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Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06621563•Hansoh BioMedical R&D Company

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 \&amp;gt; 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.
+3 more criteria

Locations (1)

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Key Dates

Start Date

December 14, 2024

Primary Completion Date

March 30, 2026

Completion Date

December 1, 2026

Last Updated

April 9, 2025

Enrollment

780

ESTIMATED participants

Conditions

Solid TumorsNon-Small Cell Lung CancerColorectal Cancer

Interventions

HS-20117 combined HS-20093

DRUG

HS-20117 combined Platinum-containing chemotherapy

DRUG

HS-20117 combined HS-20093 and 5-FU

DRUG

HS-20117+CAPEOX

DRUG

HS-20117+FOLFIRI

DRUG

HS-20117+mFOLFOX6

DRUG

Contacts

Xiaowei Yan

CONTACT

13061877102 yanxw@hspharm.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase Ib Trial of HS-20117 in Combination With Other Drugs in Advanced Solid Tumors

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

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