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Recruiting NCT07019779

Study of CM518D1 in Patients With Advanced Solid Tumors

Phase I / Phase II Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CM518D1, CM518D1, CM518D1.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Open-Label, Phase I/II Clinical Study to Evaluate CM518D1 in the Treatment of Patients With Advanced Solid Tumors

Overview

This is an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CM518D1 in patients with advanced solid tumors.

Interventions

  • Biological CM518D1
    CM518D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels.
  • Biological CM518D1
    CM518D1 will be administered intravenously once every 3 weeks (Q3W) in one or more potential recommended phase 2 dose(RP2D).
  • Biological CM518D1
    CM518D1 will be administered intravenously once every 3 weeks (Q3W) in different types of solid tumor cohorts.

Primary outcome measures

  • Dose Limiting Toxicity (DLT)-Phase I dose escalation [Time frame: First cycle (21 days)]
  • Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose escalation [Time frame: Through study completion, an average of 2 years.]
  • Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose expansion [Time frame: Through study completion, an average of 2 years.]]
  • Preliminary efficacy-Phase I dose expansion [Time frame: Through study completion, an average of 2 years.]]
  • Objective response rate (ORR)-Phase II [Time frame: Through study completion, an average of 2 years.]]

Eligibility criteria

Inclusion criteria

  • 1\. Male or female ≥ 18 and ≤75 years of age.
  • 2\. Subjects with histologically or cytologically confirmed advanced solid tumors.
  • 3\. At least one measurable lesion according to RECIST v1.1.
  • 4\. Expected survival time ≥ 3 months as judged by the Investigator.

Exclusion criteria

  • 1\. Subjects who have received any chemotherapy or any drug therapy for antitumor treatment including monoclonal antibodies, targeted therapy, radioimmunoconjugates, or Antibody-Drug Conjugates(ADCs), or any investigational product therapy for anti-tumor therapy within 28 days prior to the first dose or within 5 half-lives (whichever is shorter).
  • 2\. Subjects who have received major surgery within 28 days prior to the first dose.
  • 3\. Subjects who have received radiotherapy within 21 days prior to the first dose.
  • 4\. Subjects who have received systemic glucocorticoid therapy (more than 10 mg of prednisone or equivalent daily) or other forms of immunosuppressive therapy within 7 days prior to the first dose.
  • 5\. Subjects who have received any CDH17-targeted therapy.
  • 6\. History of other malignancies within 5 years prior to the first dose, excluding cured basal or squamous cell carcinoma of skin, carcinoma cervix in situ, or breast ductal carcinoma in situ.
  • 7\. Hypersensitivity to the investigational drug or its excipients.
  • 8\. Pregnant or lactating female patients.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen University Cancer Center (SYSUCC) — Guangzhou

Identifiers

NCT: NCT07019779 · CM518D1-030101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗