Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02187848
Other study ID # TED13751
Secondary ID U1111-1153-34612
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date July 23, 2014
Est. completion date August 30, 2024

Study information

Verified date February 2024
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Primary Objectives: - To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 2 weeks (with and without a loading dose at Cycle 1) to patients with advanced solid tumors (Main Escalation and Loading Dose Escalation Q2W). - To determine the maximum tolerated dose (MTD) of SAR408701 administered as monotherapy, once every 3 weeks to patients with advanced solid tumors (Escalation Q3W Cycle). - To assess efficacy according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) (Expansion Phase) when SAR408701 is administered once every 2 weeks with or without a loading dose at Cycle 1. Secondary Objectives: - To characterize the overall safety profile of SAR408701. - To characterize the pharmacokinetic (PK) profile of SAR408701 and of its potential circulating derivatives. - To identify the recommended phase 2 dose (RP2D) of SAR408701. - To assess the potential immunogenicity of SAR408701.


Description:

The study duration for an individual patient will start from the signature of the informed consent, will include a period to assess eligibility (screening period) of up to approximately 4 weeks (28 days), a treatment period and an end-of-treatment visit around 30 days following the last administration of study drug, and at least one follow-up visit after the end-of-treatment visit. Additional follow-up visits may be required until resolution or stabilization of adverse events (at least 30 days). Treatment may continue until precluded by toxicity, progression, or upon patient's request. If the patient stops study treatment for reason other than disease progression, follow-up visit will be performed every 3 months until disease progression or initiation of another anti-tumor treatment or death, whichever comes first.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 254
Est. completion date August 30, 2024
Est. primary completion date November 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Locally advanced or metastatic solid malignant tumor disease for which no standard alternative therapy is available. - Availability of archived tumor tissue for carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5 or CEA) testing. - For participants in the Dose Escalation Cohorts (Main Escalation and Loading Dose Cohorts at every 2 week cycle and Dose Escalation every 3 week cycle): patients with tumors expressing or likely to be expressing CEACAM5 which includes colorectal cancer (CRC), non-squamous non-small cell lung cancer (NSCLC), gastric adenocarcinoma, squamous cell carcinoma of the cervix, pancreas adenocarcinoma, bladder transitional cell carcinoma, cholangiocarcinoma, epithelial ovarian cancer and endometrial adenocarcinoma are favored, or if carcinoembryonic antigen (CEA) plasma levels >5 ng/mL. - For participants to the Expansion Phase cohorts: patients with CRC or with CEACAM5 positive non-squamous NSCLC, small cell lung cancer (SCLC) or gastric carcinoma (including esophago-gastric junction adenocarcinoma of the Siewert types II and III). - At least one measurable lesion by RECIST v1.1 in the Expansion Phase only. - At least one lesion amenable to biopsy (Expansion cohort - CRC and gastric cancer only). Patient must consent to a baseline biopsy for retrospective confirmation of tumor CEACAM5 expression, except if NSCLC or SCLC without lesion amenable to biopsy. - Signed informed consent. Exclusion criteria: - Aged less than 18 years. - Eastern Cooperative Oncology Group (ECOG) performance status more than 1. - New or progressing brain involvement. - Concurrent treatment with any other anticancer therapy or inadequate wash-out period for prior anticancer therapies before first administration of SAR408701, or non-resolution of toxicities induced by these anticancer therapies. - Female or male patients with reproductive potential who do not agree to use an accepted effective method of contraception during the study treatment period and for at least 3 months following completion of study treatment. - Pregnancy or breast-feeding. - Participation to any clinical research study evaluating another investigational drug or therapy within 3 weeks of initiation of study regimen. - Prior therapy targeting CEACAM5. - Prior maytansinoid treatments (DM1 or DM4 antibody drug conjugates). - Poor bone marrow reserve resulting in low blood cell counts. - Poor kidney and liver functions. - Any of the following within 6 months prior to study enrolment: infectious or inflammatory bowel disease, diverticulitis, gastrointestinal perforation, intestinal obstruction, and gastrointestinal hemorrhage. Patients with malabsorption syndrome are excluded. - Previous history and or unresolved corneal disorders. The use of contact lenses is not permitted. - Unresolved signs and symptoms of neuropathy; Grade 1 is acceptable if prior neurotoxic drugs such as cisplatin or taxanes. - Abnormal cardiac function defined by a left ventricular ejection fraction (LVEF) of <50%. - Cardiac conduction defects, or any other clinically significant arrhythmias. - Known intolerance to infused protein products. - Medical conditions requiring concomitant administration of medications with narrow therapeutic window, metabolized by cytochrome P450 (CYPs) enzymes and for which a dose reduction cannot be considered. - Medical conditions requiring concomitant administration of strong CYP3A inhibitor, unless it can be discontinued at least 2 weeks before 1st administration of SAR408701. - Contraindications to the use of ophthalmic vasoconstrictor and/or corticosteroid as per package insert of each drug, including the following: increase intraocular pressure, prior or current glaucoma, narrow-angle glaucoma, ongoing eye infection, uncontrolled hypertension, known/suspected allergy to constituents of the preparation (such as sodium bisulfite). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SAR408701
Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous

Locations

Country Name City State
Canada Investigational Site Number : 124001 Toronto Ontario
France Investigational Site Number : 250003 Bordeaux Cedex
France Investigational Site Number : 250006 Dijon
France Investigational Site Number : 250004 Marseille
France Investigational Site Number : 250007 Rennes
France Investigational Site Number : 250005 Saint Mande
France Investigational Site Number : 250002 TOULOUSE Cedex 9
France Investigational Site Number : 250001 Villejuif
Korea, Republic of Investigational Site Number : 410001 Seoul Seoul-teukbyeolsi
Korea, Republic of Investigational Site Number : 410002 Seoul Seoul-teukbyeolsi
Korea, Republic of Investigational Site Number : 410003 Seoul Seoul-teukbyeolsi
Korea, Republic of Investigational Site Number : 410004 Seoul Seoul-teukbyeolsi
Korea, Republic of Investigational Site Number : 410005 Seoul Seoul-teukbyeolsi
Spain Investigational Site Number : 724001 Barcelona Barcelona [Barcelona]
Spain Investigational Site Number : 724003 Madrid Madrid, Comunidad De
Spain Investigational Site Number : 724006 Madrid
Spain Investigational Site Number : 724004 Madrid / Madrid Madrid, Comunidad De
Spain Investigational Site Number : 724002 Majadahonda Madrid
United States Dana Farber Cancer Institute Site Number : 840005 Boston Massachusetts
United States Yale University School of Medicine Site Number : 840002 New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada,  France,  Korea, Republic of,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of dose limiting adverse events (every 2 week cycle) 4 weeks
Primary Assessment of overall response rate using standard imaging and RECIST 1.1 criteria Up to 40 months
Primary Number of dose limiting adverse events (every 3 week cycle) 3 weeks
Secondary Number of treatment emergent adverse events Up to 4 years
Secondary Maximum concentration (Cmax) 2 months
Secondary Time to reach maximum concentration (tmax) 2 months
Secondary Trough plasma concentrations (Ctrough) Intensive testing within first 2 months, then every 2 weeks
Secondary Area under the plasma concentration versus time curve between 0 and 14 days (AUC0-14day) for Q2W or between 0 and 21 days (AUC-21 day) for Q3W 2 months
Secondary Mean systemic clearance (CL) 2 months
Secondary Clearance at steady state (CLss) 2 months
Secondary Accumulation ratio (Rac) on AUC0-14day and Cmax 2 months
Secondary Detection of the development of anti-SAR408701 antibody Up to 40 months
Secondary Duration of response Up to 40 months - assessment every 6-8 weeks
Secondary Time to Progression Up to 40 months - assessment every 6-8 weeks
See also
  Status Clinical Trial Phase
Completed NCT01156870 - First in Man Study of SAR566658 Administered in Patients With CA6-Positive and Refractory Solid Tumor Phase 1
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Completed NCT01930552 - A Phase I Study of Aflibercept Plus FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) in Chinese Patients With Advanced Solid Malignancies Phase 1
Completed NCT01657214 - Phase I, Dose Escalation of SAR125844 in Asian Solid Tumor Patients Phase 1
Active, not recruiting NCT03911388 - HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors Phase 1
Completed NCT02575781 - A Study of SAR428926 in Patients With Advanced Solid Tumors Phase 1
Completed NCT01943838 - A Study of the Safety and Pharmacokinetics of SAR245408 Tablets in Patients With Solid Tumors or Lymphoma Phase 1
Completed NCT03324113 - Evaluation of SAR408701 in Japanese Patients With Advanced Malignant Solid Tumors Phase 1
Recruiting NCT06238687 - A Study of STRO-002 in Chinese Adults With Epithelial Ovarian Cancer and Other Advanced Malignant Solid Tumors Phase 1/Phase 2
Completed NCT02435121 - A Study Assessing Efficacy and Safety of SAR125844 in NSCLC Patients With MET Amplification Phase 2
Completed NCT01985191 - A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer Patients Phase 1
Completed NCT01455532 - A Dose Escalation Study of Iniparib as a Single Agent and in Combination in Solid Tumors Phase 1
Active, not recruiting NCT03491631 - Phase I Study of SHR9146 + SHR-1210 +/- Apatinib in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT04067388 - iKnife REIMS Project
Completed NCT01836705 - Effect of SAR302503 on ECG Activity in Patients With Solid Tumors Phase 1
Completed NCT01140607 - Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment Phase 1
Recruiting NCT04495790 - AIMS Cancer Outcomes Study
Recruiting NCT05714553 - NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours Phase 1/Phase 2
Recruiting NCT04733469 - EMPOWER 3: Improving Palliative Care Health Literacy and Utilization N/A
Active, not recruiting NCT03845166 - A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors Phase 1