Clinical Trials in China / NCT07893171
Starting soon
Phase 1/2
Study of CM529D1 in Participants With Advanced Solid Tumors
NCT07893171 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advanced Solid Tumors
Investigational drug(s) / intervention(s)
CM529D1CM529D1CM529D1
CM529D1: CM529D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels.
CM529D1: CM529D1 will be administered intravenously once every 3 weeks (Q3W) in one or more potential recommended phase 2 dose(RP2D).
CM529D1: CM529D1 will be administered intravenously once every 3 weeks (Q3W) in different types of solid tumor cohorts.
Study summary
This is interventional study to evaluate the safety and tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of CM529D1 in participants with advanced solid tumors.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Dose Limiting Toxicity (DLT)-Phase I dose escalation — First cycle (21 days)
DLT is defined as a toxicity occurring during the DLT observation period. - Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose escalation — Through study completion, an average of 2 years
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. - The Recommended Phase 2 Dose (RP2D)Phase I dose expansion — Through study completion, an average of 2 years
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. - Objective response rate (ORR)-Phase II — Through study completion, an average of 2 years
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.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | China |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07893171 on ClinicalTrials.gov ↗ ← All trials in China