Study of CM529D1 in Participants With Advanced Solid Tumors

NCT07893171 | Not Yet Recruiting Phase 1

• 1 other identifier: CM529D1-030101
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This is interventional study to evaluate the safety and tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of CM529D1 in participants with advanced solid tumors.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• 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) v6.0 criteria.

  Through study completion, an average of 2 years

• The Recommended Phase 2 Dose (RP2D)Phase I dose expansion

  RP2D is defined as the dose selected at the conclusion of Phase 1 dose- expansion, based on the integrated assessment of safety, tolerability, pharmacokinetics, and preliminary antitumor activity, and recommended for further evaluation in Phase 2 studies.

  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: CM529D1

Phase I dose expansion

EXPERIMENTAL

Biological: CM529D1

Phase II

EXPERIMENTAL

Biological: CM529D1

Interventions

CM529D1 BIOLOGICAL

CM529D1 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.
• Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
• Participants 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:

• Participants have received prior therapy with antibody-drug conjugates bearing a camptothecin or camptothecin derivative payload.
• Participants who have received any chemotherapy, any anti-tumor therapy (including monoclonal antibodies, targeted therapy, radioimmunoconjugates, or Antibody-Drug Conjugates), or other investigational drugs within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of investigational product.
• Participants who have received major surgery within 28 days prior to the first dose.
• Participants who have received radiotherapy within 21 days prior to the first dose.
• Participants 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.
• Participants with symptomatic central nervous system metastases.
• History of any-grade interstitial lung disease (ILD) or known/suspected ILD.
• 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)

Shanghai Chest Hospital

Shanghai, China

Location

Central Study Contacts

Qian Jia

CONTACT

028-88610620; clinicaltrial@keymedbio.com

Study Design

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

Study Record Dates

• First Submitted: October 16, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): November 27, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 23, 2026

Record last verified: 2026-10

Locations

CN (1)