Clinical trial NCT07019779: Study of CM518D1 in Patients With 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2025-06-13
Enrollment: 434
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)-Phase I dose escalation
timeFrame: First cycle (21 days)
measure: Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose escalation
timeFrame: Through study completion, an average of 2 years.
measure: Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose expansion
timeFrame: Through study completion, an average of 2 years.]
measure: Preliminary efficacy-Phase I dose expansion
timeFrame: Through study completion, an average of 2 years.]
measure: Objective response rate (ORR)-Phase II
timeFrame: Through study completion, an average of 2 years.]
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center (SYSUCC)
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Ruihua Xu
role: PRINCIPAL_INVESTIGATOR
References: