NCT02453464 is a Phase 1 clinical trial of Sevacizumab in Metastatic Colorectal Cancer, sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd..

Who is sponsoring NCT02453464?

NCT02453464 is sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd..

What drugs are being tested in NCT02453464?

Interventions in NCT02453464: Sevacizumab, Irinotecan, 5-FU, Leucovorin.

What condition does NCT02453464 study?

NCT02453464 studies Metastatic Colorectal Cancer.

Is NCT02453464 still recruiting?

NCT02453464 is currently status unknown. Last updated 19 April 2016.

Last reviewed 2016-04-19 · How we verify

NCT02453464

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 1 Last updated 19 April 2016

What this trial tests

Phase 1 trial testing Sevacizumab in Metastatic Colorectal Cancer in 36 participants. Status unknown.

Timeline

1 August 2015

Primary endpoint
1 December 2016

Quick facts

Lead sponsor	Jiangsu Simcere Pharmaceutical Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	1 August 2015
Primary completion	1 December 2016
Sites	3 locations across China

Drugs / interventions tested

Sevacizumab — full drug profile →
Irinotecan (irinotecan) — full drug profile →
5-FU
Leucovorin (leucovorin) — full drug profile →

Conditions studied

Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 18 to 74, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Maximum Tolerated Dose (MTD)
Time frame: up to 56 days

Sponsor's own description

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).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

From rabbit antibody repertoires to rabbit monoclonal antibodies.
Weber J, Peng H, Rader C. · · 2017 · cited 135× · PMID 28336958 · DOI 10.1038/emm.2017.23
Role of macrophages in tumor progression and therapy (Review).
Xu Y, Wang X, Liu L, Wang J, et al · · 2022 · cited 57× · PMID 35362544 · DOI 10.3892/ijo.2022.5347
The emerging role of immunotherapy in colorectal cancer.
Lynch D, Murphy A. · · 2016 · cited 51× · PMID 27668225 · DOI 10.21037/atm.2016.08.29
Hypoxia Increases Thyroid Cancer Stem Cell-Enriched Side Population.
Mahkamova K, Latar N, Aspinall S, Meeson A. · · 2018 · cited 22× · PMID 29167950 · DOI 10.1007/s00268-017-4331-x
Using DNA Immunization to Elicit Monoclonal Antibodies in Mice, Rabbits, and Humans.
Liu S, Wang S, Lu S. · · 2018 · cited 9× · PMID 30027758 · DOI 10.1089/hum.2018.077
Suvemcitug as second-line treatment of advanced or metastatic solid tumors and with FOLFIRI for pretreated metastatic colorectal cancer: phase Ia/Ib open label, dose-escalation trials.
Mao C, Ji D, Ding Y, Zhang Y, et al · · 2023 · cited 6× · PMID 37178668 · DOI 10.1016/j.esmoop.2023.101540

Verify or expand the search:

Other trials of Sevacizumab

Trials testing the same drug.

NCT03763123 — A Phase 1b Study of Sevacizumab in Combination With Chemotherapy in Chinese Patients With Platinum-Resistant Recurrent O · Phase 1 · unknown

Other recruiting trials for Metastatic Colorectal Cancer

Currently open trials in the same condition.

NCT07416552 — A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal Cancer (mCRC) · Phase 1 · recruiting
NCT07314294 — Phase II Study of EMB-01 in Recurrent/Metastatic Colorectal Cancer Patients · Phase 2 · recruiting
NCT06856837 — - IKF/AIO-QUINTIS - Evaluating Fruquintinib in Combination With Tislelizumab in Microsatellite Stable / Proficient Misma · Phase 2 · recruiting
NCT06959550 — Phase II Study of Anti-PD-1/VEGF Bispecific Antibody Ivonescimab in Patients With Previously Treated Metastatic Colorect · Phase 2 · recruiting
NCT06808685 — Real World Multicenter National Study to Evaluate the Effectiveness and Safety of Biosimilar Bevacizumab Elovie · recruiting

Other Jiangsu Simcere Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07345364 — A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics · Phase 1 · not yet recruiting
NCT07357610 — An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healt · Phase 1 · recruiting
NCT07175233 — A Phase 2 Study to Evaluate the Efficacy, Safety of SIM0278 in Subjects With Moderate to Severe Atopic Dermatitis · Phase 2 · not yet recruiting
NCT06686745 — Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors · Phase 1 · recruiting
NCT06680921 — A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+/HER2- Advanced Brea · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02453464 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jiangsu Simcere Pharmaceutical Co., Ltd.
Last refreshed: 19 April 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02453464.

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