Clinical trial · Interventional
A Phase Ib Study With Pegylated Recombinant Human Endostatin in Advanced / Metastatic NSCLC or Other Solid Tumors
A Phase Ⅰb Study Evaluating the Safety, Tolerability and Pharmacokinetics of Pegylated Recombinant Human Endostatin (PEG-ENDO) in Subjects With Advanced / Metastatic Non-small Cell Lung Cancer (NSCLC) or Other Solid Tumors
- 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)
The primary purpose of this study is to examine the safety, tolerability and pharmacokinetics of PEG-ENDO in combination with docetaxel in subjects previously treated or untreated (standard therapy is not suitable or without standard therapy) for advanced or metatatic non-small cell lung cancer (NSCLC) or other solid tumors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pegylated Recombinant Human Endostatin（PEG-ENDO） | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEG-ENDO+Docetaxel
- description
- PEG-ENDO( 1 mg/kg or 2mg/kg or 4mg/kg or 6mg/kg or 8mg/kg）+Docetaxel 75 mg/m2，once every 3 weeks at day 1
- interventionNames
- Drug: Pegylated Recombinant Human Endostatin（PEG-ENDO）
Primary outcomes (11)
- measure
- Dose Limiting Toxicities (DLT)
- timeFrame
- First 21days for dosing（Cycle1，each cycle is 21 days)
- description
- Incidence of Dose Limiting Toxicity
- measure
- Adverse Event(AE)
- timeFrame
- From the time the subjects signed the Informed Consent Form to 28 days after the end of the study drug treatment
- description
- Incidence of Adverse Events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provision of signed and dated, written informed consent. 2. 18-70years old, male or female. 3. Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer(NSCLC) or other solid tumor, previous treated with standard therapy , or standard therapy not suitabl ,or without standard therapy. 4. At least one measurable disease according to RECIST v1.1. 5. Life expectancy of at least 3 months. 6. Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1. 7. Demonstrate adequate organ function - Exclusion Criteria: 1. uncontrolled primary CNS tumors, brain metastases, or meningeal metastases. 2. Evidence of a tumor that compresses or invades major blood vessels. 3. History of hemoptysis (\>1/2 teaspoon per event) or severe bleeding or evidence of bleeding disorders in the last 3 months. 4. Clinically significant active cardiovascular disease within 6 months prior to planned start of PEG-ENDO. 5. Prior treatment with anti-agiogenetic agent. 6. Pregnant female patients; breastfeeding female patients. \-
References
Publications (0)
Data not yet available