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

ConditionLung Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • HS-10504

    Drug

    HS-10504 administered orally every day

  • SHR-A2009

    Drug

    SHR-A2009 administered intravenously

  • HS-20122

    Drug

    HS-20122 administered intravenously

  • HS-20117

    Drug

    HS-20117 administered intravenously

  • SHR-1826

    Drug

    SHR-1826 administered intravenously

  • SHR-A2102

    Drug

    SHR-A2102 administered intravenously

Treatment groups

400 Participants
are divided into 5 treatment groups
Group A: Cohort 1aExperimental treatment 2 interventions
Group B: Cohort 1bExperimental treatment 2 interventions
Group C: Cohort 1cExperimental treatment 2 interventions
Group D: Cohort 1dExperimental treatment 2 interventions
Group E: Cohort 2Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Through the full duration of this trial, approximately 2 years
2

ORR

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

Time frame
Through the full duration of this trial, approximately 2 years
3

TEAE

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

Time frame
Through the full duration of this trial, approximately 2 years
4

TRAE

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

Time frame
Through the full duration of this trial, approximately 2 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: