> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-ib-trial-of-hs-20117-in-combination-with-other-drugs-8ed9476e-9edf-4544-b110-eefa69275de3 > Record changed: 2026-10-13 # Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors NCT06621563 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) Participants 780 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) Lead sponsor Hansoh BioMedical R&D Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) Start date 2024-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Acronym** HS-20117 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Short title** Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Official title** 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](https://clinicaltrials.gov/study/NCT06621563) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) ## Dates **Completion date** 2026-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **First posted** 2024-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Registry last updated** 2025-04-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Primary completion date** 2026-03-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Start date** 2024-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) ## Size and sites **Participants** 780 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Planned participants** 780 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Lead sponsor** Hansoh BioMedical R&D Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) ## Identifiers **Registry ID** NCT06621563 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **ClinicalTrials.gov ID** NCT06621563 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) ## Outcomes ### Primary outcomes 1. Incidence and severity of treatment-emergent adverse events Timeframe: rom the date of first dose to 90 days after the final dose. Adverse event (assessed according to NCI CTCAE v5.0) is defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 2. Tolerability of HS-20117 combination therapy: incidence of DLT events, maximum tolerated dose (MTD) or maximum applicable dose (MAD) of HS-20117 in combination therapies. Timeframe: From the date of first dose to day 21. MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT. MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored. ### Secondary outcomes 1. Efficacy of HS-20117: Objective response rate (ORR) Timeframe: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years ORR is defined as the percentage of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1 2. Efficacy of HS-20117: disease control rate (DCR) Timeframe: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years DCR is defined as the percentage of patients who have a best overall response (confirmed CR, PR, or stable disease for at least 6 weeks) per RECIST v1.1. 3. Efficacy of HS-20117: duration of response (DoR) Timeframe: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years DoR only applies to participants whose best overall response is CR or PR based on assessment per RECIST v1.1\. The start date is the date of first documented response of CR or PR (i.e. the start date of observed response, not the date when response was confirmed), and the end date is defined as the date of the first documented progression or death due to underlying disease. 4. Efficacy of HS-20117: progression free survival (PFS) Timeframe: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years PFS is defined as the time from the date of randomization or first dose (if randomization is not needed) to the date of the first documented progression or death due to any cause. PFS will be assessed per RECIST v1.1. 5. Efficacy of HS-20117: overall survival (OS) Timeframe: From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years OS is defined as the time from the date of randomization or first dose (if randomization is not needed) to the date of death due to any cause. For each participant who is not known to have died as of the cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive. 6. PK parameters: Trough serum concentration (Ctrough) of HS-20117 and HS-20093 Timeframe: From the date of first dose to 90 days after the final dose. Ctrough is the observed serum concentration immediately prior to the next administration. 7. PK parameters: Time to reach maximum observed serum concentration (Tmax) of HS-20117 Timeframe: From the date of first dose to 90 days after the final dose. The Tmax is defined as time to reach maximum observed serum concentration of HS-20117. 8. PK parameters: Area under the curve from time Zero to end of dosing interval (AUCtau) of HS-20117 Timeframe: From the date of first dose to 90 days after the final dose. The AUCtau is defined as the area under the serum concentration-time curve during a dose interval time period (tau). 9. PK parameters: Maximum serum concentration (Cmax) of HS-20117 and HS-20093. Timeframe: From the date of first dose to 90 days after the final dose. The Cmax is the maximum observed serum concentration of HS-20117, HS-20093. 10. Immunogenicity of HS-20117 Timeframe: From the date of first dose to 90 days after the final dose. Immunogenicity will be measured by the number of participants that are ADA positive. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) ## Sites - Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06621563) ## Related records ### Drugs (3) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Mescaline](https://trialight.com/data/asset/mescaline-bc193405-4b6d-435d-acbf-612e7292826a.md) - [Platinum](https://trialight.com/data/asset/platinum-418ce0fe-dd28-40a8-8225-5d12ccc291d1.md) ### Lead sponsors (1) - [Hansoh BioMedical R&D Company](https://trialight.com/data/company/hansoh-biomedical-r-d-company-e6d6662a-6212-498b-9d6d-765fcd3d7749.md) ### Conditions (3) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) ### Targets (1) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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