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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.
This is a multicenter, open-label, Phase Ib clinical trial of HS-20117 combination therapies to evaluate the safety, tolerability, efficacy, PK profile and immunogenicity in participants with advanced solid tumors. The study includes a dose escalation part and a dose expansion part. The dose-escalation study will be performed to evaluate the safety, tolerability, PK profile, immunogenicity, and efficacy of HS-20117 combination therapies in participants with advanced solid tumor. The subsequent dose-expansion study will be performed to evaluate the efficacy of HS-20117 combination therapies in participants with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations or EGFR classical mutations, and RAS/BRAF V600E wild type CRC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1a | Experimental | NSCLC |
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| Cohort 2a | Experimental | NSCLC |
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| Cohort 3a | Experimental | CRC |
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| Cohort 4a | Experimental | CRC |
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| Cohort 5a | Experimental | CRC |
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| Cohort 6a | Experimental | CRC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20117 combined HS-20093 | Drug | HS-20117 + HS-20093 |
| |
| HS-20117 combined Platinum-containing chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events | 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. | rom the date of first dose to 90 days after the final dose. |
| 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. | 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. | From the date of first dose to day 21. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of HS-20117: Objective response rate (ORR) | ORR is defined as the percentage of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1 | From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years |
| Efficacy of HS-20117: disease control rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
Received or are receiving the following treatments:
Presence of Grade ā„ 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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaowei Yan | Contact | 13061877102 | yanxw@hspharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital | Recruiting | Tianjin | China |
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| Drug |
HS-20117 + cisplatin/carboplatin + pemetrexed |
|
| HS-20117 combined HS-20093 and 5-FU | Drug | HS-20117 + HS-20093 + 5-FU |
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| HS-20117+CAPEOX | Drug | CAPOEX: Oxaliplatin+Capecitabine |
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| HS-20117+FOLFIRI | Drug | FOLFIRI=Irinotecan+Leucovorin Calcium+5-FU |
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| HS-20117+mFOLFOX6 | Drug | mFOLFOX6=Oxaliplatin+Leucovorin Calcium+5-FU |
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DCR is deļ¬ned 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. |
| From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years |
| Efficacy of HS-20117: duration of response (DoR) | 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. | From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years |
| Efficacy of HS-20117: progression free survival (PFS) | 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. | From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years |
| Efficacy of HS-20117: overall survival (OS) | 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. | From the date of first dose to the date of disease progression or withdrawal from study, approximately 2 years |
| PK parameters: Trough serum concentration (Ctrough) of HS-20117 and HS-20093 | Ctrough is the observed serum concentration immediately prior to the next administration. | From the date of first dose to 90 days after the final dose. |
| PK parameters: Time to reach maximum observed serum concentration (Tmax) of HS-20117 | The Tmax is defined as time to reach maximum observed serum concentration of HS-20117. | From the date of first dose to 90 days after the final dose. |
| PK parameters: Area under the curve from time Zero to end of dosing interval (AUCtau) of HS-20117 | The AUCtau is defined as the area under the serum concentration-time curve during a dose interval time period (tau). | From the date of first dose to 90 days after the final dose. |
| PK parameters: Maximum serum concentration (Cmax) of HS-20117 and HS-20093. | The Cmax is the maximum observed serum concentration of HS-20117, HS-20093. | From the date of first dose to 90 days after the final dose. |
| Immunogenicity of HS-20117 | Immunogenicity will be measured by the number of participants that are ADA positive. | From the date of first dose to 90 days after the final dose. |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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