CM518D1 treatment for advanced solid tumors

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

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
• Enrollment: 434 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Keymed Biosciences Co.Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07019779 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center (SYSUCC) — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Ruihua Xu — Sun Yat-sen University
• Study coordinator: Qian Jia

Conditions Advanced Solid Tumors