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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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.