Study of CM518D1 in Patients With Advanced Solid Tumors

NCT07019779 | Recruiting Phase 1

• 1 other identifier: CM518D1-030101
• Study Type: interventional
• Target: 434
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Dose Limiting Toxicity (DLT)-Phase I dose escalation

  DLT is defined as a toxicity occurring during the DLT observation period.

  First cycle (21 days)

• Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose escalation

  An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.

  Through study completion, an average of 2 years.

• Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose expansion

  An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.

  Through study completion, an average of 2 years.]

• Preliminary efficacy-Phase I dose expansion

  Preliminary efficacy includes objective response rate (ORR), duration of response (DOR), disease control rate (DCR), time to response (TTR), and progression-free survival (PFS).

  Through study completion, an average of 2 years.]

• Objective response rate (ORR)-Phase II

  ORR is defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to Response Evaluation Criteria in Solid Tumors( RECIST) v1.1.

  Through study completion, an average of 2 years.]

Study Arms (3)

Phase I dose escalation

EXPERIMENTAL

Biological: CM518D1

Phase I dose expansion

EXPERIMENTAL

Biological: CM518D1

Phase II

EXPERIMENTAL

Biological: CM518D1

Interventions

CM518D1 BIOLOGICAL

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

Phase I dose escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Male or female ≥ 18 and ≤75 years of age.
• \. Subjects with histologically or cytologically confirmed advanced solid tumors.
• \. At least one measurable lesion according to RECIST v1.1.
• \. Expected survival time ≥ 3 months as judged by the Investigator.

You may not qualify if:

• \. 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).
• \. Subjects who have received major surgery within 28 days prior to the first dose.
• \. Subjects who have received radiotherapy within 21 days prior to the first dose.
• \. 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.
• \. Subjects who have received any CDH17-targeted therapy.
• \. 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.
• \. Hypersensitivity to the investigational drug or its excipients.
• \. Pregnant or lactating female patients.

Sponsors & Collaborators

• Keymed Biosciences Co.Ltd: lead

Study Sites (1)

Sun Yat-sen University Cancer Center (SYSUCC)

Guangzhou, Guangdong, China

RECRUITING

Study Officials

• Ruihua Xu

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jia

CONTACT

028-88610620; qianjia@keymedbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 13, 2025
• Study Start: June 27, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)