NCT06754930

Brief Summary

This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_1

Timeline
19mo left

Started Feb 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Feb 2025Dec 2027

First Submitted

Initial submission to the registry

December 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 1, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

February 18, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

2.8 years

First QC Date

December 24, 2024

Last Update Submit

April 16, 2025

Conditions

Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (3)

  • Recommended phase II dose (RP2D)

    Screening up to study completion, an average of 1 year.

  • Adverse events (AEs)

    Screening up to study completion, an average of 1 year.

  • Objective response rate (ORR)

    Screening up to study completion, an average of 1 year.

Secondary Outcomes (7)

  • Disease control rate (DCR)

    Screening up to study completion, an average of 1 year.

  • Duration of response (DoR)

    Screening up to study completion, an average of 1 year.

  • Progression-free survival (PFS)

    Screening up to study completion, an average of 1 year.

  • Overall survival (OS)

    Screening up to study completion, an average of 1 year.

  • Drug resistant antibody (ADA) to SHR-1826

    Screening up to study completion, an average of 1 year.

  • +2 more secondary outcomes

Study Arms (1)

Experimental group

EXPERIMENTAL
Drug: SHR-1826Drug: SHR-1316Drug: SHR-9839Drug: SHR-8068Drug: Ametinib mesylateDrug: BP-102Drug: Carboplatin

Interventions

SHR-1826DRUG

SHR-1826 for injection.

Experimental group
SHR-1316DRUG

SHR-1316 for injection.

Experimental group
SHR-9839DRUG

SHR-9839 for injection.

Experimental group
SHR-8068DRUG

SHR-8068 for injection.

Experimental group
Ametinib mesylateDRUG

Ametinib mesylate.

Experimental group
BP-102DRUG

BP-102 for injection.

Experimental group
CarboplatinDRUG

Carboplatin for injection.

Experimental group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Voluntary participation and written informed consent.
  • years older, no gender limitation.
  • Eastern Cooperative Oncology Group (ECOG) score: 0-1.
  • With a life expectancy ≥ 3 months.
  • Pathologically diagnosed NSCLC.
  • Be able to provide fresh or archived tumour tissue.
  • At least one measurable lesion according to RECIST v1.1.
  • Adequate organ function.
  • Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.

You may not qualify if:

  • Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
  • Previous or co-existing malignancies.
  • Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded.
  • Uncontrollable tumor-related pain.
  • Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing.
  • Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment.
  • Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy.
  • With poorly controlled or severe cardiovascular disease.
  • Active hepatitis B and hepatitis C.
  • Patients with a history of immunodeficiency.
  • Severe infection 30 days before the first dose.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic Chemicals

Central Study Contacts

Yijun Jia

CONTACT

+86-18801784695yijun.jia@hengrui.com

Tingting Lei

CONTACT

+86-18610051325Tingting.lei.tl6@hengrui.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2024

First Posted

January 1, 2025

Study Start

February 18, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 17, 2025

Record last verified: 2025-04

Locations

CN(1)