Study of CM518D1 in Patients With Advanced Solid Tumors
Recruiting now · Phase 1/Phase 2
Conditions studied: Advanced Solid Tumors
In brief
This is an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CM518D1 in patients with advanced solid tumors.
Key facts
- Study ID
- NCT07019779
- Run by
- Keymed Biosciences Co.Ltd
- People needed
- 434
- Starts
- 2025-06-27
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Sun Yat-sen University Cancer Center (SYSUCC) — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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