Clinical trial · Interventional
Study of CM518D1 in Patients With Advanced Solid Tumors
A Multicenter, Open-Label, Phase I/II Clinical Study to Evaluate CM518D1 in the Treatment of Patients With Advanced Solid Tumors
NCT07019779CI-TRIAL-00114740recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an interventional study to assess the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CM518D1 in patients with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CM518D1 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase I dose escalation
- interventionNames
- Biological: CM518D1
- type
- EXPERIMENTAL
- label
- Phase I dose expansion
- interventionNames
- Biological: CM518D1
- type
- EXPERIMENTAL
- label
- Phase II
- interventionNames
- Biological: CM518D1
Primary outcomes (5)
- measure
- Dose Limiting Toxicity (DLT)-Phase I dose escalation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.