A Phase Ib Study of HS-10504 Combined Therapy in NSCLC

NCT07414953 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HS-10504-103
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-10504 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (5)

• RP2D for Combination

  To evaluate the potent and tolerated of combination(s) and dosage(s) of HS-10504 based therapy in subjects with EGFR mutation-positive locally advanced or metastatic NSCLC who have experienced disease progression on or after prior treatment, which suitable for a Phase II trial

  Through the full duration of this trial, approximately 2 years

• ORR

  Investigator evaluated overall response rate, to evaluate the efficacy of each combination

  Through the full duration of this trial, approximately 2 years

• TEAE

  incidence of Investigator evaluated Treatment Emerged Adverse Events, graded per CTCAE V5.0

  Through the full duration of this trial, approximately 2 years

• TRAE

  incidence of Investigator evaluated Treatment Related Adverse Events, graded per CTCAE V5.0

  Through the full duration of this trial, approximately 2 years

• SAE

  incidence of Investigator evaluated Severe Adverse Events, graded per CTCAE V5.0

  Through the full duration of this trial, approximately 2 years

Study Arms (5)

Cohort 1a

EXPERIMENTAL

Drug: HS-10504; Drug: SHR-A2102

Cohort 1b

EXPERIMENTAL

Drug: HS-10504; Drug: SHR-A2009

Cohort 1c

EXPERIMENTAL

Drug: HS-10504; Drug: HS-20122

Cohort 1d

EXPERIMENTAL

Drug: HS-10504; Drug: HS-20117

Cohort 2

EXPERIMENTAL

Drug: HS-10504; Drug: SHR-1826

Interventions

HS-10504 DRUG

HS-10504 administered orally every day

Cohort 1a; Cohort 1b; Cohort 1c; Cohort 1d; Cohort 2

SHR-A2009 DRUG

SHR-A2009 administered intravenously

Cohort 1b

HS-20122 DRUG

HS-20122 administered intravenously

Cohort 1c

HS-20117 DRUG

HS-20117 administered intravenously

Cohort 1d

SHR-1826 DRUG

SHR-1826 administered intravenously

Cohort 2

SHR-A2102 DRUG

SHR-A2102 administered intravenously

Cohort 1a

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort1:participants with EGFR mutation advanced stage NSCLC，disease progression on or after prior treatment；
• Cohort2:participants with MET position advanced stage NSCLC，disease progression on or after prior treatment；
• With at least 1 target lesion according to RECIST 1.1.
• Appropriate organ function
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 and no deterioration within 2 weeks prior to the first dose.
• Minimum expected survival longer than 12 weeks
• Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent form (ICF) through 6 months after the last dose; male subjects are willing to use barrier contraception (i.e., condom) from signing the ICF through 6 months after the last dose.
• Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign written informed consent form.

You may not qualify if:

• Insufficient wash out duration of prior systemic anticancer therapy
• Local radiotherapy within 2 weeks prior to first dose of investigational drug
• Pleural/abdominal effusion requires clinical intervention
• Major surgery within 4 weeks prior to first dose of investigational drug
• History of drugs may prolong QT interval
• Have any grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior anti-tumor therapy (except alopecia and residual neurotoxicity).
• Presence of brain metastasis or carcinomatous meningtitis
• History of other primary malignancies
• Significant, uncontrolled, or active cardiovascular diseases
• Severe or poorly controlled diabetes
• Extremely obesity or emaciation
• Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose
• Severe arteriovenous thrombotic events (e.g., deep venous thrombosis, pulmonary embolism) within 3 months prior to the first dose
• Severe infection within 4 weeks
• History of systemic glucocorticoids over 28 days prior to first dose of investigational drug

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: March 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: February 17, 2026

Record last verified: 2026-02