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

NCT06417008 | Recruiting Phase 2

• 1 other identifier: HS-20117-301
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; HS-20117; Epidermal Growth Factor Receptor; c-Mesenchymal-Epithelial Transition; Bispecific Antibody

Outcome Measures

Primary Outcomes (2)

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

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

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

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

  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

  Up to approximately 40 months

Secondary Outcomes (15)

• [Phase Ib and III] Overall Survival (OS)

  Approximately 60 months

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

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

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

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

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

  Up to approximately 40 months

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

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

Study Arms (3)

Phase Ib: HS-20117 and Aumolertinib

EXPERIMENTAL

Participants will receive IV infusion of HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days) at exploratory doses. Aumolertinib will be administered 110 mg orally once daily.

Drug: HS-20117; Drug: Aumolertinib

Phase III: HS-20117 and Aumolertinib

EXPERIMENTAL

Participants will receive IV infusion of HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days) at exploratory doses. Aumolertinib will be administered 110 mg orally once daily.

Drug: HS-20117; Drug: Aumolertinib

Phase III: Aumolertinib

ACTIVE COMPARATOR

Participants will receive Aumolertinib 110 mg orally once daily.

Drug: Aumolertinib

Interventions

HS-20117 DRUG

Participants will receive HS-20117 once during cycle 1 and once every 2 weeks during subsequent cycles (The duration of each treatment cycle is 28 days)

Also known as: PM1080

Phase III: HS-20117 and Aumolertinib; Phase Ib: HS-20117 and Aumolertinib

Aumolertinib DRUG

110 mg orally once daily.

Also known as: Almonertinib Mesilate Tablets, HS-10296, Almonertinib

Phase III: Aumolertinib; Phase III: HS-20117 and Aumolertinib; Phase Ib: HS-20117 and Aumolertinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Received or are receiving the following treatments:
• Previous or current treatment with MET targeted therapy or EGFR targeted antibodies or antibody-drug conjugates (ADC).
• Traditional Chinese medicine indicated for tumors, major surgery or other local therapy within washout period to the first dose of study drug.
• Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
• 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.

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

Study Sites (2)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

aumolertinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dingzhi Huang, M.D.

  Tianjin Medical University Cancer Institute and Hospital

  PRINCIPAL INVESTIGATOR

• Yun Fan, M.D.

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jialei Fu

CONTACT

+86 18652105685; fujl@hspharm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: May 16, 2024
• Study Start: May 28, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2030
• Last Updated: August 1, 2025

Record last verified: 2025-07

Locations

CN (2)