Clinical trial · Interventional
A Phase Ib Study of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection Plus FOLFIRI in Chinese Patients With Metastatic Colorectal Cancer
A Phase Ib, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody(Sevacizumab) Injection Plus FOLFIRI in Chinese Patients With Metastatic Colorectal Cancer
- 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 open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of Humanized Anti-VEGF Monoclonal Antibody (Sevacizumab) Injection in combination with FOLFIRI in patients with previously treated metastatic colorectal cancer. This study includes two stages. Stage 1 is the dose-escalation stage. Once the maximum tolerated dose (MTD) of Sevacizumab has been established, additional patients will be enrolled in the cohort-expansion stage (Stage 2).
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
| Sevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sevacizumab+FOLFIRI
- description
- Two weeks as one cycle. Cycle 1: FOLFIRI on day1-2, Sevacizumab on day3; Cycle 2 and after: Sevacizumab on day 1, and then FOLFIRI on day1-2
- interventionNames
- Drug: Sevacizumab
- Drug: Irinotecan
- Drug: 5-FU
- Drug: Leucovorin
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD)
- timeFrame
- up to 56 days
Secondary outcomes (9)
- measure
- Adverse Events (NCI-CTC 4.0)
- timeFrame
- 28 days after the last dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Histological/cytological confirmed unresectable metastatic colorectal cancer patients who have failed first-line oxaliplatin-based chemotherapy * At least one measurable lesion (according to RECIST 1.1 ) * At least 4 weeks from the last chemotherapy. 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); 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 * Patients signed written inform consent * Willingness and capability to communicate with investigators and to comply with protocol requirements Exclusion Criteria: * HCV, TP or HIV antibody positive * Previously received anti-VEGF protein drugs, such as Bevacizumab,Sevacizumab * Previously treated with irinotecan * History of dihydropyrimidine dehydrogenase deficiency * Patients with alcohol or drug dependence * Participation in other clinical trials within 4 weeks before enrollment * Active or chronic hepatitis B infection with HBV DNA \> 1.0 \* 10\^3 IU/mL * Serious infection requiring intravenous antibiotic therapy * 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 * History of intestinal obstruction, inflammatory bowel disease, or other intestinal diseases with chronic diarrhea as the major symptom * 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 * Expected to receive surgery during the study or within 1 month after the last dose * The investigators consider the patients are not suitable for this trial * Pregnant and lactating women * Known allergies to any excipient in the study drug * Patients can not complete this study for any other reason
References
Publications (0)
Data not yet available