Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06801470

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients With Advanced Solid Tumors

Led by CD (Suzhou) Biopharma Co., Ltd. · Updated on 2025-02-07

137

Participants Needed

1

Research Sites

177 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

To assess the safety, tolerability, PK and preliminary efficacy of CD-001 in patients with advanced solid tumors. and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

CONDITIONS

Official Title

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Histologically or cytologically confirmed advanced solid tumors
  • Patients lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
  • At least one measurable tumor lesion by RECIST v1.1 criteria
  • Expected survival of at least 3 months
Not Eligible

You will not qualify if you...

  • Active central nervous system or leptomeningeal metastases
  • Major organ surgery within 4 weeks before first dose or expected major surgery during study
  • Severe unhealed wounds, trauma, or ulcers
  • Previous major organ, bone marrow, or allogeneic stem-cell transplant
  • Active or chronic autoimmune disease requiring systemic therapy within past 2 years or ongoing systemic therapy for autoimmune or inflammatory disease
  • Anti-tumor therapy within 4 weeks or 5 drug half-lives before first dose
  • Any serious or uncontrollable disease or associated risk as judged by investigator
  • History of Grade 3 or higher immune-related adverse events or permanent drug discontinuation due to such events
  • Pulmonary embolism within 6 months prior to first dose or presence of interstitial pneumonia at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Tianjin Medical University Cancer Institute&Hospital

Tianjin, China

Actively Recruiting

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Research Team

D

Daqing Tang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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