Study of CM518D1 in Patients With Advanced Solid Tumors

NCT ID: NCT07019779

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 434 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-27
• Study Completion Date: 2029-12-31

Brief Summary

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

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase I dose escalation

Group Type: EXPERIMENTAL

CM518D1

Intervention Type: BIOLOGICAL

CM518D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels.

Phase I dose expansion

Group Type: EXPERIMENTAL

CM518D1

Intervention Type: BIOLOGICAL

CM518D1 will be administered intravenously once every 3 weeks (Q3W) in one or more potential recommended phase 2 dose(RP2D).

Phase II

Group Type: EXPERIMENTAL

CM518D1

Intervention Type: BIOLOGICAL

CM518D1 will be administered intravenously once every 3 weeks (Q3W) in different types of solid tumor cohorts.

Interventions

CM518D1

CM518D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels.

Intervention Type: BIOLOGICAL

CM518D1

CM518D1 will be administered intravenously once every 3 weeks (Q3W) in one or more potential recommended phase 2 dose(RP2D).

Intervention Type: BIOLOGICAL

CM518D1

CM518D1 will be administered intravenously once every 3 weeks (Q3W) in different types of solid tumor cohorts.

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Keymed Biosciences Co.Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruihua Xu

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center (SYSUCC)

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qian Jia

Role: CONTACT

qianjia@keymedbio.com

028-88610620

Facility Contacts

Ruihua Xu, Dr.

Role: primary

xurh@sysucc.org.cn

020-87343468

Other Identifiers

CM518D1-030101

Identifier Type: -

Identifier Source: org_study_id