NCT06826040

Brief Summary

This is a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB445 for injection in patients with advanced solid tumors.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
126

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 Progress45%
Feb 2025Dec 2027

First Submitted

Initial submission to the registry

January 19, 2025

Completed
17 days until next milestone

Study Start

First participant enrolled

February 5, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 13, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.9 years

First QC Date

January 19, 2025

Last Update Submit

May 5, 2026

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • Number of subjects achieving Dose-limiting toxicity (DLT)

    DLT is defined as an adverse event (AE) that meets protocol defined DLT criteria during cycle 1 and is at least possibly related to study drug.

    From date of initial dose until up to 21 days for treatment

Secondary Outcomes (4)

  • Objective Response Rate (ORR)

    Up to 3 years

  • Progression Free Survival (PFS)

    Up to 3 years

  • Duration of Response (DOR)

    Up to 3 years

  • Overall Survival (OS)

    Up to 3 years

Study Arms (1)

Dose Escalation Phase

EXPERIMENTAL

Subject will be dosed with SKB445 for injection q3w

Drug: SKB445 for injection

Interventions

SKB445 for injectionDRUG

SKB445 for injection is administered every 3 weeks (q3w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.

Dose Escalation Phase

Eligibility Criteria

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

You may qualify if:

  • At the time of signing the ICF: age between 18 -75 years, male or female.
  • subjects with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed/are intolerant/ineligible to or do not have standard therapy, and have at least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
  • Expected survival ≥ 3 months.
  • Subjects with adequate organ and bone marrow function confirmed by laboratory results
  • Subjects of childbearing potential (male or female) must use effective medical contraception during the study
  • Ability to understand and willingness to sign ICF, and will be able to comply with the protocol-specified visits and relevant procedures.

You may not qualify if:

  • Has received anti-tumor therapy, including chemotherapy, targeted therapy, tumor immunotherapy, and traditional Chinese medicinal products with anti-tumor indications, within 4 weeks prior to the first dose or within 5 half-lives of known drugs (whichever is shorter).
  • Has had major surgery within 4 weeks prior to the first dose.
  • Has known history of allergy to any component of SKB445 or SKB445.
  • Has a known previous or concurrent other malignancies within 3 years prior to first dose.
  • Presence of active central nervous system (CNS) metastases.
  • Has uncontrolled or severe cardiovascular disease.
  • Has uncontrolled systemic diseases.
  • Has human immunodeficiency virus (HIV) infection; has any active viral hepatitis.
  • Subjects with a known history of psychiatric illness or drug abuse that would preclude the subject from complying with the study.
  • Has prior autologous/allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
  • Has any other conditions such as medical history, treatment and laboratory abnormalities that may confound the study results, interfere with the subject's compliance, or impair the subject's interests, as assessed by the investigator or the sponsor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Central Study Contacts

Xin Li

CONTACT

086-010-58302512lixin@kelun.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

January 19, 2025

First Posted

February 13, 2025

Study Start

February 5, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

May 8, 2026

Record last verified: 2026-05

Locations

CN(1)