NCT06621563 Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors
| NCT ID | NCT06621563 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hansoh BioMedical R&D Company |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 780 participants |
| Start Date | 2024-12-14 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 780 participants in total. It began in 2024-12-14 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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, efficacy, PK profile and immunogenicity of HS-20117 in combination with other drugs in advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Received or are receiving the following treatments: 1. Any anticancer therapy targeting MET, including TKIs, antibodies or antibody-drug conjugates. 2. Monoclonalor bispecific antibodies targeting EGFR. 3. Systemic anti-cancer treatment (Cytotoxicities and anti-cancer Traditional Chinese medicine or TKIs) within 2 weeks prior to the first dose of HS-20117. 4. Investigational anti-cancer drugs or antibodies or ADCs 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. * Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy. * Presence of uncured secondary primary malignancies. * Untreated, or active central nervous system metastases. * Severe, uncontrolled or active cardiovascular disorders. * Serious infection within 4 weeks prior to the first dose of HS-20117.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06621563 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06621563 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06621563 currently recruiting?
Yes, NCT06621563 is actively recruiting participants. Contact the research team at yanxw@hspharm.com for enrollment information.
Where is the NCT06621563 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT06621563 clinical trial?
NCT06621563 is sponsored by Hansoh BioMedical R&D Company. The trial plans to enroll 780 participants.