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NCT Number: NCT07019779

Study of CM518D1 in Patients With Advanced Solid Tumors

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

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sun Yat-sen University Cancer Center (SYSUCC)

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Ruihua Xu, Dr.

CONTACT

[email protected]

020-87343468

Ruihua Xu, Dr.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM518D1

Biological

CM518D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels.

Primary outcomes

  1. Dose Limiting Toxicity (DLT)-Phase I dose escalation

    Time frame: First cycle (21 days)

    DLT is defined as a toxicity occurring during the DLT observation period.

  2. 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.

    An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.

  3. 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.]

    An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.

  4. Preliminary efficacy-Phase I dose expansion

    Time frame: Through study completion, an average of 2 years.]

    Preliminary efficacy includes objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), and progression-free survival (PFS).

  5. Objective response rate (ORR)-Phase II

    Time frame: Through study completion, an average of 2 years.]

    ORR is defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to Response Evaluation Criteria in Solid Tumors( RECIST) v1.1.

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

028-88610620

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 13, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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