Clinical trial · Interventional
Safety and Efficacy of the Fully Humanized Anti - VEGF Monoclonal Antibody LYN00101
Phase I Study of the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of the Fully Humanized Anti - VEGF Monoclonal Antibody LYN00101 With Blocking of Autocrine Loops VEGFR1/2/3
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to recruit individuals for the study
Summary
Brief summary (as posted)
The purpose of this study is evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor effect of of fully human anti - VEGF monoclonal antibody LY00101 and explore the potential prognostic and predictive biomarkers. This study will not take into account the results of molecular-genetic tests of patients enrolled in the study
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Stomach Cancer | Malignant Gastric Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LYN00101 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LYN00101
- description
- Intravenous Infusion at the rate of 8 mg/kg of the patient's weight every 14 days.
- interventionNames
- Biological: LYN00101
Primary outcomes (14)
- measure
- Area under the concentration-time curve after single dose use
- timeFrame
- up to 14 days
- description
- Area under the concentration-time curve from 0 to ∞ with extrapolation of the final phase of the drug distribution
- measure
- Peak plasma concentration after single dose use
- timeFrame
- up to 14 days
- description
- Peak plasma concentration (Cmax) of T1h
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria:
* patients with histopathologically-documented, measurable or non measurable {evaluable}, advanced solid tumors refractory
* a life expectancy of \>3 months
* ECOG performance status score of ≤ 2 at study entry
* able to provide written informed consent.
* use of effective contraceptive measures if procreative potential exists.
* an absolute neutrophil count ≥1500/mm3
* a hemoglobin level ≥ 9gm/dL
* a platelet count ≥100,000/mm3
* a total bilirubin level ≤1.5 x the ULN
* aspartate transaminase (AST) and alanine transaminase (ALT) levels ≤2.5 x the ULN or ≤5 x the ULN if known liver metastases
* adequate renal function, as defined by a serum creatinine level ≤1.5 x the ULN.
Exclusion Criteria:
* patients with any active infection (nail bed induced fungal infections were excluded), chronic infections, and tuberculosis history.
* the females were pregnant, or lactating or showed positive urine pregnancy reaction during screening.
* patients with severe heart disease, heart failure, asthma, chronic obstructive pulmonary disease or neuropsychiatric diseases.
* uncontrolled diabetes or poor compliance with hypoglycemics;
* the presence of chronically unhealed wound or ulcers
* other chronic diseases, which, in the opinion of the investigator, could compromise safety of the patient or the integrity of study.
* newly-diagnosed or symptomatic brain metastases (patients with a history of brain metastases must have received definitive surgery or radiotherapy, be clinically stable, and not taking steroids for brain edema). Anticonvulsants are allowed.
* peritoneal carcinomatosis
* pregnancy (confirmed by serum beta human chorionic gonadotropin \[ßHCG\]) or breast-feeding (for female patients only).
* a known history or clinical evidence of a deep vein or arterial thrombosis, or pulmonary embolism
* less than six weeks from last infusion of any anti-VEGF monoclonal antibody therapy
* known history of human immunodeficiency virus infection (HIV).References
Publications (0)
Data not yet available