CM518D1 treatment for advanced solid tumors
Official title: A Multicenter, Open-Label, Phase I/II Clinical Study to Evaluate CM518D1 in the Treatment of Patients With Advanced Solid Tumors
Run by Keymed Biosciences Co.Ltd · NCT07019779 · Data updated 2026-11-12
This trial will test CM518D1 to see if it is safe, tolerable, and can help adults with advanced solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 434 (estimated) |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | June 27, 2025 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2029 |
| Registry record updated | June 15, 2026 |
| Trial ID | NCT07019779 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with histologically or cytologically confirmed advanced solid tumors, at least one measurable lesion, expected survival ≥3 months, and who meet the timing and medication restrictions on prior therapies are the intended candidates.
✕Probably not a fit
Patients who recently received other anti-cancer treatments, had recent major surgery or radiotherapy, require high-dose steroids or other immunosuppression, or who have very limited life expectancy are unlikely to qualify or benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1/2 interventional program gives adults with histologically or cytologically confirmed advanced solid tumors a series of CM518D1 doses to characterize safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity. Eligible participants must have at least one measurable lesion by RECIST v1.1 and an expected survival of three months or more. Key exclusions include recent anti-cancer therapies (within ~28 days), recent major surgery or radiotherapy, and active high-dose systemic steroids or other immunosuppression. The study is sponsored by Keymed Biosciences and conducted at Sun Yat-sen University Cancer Center in Guangzhou, China.
Why it matters
Potential benefit: If successful, CM518D1 could provide a new treatment option that shrinks tumors or slows disease progression for some patients with advanced solid tumors.
How similar studies have gone: Early-phase programs of novel targeted or biologic agents in advanced solid tumors have produced responses in selected patients, but CM518D1 itself appears to be a novel agent with limited or no published efficacy data to date.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Sun Yat-sen University Cancer Center (SYSUCC)
Guangzhou, Guangdong, China Recruiting
Study contacts
- Principal investigator: Ruihua Xu — Sun Yat-Sen University Cancer Center
- Study coordinator: Qian Jia
- Email: qianjia@keymedbio.com
- Phone: 028-88610620
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.