Clinical trial · Interventional
A Phase Ia, Dose Escalation Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in Patients With Advanced or Metastatic Solid Tumors
NCT01847118CI-TRIAL-00017212unknownPhase 1ClinicalTrials.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 study is to assess the safety, tolerability and pharmacokinetics of single dose and multiple doses of humanized anti-VEGF monoclonal antibody (Sevacizumab) in patients with advanced or metastatic solid tumors. The secondary objective is to explore the preliminary anti-tumor effects.
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sevacizumab
- description
- 2mg/kg、5mg/kg、7.5mg/kg、10mg/kg、12.5mg/kg、or 15mg/kg. d1, d29, d43, d57
- interventionNames
- Drug: Sevacizumab
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- up to 28 days
Secondary outcomes (6)
- measure
- Cmax
- timeFrame
- d1, d2, d5, d8, d11, d15, d18, d22, d25,d29, d43, d57
- measure
- tmax
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed advanced or metastatic malignant solid tumors; * Patients failed the standard anti-tumor therapy or don't have standard regimen; * At least one measurable lesion; * At least 4 weeks from the last chemotherapy, 6 weeks from mitomycin, and nitrosourea treatment. If patients received anti-tumor biological products, at least four t1/2 of washout period is needed; * Toxicity from previous treatment has to restore to ≤ grade 1 (NCI CTC4.0); * ECOG performance status 0-1; * Life expectancy ≥ 3 months; * Adequate hematologic function: ANC ≥ 1.5 × 10\^9 /L, HB ≥ 90 g /L (blood transfusion allowed), PLT ≥ 100 × 10\^9 /L; * Adequate hepatic function: ALT ≤ 2.5 × ULN, AST ≤ 2.5 × ULN, TBIL ≤ 1.5 × ULN (patients with liver metastases ALT ≤ 5 × ULN, AST ≤ 5 × ULN, TBIL ≤ 3 × ULN); * Adequate renal function: creatinine ≤ 1 × ULN; * Coagulation function: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN; * Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 12 weeks after the last dose. Exclusion Criteria: * HCV, TP or HIV antibody positive; * Previously received anti-VEGF protein drugs, such as bevacizumab; * Histologically proven squamous cell lung cancer or squamous cell carcinoma of the head and neck; * Active hepatitis B infection; * Evidence of serious infection; * Symptomatic brain metastases; * Patients with proteinuria at screening (urine protein ≥ 1+); * History of abdominal fistula, gastrointestinal perforation, abdominal abscess within 6 months prior to enrollment; * Serious non-healing wounds, ulcers or fractures; * Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment; * Active bleeding within 3 months prior to enrollment; * Bleeding diathesis or coagulation disorder; * History of arterial or venous thrombosis; * History of myocardial infarction or stroke within 6 months prior to enrollment; * Unstable angina, congestive heart failure, New York Heart Association (NYHA) class II heart failure, uncontrollable arrhythmia, uncontrolled hypertension (systolic blood pressure\> 150 mmHg and/or diastolic blood pressure\> 100 mmHg); * Pregnant and lactating women; * Known allergies to any excipient in the study drug; * Patients with alcohol or drug dependence; * Participation in other clinical trials within 4 weeks before enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.