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

Prior treatment

• Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
• Severe bleeding symptoms or bleeding tendencies within 1 month prior to the first dose of HS-20117.
• Severe arteriovenous thrombosis occurred within 3 months prior to the first dose of HS-20117
• Serious infection within 4 weeks prior to the first dose of HS-20117.

Other illness

• History of other primary malignancies.
• Severe, uncontrolled or active cardiovascular disorders.
• Severe or uncontrolled systemic diseases.
• Active infectious diseases.
• Interstitial lung disease (ILD).
• Serious neurological or mental disorders.
• History of hypersensitivity to any component of HS-20117 or similar drugs.
• Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.

Lab values

• Received or are receiving the following treatments:
  • For the phase Ib study Cohort A: Previous or current treatment with EGFR exon 20ins targeted therapy.
  • Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of HS-20117.
  • Cytotoxic chemotherapies, investigational drugs or other systematic anti-tumor therapies within 3 weeks prior to the first dose of HS-20117.
  • Antibodies within 4 weeks prior to the first dose of HS-20117.
  • 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.
  • Presence of pleural effusion/ascites requiring clinical intervention; presence of pericardial effusion.
  • Major surgery within 4 weeks prior to the first dose of HS-20117.

Other

• Untreated, or active central nervous system metastases.
• Inadequate bone marrow reserve or organ functions.

• Males or females aged 18 - 75 years (inclusive).
• 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).
• 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.
• 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.