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A Study to Evaluate the Safety, Tolerability, PK, PD, and Preliminary Efficacy of CS01 in Patients With Locally Advanced or Metastatic Solid Tumors

NCT07461181 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-10

No results posted yet for this study

Summary

This is an investigator-initiated clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of CS01 in patients with locally advanced or metastatic solid tumors.

Conditions

  • Locally Advanced or Metastatic Solid Tumors

Interventions

BIOLOGICAL

CS01 (an anti-OX40 antibody)

OX40 is a costimulatory receptor expressed on activated CD4⁺ and CD8⁺ T cells that enhances T-cell proliferation and survival within the tumor microenvironment. CS01 is a novel agonistic anti-OX40 IgG monoclonal antibody optimized with an intermediate binding-affinity Fab and a constant domain enabling enhanced Fcγ receptor engagement.

Sponsors & Collaborators

  • Zhongshan Constimulus Bio Co., Ltd

    collaborator UNKNOWN

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07461181 on ClinicalTrials.gov