NCT07697586

Brief Summary

This is an open-label, multi-center, Phase II clinical study to evaluate the safety, tolerability, and efficacy of SKB264 in combination with SKB118 in participants with NSCLC. The study includes a dose escalation phase and an expansion phase.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for phase_2

Timeline
37mo left

Started Aug 2026

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
not yet 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

First Submitted

Initial submission to the registry

July 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

July 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

July 3, 2026

Last Update Submit

July 10, 2026

Conditions

NSCLC

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment

    adverse events (AEs) and serious adverse events (SAEs), dose-limiting toxicities (DLTs), clinically significant abnormal laboratory results, etc.

    From enrollment to the end of treatment at 24 months

  • ORR(objective response rate)

    ORR as assessed by the investigator based on RECIST v1.1

    From enrollment to the end of treatment at 24 months

Secondary Outcomes (4)

  • DCR(Disease control rate )

    From enrollment to the end of treatment at 24 months

  • DOR(duration of response )

    From enrollment to the end of treatment at 24 months

  • PFS(progression-free survival)

    From enrollment to the end of treatment at 24 months

  • OS (overall survival)

    From enrollment to the end of treatment at 24 months

Study Arms (1)

SKB264 in combination with SKB118

EXPERIMENTAL

SKB264 at 4 mg/kg combined with SKB118 at 3 mg/kg, 10 mg/kg, 20 mg/kg, or other dose levels

Drug: SKB264+SKB118

Interventions

SKB264+SKB118DRUG

Administered by intravenous infusion on Day 1 and Day 15 of each 28-day cycle.

SKB264 in combination with SKB118

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed locally advanced or metastatic NSCLC
  • Without epidermal growth factor receptor (EGFR) sensitizing mutation, and anaplastic lymphoma kinase (ALK) fusion gene.
  • Provide a tumor tissue sample.
  • At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
  • ECOG performance status of 0 or 1.
  • Life expectancy ≥ 12 weeks.
  • Adequate bone marrow, liver, kidney, and coagulation function.
  • Male and female participants must agree to use highly effective methods of contraception during the specified period of the study.

You may not qualify if:

  • Histologically or cytologically confirmed co-existing small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components.
  • Participants with known metastases to meninges, brainstem metastases, metastases to spinal cord and/or compression, or active metastases to central nervous system (CNS).
  • Uncontrolled systemic disease as judged by the investigator.
  • Presence of uncontrolled, clinically symptomatic, or requiring repeated drainage pleural effusion, pericardial effusion, or ascites.
  • Presence of other moderate to severe lung disorders.
  • History of haemorrhagic diathesis or coagulopathy and/or clinically significant bleeding symptoms or risks.
  • Previous or co-existing gastrointestinal diseases, surgery, and wound healing complications.
  • Active hepatitis b or hepatitis c or co-infection with HBV and HCV.
  • Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation.
  • Known hypersensitivity to the study drug or any of its components.
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jilin Cancer Hospital

Jilin City, China

Location

Shanghai East Hospital, Tongji University

Shanghai, China

Location

Central Study Contacts

Yan Qing Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

CONTACT

028-67255480qingyan@kelun.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 13, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2029

Last Updated

July 13, 2026

Record last verified: 2026-04

Locations

CN(2)