NCT06621563RecruitingPhase 1
Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors
Safety, Tolerability, Efficacy, Pharmacokinetics Profile and Immunogenicity of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors, a Phase Ib Clinical Trial
Source: ClinicalTrials.gov · Last updated 9 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
HS-20117 is a fully-human EGFR-MET immunoglobulin G1(IgG1)-like bispecific antibody. The purpose of study is to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 780 (estimated)
- First submitted
- 29 Sept 2024
- Start date
- 14 Dec 2024
- Primary completion date
- 30 Mar 2026
- Lead sponsor
- Hansoh BioMedical R&D Company
- Diseases
- Lung cancer, Colorectal cancer
- NCT number
- NCT06621563
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 780
- From 14 Dec 2024 to the primary completion date, 30 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
- Serious infection within 4 weeks prior to the first dose of HS-20117.
Other illness
- Presence of uncured secondary primary malignancies.
- Severe, uncontrolled or active cardiovascular disorders.
Lab values
- Received or are receiving the following treatments:
- Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-drug conjugates.
- Monoclonalor bispecific antibodies targeting EGFR.
- Systemic anti-cancer treatment (Cytotoxicities and anti-cancer Traditional Chinese medicine or TKIs) within 2 weeks prior to the first dose of HS-20117.
- Investigational anti-cancer drugs or antibodies or ADCs 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.
Who the study is looking for
- Males or females aged 18 - 75 years (inclusive).
- Histologically confirmed unresectable, recurrent or metastatic solid tumors.
- 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.
- Signed Informed Consent Form.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.