Neoplasm MalignantPhase 1NCT02187848
Evaluation of SAR408701 in Patients With Advanced Solid Tumors
A Phase 1 study testing SAR408701 in people with Neoplasm Malignant, run by Sanofi at 20 sites in 5 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant
- What is being tested?
- SAR408701
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 23 Jul 2014to 19 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
France7 sites
Investigational Site Number : 250003
Bordeaux, 33076
Investigational Site Number : 250006
Dijon, 21079
Investigational Site Number : 250004
Marseille, 13385
Investigational Site Number : 250007
Rennes, 35000
Investigational Site Number : 250005
Saint-Mandé, 94163
Investigational Site Number : 250002
Toulouse, 31059
Investigational Site Number : 250001
Villejuif, 94800
South Korea5 sites
Investigational Site Number : 410002
Seoul, Seoul-teukbyeolsi, 03080
Investigational Site Number : 410005
Seoul, Seoul-teukbyeolsi, 03722
Investigational Site Number : 410003
Seoul, Seoul-teukbyeolsi, 06351
Investigational Site Number : 410004
Seoul, Seoul-teukbyeolsi, 07061
Investigational Site Number : 410001
Seoul, Seoul-teukbyeolsi, 138-736
Spain5 sites
Investigational Site Number : 724001
Barcelona, Barcelona [Barcelona], 08035
Investigational Site Number : 724003
Madrid, Madrid, Comunidad de, 28050
Investigational Site Number : 724006
Madrid, 28041
Investigational Site Number : 724004
Madrid / Madrid, Madrid, Comunidad de, 28040
Investigational Site Number : 724002
Majadahonda, Madrid, 28222
United States2 sites
Dana Farber Cancer Institute- Site Number : 840005
Boston, Massachusetts, 02115
Yale University School of Medicine Site Number : 840002
New Haven, Connecticut, 06520-8017
About this study
Official title: A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors
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.
Read more
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.
Read the detailed 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.
- Conditions
- Neoplasm Malignant
- Being tested
- SAR408701
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR408701Drug
Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous
| Study group | Role | What they receive |
|---|---|---|
| SAR408701 Main Dose Escalation Cohort | Experimental | Dose escalation administered intravenously, once every two weeks Receives: Drug: SAR408701 |
| SAR408701 Expansion Cohort colorectal cancer (CRC) | Experimental | Administered intravenously at the maximum tolerated dose (MTD), once every 2 weeks, to patients with colorectal cancer Receives: Drug: SAR408701 |
| SAR408701 Expansion Cohort non-squamous NSCLC | Experimental | Administered intravenously at the MTD, once every 2 weeks, to patients with carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expressing non-squamous non-small cell lung cancer (NSCLC) of at least 50% of tumor cells at or above 2+ intensity Receives: Drug: SAR408701 |
| SAR408701 Expansion Cohort gastric adenocarcinoma | Experimental | Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing gastric adenocarcinoma Receives: Drug: SAR408701 |
| SAR408701 Loading Dose Escalation cohorts (Escalation bis) | Experimental | Loading dose escalation administered intravenously at first cycle, followed by MTD, once every 2 weeks Receives: Drug: SAR408701 |
| SAR408701 Expansion Cohort non-squamous NSCLC (Lung bis) | Experimental | Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing non-squamous NSCLC of at least 1% but below 50% of tumor cells at or above 2+ intensity Receives: Drug: SAR408701 |
| SAR408701 Expansion Cohort colorectal cancer (CRC-L) | Experimental | Loading dose of determined MTD-L administered intravenously at first cycle, followed by MTD, once every 2 weeks Receives: Drug: SAR408701 |
| SAR408701 Expansion Cohort small cell lung cancer (SCLC) | Experimental | Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing SCLC Receives: Drug: SAR408701 |
| SAR408701 Dose Escalation every 3 weeks cohort | Experimental | Dose escalation administered intravenously, once every three weeks Receives: Drug: SAR408701 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dose limiting adverse events (every 2 week cycle)
Measured: 4 weeks
Assessment of overall response rate using standard imaging and RECIST 1.1 criteria
Measured: Up to 40 months
Number of dose limiting adverse events (every 3 week cycle)
Measured: 3 weeks
Secondary outcomes (11)
Number of treatment emergent adverse events
Measured: Up to 4 years
Maximum concentration (Cmax)
Measured: 2 months
Time to reach maximum concentration (tmax)
Measured: 2 months
Trough plasma concentrations (Ctrough)
Measured: Intensive testing within first 2 months, then every 2 weeks
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
Measured: 2 months
Mean systemic clearance (CL)
Measured: 2 months
Clearance at steady state (CLss)
Measured: 2 months
Accumulation ratio (Rac) on AUC0-14day and Cmax
Measured: 2 months
Detection of the development of anti-SAR408701 antibody
Measured: Up to 40 months
Duration of response
Measured: Up to 40 months - assessment every 6-8 weeks
Time to Progression
Measured: Up to 40 months - assessment every 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study start23 Jul 2014
- Primary completion10 Nov 2020
- Study completion19 Nov 2024
Why it stopped: Sponsor decision, The decision is not related to any safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187848
- Sponsor's protocol ID
- TED13751
- Other IDs
- U1111-1153-3461, 2014-001130-29, 2014
- Status last verified
- Feb 2025
- First submitted
- 24 Jun 2014
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Publications
Gazzah A, Bedard PL, Hierro C, Kang YK, Abdul Razak A, Ryu MH, Demers B, Fagniez N, Henry C, Hospitel M, Soria JC, Tabernero J. Safety, pharmacokinetics, and antitumor activity of the anti-CEACAM5-DM4 antibody-drug conjugate tusamitamab ravtansine (SAR408701) in patients with advanced solid tumors: first-in-human dose-escalation study. Ann Oncol. 2022 Apr;33(4):416-425. doi: 10.1016/j.annonc.2021.12.012. Epub 2022 Jan 10.
PubMed 35026412Tabernero J, Bedard PL, Bang YJ, Vieito M, Ryu MH, Fagniez N, Chadjaa M, Soufflet C, Masson N, Gazzah A. Tusamitamab Ravtansine in Patients with Advanced Solid Tumors: Phase I Study of Safety, Pharmacokinetics, and Antitumor Activity Using Alternative Dosing Regimens. Cancer Res Commun. 2023 Aug 28;3(8):1662-1671. doi: 10.1158/2767-9764.CRC-23-0284. eCollection 2023 Aug.
PubMed 37645622Gazzah A, Ternes N, Lee JS, Wang E, Carene D, Wang H, Masson N, Boitier E, Lartigau A, Mace N, Chadjaa M, Dib C, Nunes M, Muzard G, Longuemaux-Valence S, Bauchet AL. Biomarker analysis from a Phase 1/1b study of tusamitamab ravtansine in patients with advanced non-small cell lung cancer. Transl Oncol. 2026 Jan;63:102615. doi: 10.1016/j.tranon.2025.102615. Epub 2025 Dec 3.
PubMed 41337813
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human Study for the Evaluation of the Safety, Pharmacokinetics and Antitumor Activity of SAR408701 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02187848
- Acronym / sponsor ID
- TED13751
- Conditions
- Neoplasm Malignant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision, The decision is not related to any safety concern.
- Enrolment
- 254 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 23 Jul 2014 (actual)
- Primary completion
- 10 Nov 2020 (actual)
- Study completion
- 19 Nov 2024 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| SAR408701 Main Dose Escalation Cohort | Experimental | Drug: SAR408701Dose escalation administered intravenously, once every two weeks |
| SAR408701 Expansion Cohort colorectal cancer (CRC) | Experimental | Drug: SAR408701Administered intravenously at the maximum tolerated dose (MTD), once every 2 weeks, to patients with colorectal cancer |
| SAR408701 Expansion Cohort non-squamous NSCLC | Experimental | Drug: SAR408701Administered intravenously at the MTD, once every 2 weeks, to patients with carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) expressing non-squamous non-small cell lung cancer (NSCLC) of at least 50% of tumor cells at or above 2+ intensity |
| SAR408701 Expansion Cohort gastric adenocarcinoma | Experimental | Drug: SAR408701Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing gastric adenocarcinoma |
| SAR408701 Loading Dose Escalation cohorts (Escalation bis) | Experimental | Drug: SAR408701Loading dose escalation administered intravenously at first cycle, followed by MTD, once every 2 weeks |
| SAR408701 Expansion Cohort non-squamous NSCLC (Lung bis) | Experimental | Drug: SAR408701Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing non-squamous NSCLC of at least 1% but below 50% of tumor cells at or above 2+ intensity |
| SAR408701 Expansion Cohort colorectal cancer (CRC-L) | Experimental | Drug: SAR408701Loading dose of determined MTD-L administered intravenously at first cycle, followed by MTD, once every 2 weeks |
| SAR408701 Expansion Cohort small cell lung cancer (SCLC) | Experimental | Drug: SAR408701Administered intravenously at the MTD, once every 2 weeks, to patients with CEACAM5 expressing SCLC |
| SAR408701 Dose Escalation every 3 weeks cohort | Experimental | Drug: SAR408701Dose escalation administered intravenously, once every three weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR408701Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous | Drug | SAR408701 Dose Escalation every 3 weeks cohort, SAR408701 Expansion Cohort colorectal cancer (CRC), SAR408701 Expansion Cohort colorectal cancer (CRC-L), SAR408701 Expansion Cohort gastric adenocarcinoma, SAR408701 Expansion Cohort non-squamous NSCLC, SAR408701 Expansion Cohort non-squamous NSCLC (Lung bis), SAR408701 Expansion Cohort small cell lung cancer (SCLC), SAR408701 Loading Dose Escalation cohorts (Escalation bis), SAR408701 Main Dose Escalation Cohort |
Primary outcome
Number of dose limiting adverse events (every 2 week cycle)
Time frame: 4 weeks
Assessment of overall response rate using standard imaging and RECIST 1.1 criteria
Time frame: Up to 40 months
Number of dose limiting adverse events (every 3 week cycle)
Time frame: 3 weeks
11 secondary outcomes
Number of treatment emergent adverse events
Time frame: Up to 4 years
Maximum concentration (Cmax)
Time frame: 2 months
Time to reach maximum concentration (tmax)
Time frame: 2 months
Trough plasma concentrations (Ctrough)
Time frame: Intensive testing within first 2 months, then every 2 weeks
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
Time frame: 2 months
Mean systemic clearance (CL)
Time frame: 2 months
Clearance at steady state (CLss)
Time frame: 2 months
Accumulation ratio (Rac) on AUC0-14day and Cmax
Time frame: 2 months
Detection of the development of anti-SAR408701 antibody
Time frame: Up to 40 months
Duration of response
Time frame: Up to 40 months - assessment every 6-8 weeks
Time to Progression
Time frame: Up to 40 months - assessment every 6-8 weeks
Results and safety
The study was stopped early (reason given: Sponsor decision, The decision is not related to any safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Results publication: PubMed 35026412Gazzah A, Bedard PL, Hierro C, Kang YK, Abdul Razak A, Ryu MH, Demers B, Fagniez N, Henry C, Hospitel M, Soria JC, Tabernero J. Safety, pharmacokinetics, and antitumor activity of the anti-CEACAM5-DM4 antibody-drug conjugate tusamitamab ravtansine (SAR408701) in patients with advanced solid tumors: first-in-human dose-escalation study. Ann Oncol. 2022 Apr;33(4):416-425. doi: 10.1016/j.annonc.2021.12.012. Epub 2022 Jan 10.
- Results publication: PubMed 37645622Tabernero J, Bedard PL, Bang YJ, Vieito M, Ryu MH, Fagniez N, Chadjaa M, Soufflet C, Masson N, Gazzah A. Tusamitamab Ravtansine in Patients with Advanced Solid Tumors: Phase I Study of Safety, Pharmacokinetics, and Antitumor Activity Using Alternative Dosing Regimens. Cancer Res Commun. 2023 Aug 28;3(8):1662-1671. doi: 10.1158/2767-9764.CRC-23-0284. eCollection 2023 Aug.
- Derived from this study: PubMed 41337813Gazzah A, Ternes N, Lee JS, Wang E, Carene D, Wang H, Masson N, Boitier E, Lartigau A, Mace N, Chadjaa M, Dib C, Nunes M, Muzard G, Longuemaux-Valence S, Bauchet AL. Biomarker analysis from a Phase 1/1b study of tusamitamab ravtansine in patients with advanced non-small cell lung cancer. Transl Oncol. 2026 Jan;63:102615. doi: 10.1016/j.tranon.2025.102615. Epub 2025 Dec 3.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAR408701 in people with Neoplasm Malignant, run by Sanofi at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France, South Korea, Spain, United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision, The decision is not related to any safety concern.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dose limiting adverse events (every 2 week cycle) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02187848, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.