Study of CM518D1 in Patients With Advanced Solid Tumors

Keymed Biosciences

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Biological: CM518D1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07019779

CM518D1-030101

Details and patient eligibility

About

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

Enrollment: 434 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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434 participants in 3 patient groups

Phase I dose escalation

Experimental group

Treatment:

Biological: CM518D1

Biological: CM518D1

Biological: CM518D1

Phase I dose expansion

Experimental group

Treatment:

Biological: CM518D1

Biological: CM518D1

Biological: CM518D1

Phase II

Experimental group

Treatment:

Biological: CM518D1

Biological: CM518D1

Biological: CM518D1