  • Females must not be pregnant at screening or have evidence of non-childbearing potential.
  • Have signed Informed Consent Form.

  • Received or are receiving the following treatments:

    1. Previous or current treatment with MET targeted therapy or EGFR targeted antibodies or antibody-drug conjugates (ADC).
    2. Traditional Chinese medicine indicated for tumors, major surgery or other local therapy within washout period to the first dose of study drug.
    3. Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
    4. Other investigational non-anti-tumor drugs, strong CYP3A4 inhibitors, strong inducers, drugs that are sensitive substrates of BCRP or P-gp, or drugs that prolong the QT interval within the washout period.

  • Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.

  • History of other primary malignancies.

  • Untreated, or active central nervous system metastases.

  • Inadequate bone marrow reserve or organ functions.

  • Severe, uncontrolled or active cardiovascular disorders.

  • Severe or uncontrolled systemic diseases.

  • Severe bleeding symptoms or bleeding tendencies.

  • Severe arteriovenous thrombosis occurred.

  • Serious or active infection.

  • Active infectious diseases.

  • Interstitial lung disease (ILD).

  • Serious neurological or mental disorders.

  • History of hypersensitivity to any component of HS-20117 and Aumolertinib or their similar drugs.

  • Female subjects who are pregnant, lactating, or planning to become pregnant or breastfeed during the study period or within 6 months after the last dose of the study drug.

  • Subjects with a history of severe allergic reactions or those who have experienced severe infusion reactions

  • Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.

Sources for eligibility
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  • Tianjin Medical University Cancer Institute and HospitalTianjin, ChinaRecruiting
  • Zhejiang Cancer HospitalHangzhou, ChinaRecruiting
Sources for sites
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Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)