A Phase I Clinical Study of HS-20117 in Participants With Advanced Solid Tumors

Trial Title: A Phase I Clinical Study of HS-20117 in Participants With Advanced Solid Tumors

NCT ID: NCT05940116

Condition: Non-Small Cell Lung Cancer
Solid Tumor

Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung

Conditions: Keywords:
Non-Small Cell Lung Cancer
Solid Tumor
HS-20117
Epidermal Growth Factor Receptor
c-Mesenchymal-Epithelial Transition
Bispecific Antibody
EGFR exon 20 insertion

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: HS-20117
Description: Phase Ia: patients will receive HS-20117 starting at 400 mg, and subsequent cohorts will test escalating doses, if tolerated, until a maximum tolerated dose (MTD) or maximum applicable dose (MAD) is defined. Phase Ib: patients will receive HS-20117 at MED or MAD
Arm group label: HS-20117

Other name: PM1080

Summary: HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of HS-20117 as a monotherapy for participants with advanced solid tumors.

Detailed description: This is a multicenter, open-label, Phase I clinical study of HS-20117 to evaluate the safety, tolerability, PK, immunogenicity and efficacy in participants with advanced solid tumors. The study consists of phase Ia (dose escalation) and phase Ib (dose expansion). The dose-escalation study will be performed to evaluate the safety, tolerability, PK profile, immunogenicity, and efficacy of HS-20117 in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations. The subsequent dose-expansion study will be performed to evaluate the efficacy of HS-20117 in participants with locally advanced or metastatic NSCLC who have progressed after prior platinum-based chemotherapy or are intolerant to platinum-based chemotherapy with EGFR exon 20 insertion mutations, and to explore the efficacy of HS-20117 in participants with other advanced solid tumors.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Males or females aged 18 - 75 years (inclusive). 2. For the phase Ia study: Participants with locally advanced or metastatic NSCLC (stage IIIB/IIIC/IV) with EGFR-activating mutations who have progressed after or are intolerant to or not available to standard of care (SoC). 3. For the phase Ib study: Cohort A: Participants with locally advanced or metastatic NSCLC (stage IIIB/IIIC/IV) with EGFR exon 20ins mutations who have progressed after prior platinum-based chemotherapy or are intolerant to platinum-based chemotherapy. Cohort B: Participants with other advanced solid tumors who have progressed after prior SoC or are intolerant to SoC. 4. Agree to provide fresh or archival tumor tissue. 5. At least one target lesion per the RECIST v1.1. 6. ECOG performance status of 0-1. 7. Minimum life expectancy > 12 weeks. 8. Males or Females should be using adequate contraceptive measures throughout the study. 9. Females must not be pregnant at screening or have evidence of non-childbearing potential. 10. Have signed Informed Consent Form. Exclusion Criteria: 1. Received or are receiving the following treatments: 1. For the phase Ib study Cohort A: Previous or current treatment with EGFR exon 20ins targeted therapy. 2. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of HS-20117. 3. Cytotoxic chemotherapies, investigational drugs or other systematic anti-tumor therapies within 3 weeks prior to the first dose of HS-20117. 4. Antibodies within 4 weeks prior to the first dose of HS-20117. 5. Local radiotherapy within 2 weeks prior to the first dose of HS-20117, more than 30% of bone marrow irradiation or large-area radiotherapy within 4 weeks before the first dose of HS-20117. 6. Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion. 7. Major surgery within 4 weeks prior to the first dose of HS-20117. 2. Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy. 3. History of other primary malignancies. 4. Untreated, or active central nervous system metastases. 5. Inadequate bone marrow reserve or organ functions. 6. Severe, uncontrolled or active cardiovascular disorders. 7. Severe or uncontrolled systemic diseases. 8. Severe bleeding symptoms or bleeding tendencies within 1 month prior to the first dose of HS-20117. 9. Severe arteriovenous thrombosis occurred within 3 months prior to the first dose of HS-20117 10. Serious infection within 4 weeks prior to the first dose of HS-20117. 11. Active infectious diseases. 12. Interstitial lung disease (ILD). 13. Serious neurological or mental disorders. 14. History of hypersensitivity to any component of HS-20117 or similar drugs. 15. Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Tianjin Medical University Cancer Institute and Hospital

Address:
City: Tianjin
Zip: 300181
Country: China

Contact:
Last name: Lin Jiang

Phone: +86 022-23340123

Phone ext: 6417
Email: jianglinchn@163.com

Investigator:
Last name: Dingzhi Huang, Dr.
Email: Principal Investigator

Start date: July 20, 2023

Completion date: July 30, 2027

Lead sponsor:
Agency: Hansoh BioMedical R&D Company
Agency class: Industry

Source: Hansoh BioMedical R&D Company

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05940116