A Phase I Clinical Study of HS-20117 in Participants With Advanced Solid Tumors (NCT05940116) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Clinical Study of HS-20117 in Participants With Advanced Solid Tumors
China322 participantsStarted 2023-07-20
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
[Phase 1a] Maximum tolerated dose (MTD) of HS-20117
Timeframe: Cycle 1 (28 days)
2
[Phase 1a] Maximum applicable dose (MAD) of HS-20117
Timeframe: Cycle 1 (28 days)
3
[Phase 1b] Efficacy of HS-20117: Objective response rate (ORR)
Timeframe: From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years
✕. 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.