Breast Cancer MetastaticPhase 2CARMEN-BT01NCT04659603
Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors
A Phase 2 study testing tusamitamab ravtansine and Gemcitabine in people with Breast Cancer Metastatic and Pancreatic Carcinoma Metastatic, run by Sanofi at 29 sites in 10 countries.
Trial summary
Primary Objective: For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine monotherapy and in combination with gemcitabine in metastatic pancreatic adenocarcinoma (mPAC) For Cohort C Part 1: Confirmation of the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Metastatic, Pancreatic Carcinoma Metastatic
- What is being tested?
- tusamitamab ravtansine and Gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 29 sitesin 10 countries
- Study dates
- 29 Mar 2021to 19 Jan 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participant must be at least 18 years of age
- Participants with at least one measurable lesion according to the RECIST v1.1 criteria that has not been irradiated (ie, newly arising lesions in previously irradiated areas are accepted).
- Participants with ECOG performance status 0 to 1.
- Evidence of metastatic disease.
- Expression of CEACAM 5 by centrally assessed IHC assay.
- Male and female participants willing to comply with contraceptive use consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Show all 15Show fewer
- Cohort A: mBC
- Histological or cytologic diagnosis of breast cancer.
- Have received at least 2 prior cytotoxic chemotherapy regimens for non-TNBC tumor type or at least 1 for TNBC tumor type but not more than 4 in the locally recurrent or metastatic setting.
- Cohorts B and C: mPAC
- Have confirmed diagnosis of pancreatic ductal adenocarcinoma.
- Cohort B: mPAC:
- Have documented radiographic progression or documented intolerance after at least 1 prior systemic chemotherapy line which included either gemcitabine (or relapsed within 6 months of completion of gemcitabine adjuvant therapy) or a 5-fluorouracil based regimen (including capecitabine) but no more than 2 prior chemotherapy lines for locally advanced/metastatic disease.
- Cohort C: mPAC
- Have documented radiographic progression or documented intolerance after 1st line fluoropyrimidine-containing chemotherapy (or relapsed within 6 months of completion of chemotherapy as adjuvant therapy) for locally advanced/metastatic disease.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Medical condition requiring concomitant administration of a medication with a narrow therapeutic window, that is metabolized by cytochrome P450 (CYP450), 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 the first administration of study intervention.
- Life expectancy less than 3 months.
- Untreated brain metastases or history of leptomeningeal disease.
- Significant concomitant illness
Show all 23Show fewer
- History within the last 3 years of an invasive malignancy other than the one treated in this study, with the exception of resected/ablated basal or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix, or other local tumors considered cured by local treatment.
- History of known acquired immunodeficiency syndrome (AIDS) related illnesses or known human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or active hepatitis A, B or C infection.
- Non-resolution of any prior treatment-related toxicity to <Grade 2 according to NCI CTCAE v5.0, with the exception of alopecia, vitiligo, or active thyroiditis controlled with hormone replacement therapy (HRT).
- Unresolved corneal disorder or any previous corneal disorder considered by an ophthalmologist to predict higher risk of drug-induced keratopathy.
- Use of contact lenses. Participants using contact lenses who are not willing to stop wearing them for the duration of the study intervention are excluded.
- Concurrent treatment with any other anti cancer therapy.
- Washout period before the first administration of study intervention of less than 3 weeks or less than 5 times the half-life, whichever is shorter, for prior antitumor therapy (chemotherapy, targeted agents, immunotherapy and radiotherapy, or any investigational treatment).
- Any prior therapy targeting CEACAM5.
- Prior maytansinoid DM4 treatment (ADC).
- Any major surgery within the preceding 2 weeks of the first study intervention administration.
- Previous enrollment in this study or current participation in any other clinical study involving an investigational study treatment or any other type of medical research.
- Poor renal function
- Poor hepatic function
- Poor bone marrow function
- Cohort C: mPAC
- Any previous systemic therapy with taxane or gemcitabine (for Cohort C only).
- The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.
Trial locations and contacts
29 sites in 10 countries.
29 sites in 10 countries
Turkey (Türkiye)4 sites
Investigational Site Number : 7920003
Adana, 01250
Investigational Site Number : 7920004
Ankara, 06100
Investigational Site Number : 7920001
Istanbul, 34722
Investigational Site Number : 7920002
Izmir
United States3 sites
Massachusetts General Hospital Site Number : 8400002
Boston, Massachusetts, 02114
University of Wisconsin Site Number : 8400004
Madison, Wisconsin, 53792
AdventHealth Orlando Site Number : 8400001
Orlando, Florida, 32804
Argentina3 sites
Investigational Site Number : 0320003
Capital Federal, Buenos Aires, 1012
Investigational Site Number : 0320001
Pergamino, Buenos Aires, B2700CPM
Investigational Site Number : 0320002
Rosario, Santa Fe Province, 2000
Chile3 sites
Investigational Site Number : 1520003
Santiago, Reg Metropolitana de Santiago, 7500921
Investigational Site Number : 1520001
Santiago, Reg Metropolitana de Santiago, 8420383
Investigational Site Number : 1520002
Temuco, La Araucanía, 4800827
Netherlands3 sites
Investigational Site Number : 5280002
Amsterdam, 1066 CX
Investigational Site Number : 5280001
Rotterdam, 3015 GD
Investigational Site Number : 5280003
Utrecht, 3584 CX
Russia3 sites
Investigational Site Number : 6430001
Moscow, 115478
Investigational Site Number : 6430004
Pushkin, Saint- Petersburg, 196603
Investigational Site Number : 6430002
Saint Petersburg, 197758
South Korea3 sites
Investigational Site Number : 4100003
Goyang-si, Gyeonggi-do, 10408
Investigational Site Number : 4100001
Seoul, Seoul-teukbyeolsi, 03080
Investigational Site Number : 4100002
Seoul, Seoul-teukbyeolsi, 06351
Spain3 sites
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], 08035
Investigational Site Number : 7240003
Madrid, Madrid, Comunidad de, 28046
Investigational Site Number : 7240002
Majadahonda, Madrid, 28222
Taiwan3 sites
Investigational Site Number : 1580001
Taichung, 40447
Investigational Site Number : 1580002
Tainan, 704
Investigational Site Number : 1580003
Taipei, 11217
About this study
Official title: Open-label, Multi-cohort, Phase 2 Trial, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine (SAR408701) Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors
Primary Objective:
- For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine monotherapy and in combination with gemcitabine in metastatic pancreatic adenocarcinoma (mPAC)
- For Cohort C Part 1: Confirmation of the recommended tusamitamab ravtansine dose when administered in combination with gemcitabine
Read more
Secondary Objectives:
- To assess the safety and tolerability of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine
- To assess other efficacy parameters of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine
- To assess the immunogenicity of tusamitamab ravtansine
- To assess the pharmacokinetics (PK) of tusamitamab ravtansine and gemcitabine when given in combination
Read the detailed description
The expected duration of study intervention for participants may vary, based on progression date and the cohort; median expected duration of study per participant is estimated at 8 months for Cohort A/C and 6 months for Cohort B (up to 1 month for screening, a median of 4 or 2 months for treatment in Cohort A/C and Cohort B respectively, a median of 1 month for EOT, and follow-up visit 90 days after the last IMP administration).
- Being tested
- tusamitamab ravtansine, Gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tusamitamab ravtansineDrug
Also called SAR408701
Pharmaceutical form:Concentrated solution for IV;
Route of administration: IV infusion
GemcitabineDrug
Pharmaceutical form: Lyophilized powder for reconstitution or as a solution for infusion;
Route of administration: IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Cohort A metastatic breast cancer (mBC) | Experimental | tusamitamab ravtansine every 2 weeks administered via intravenous infusion (IV) Receives: Drug: tusamitamab ravtansine |
| Cohort B metastatic pancreatic adenocarcinoma (mPAC) | Experimental | tusamitamab ravtansine every 2 weeks administered via intravenous infusion (IV) Receives: Drug: tusamitamab ravtansine |
| Cohort C Metastatic pancreatic adenocarcinoma (mPAC) | Experimental | tusamitamab ravtansine every 2 weeks combined with gemcitabine on Day 1, Day 8 and Day 15 every 4 weeks administered via intravenous infusion (IV) Receives: Drug: tusamitamab ravtansine; Drug: Gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR was defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Measured: From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)
Cohort C (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)
The following adverse events (AEs) that occurred during the first cycle of treatment, unless due to disease progression or to a cause obviously unrelated to study treatment, were considered DLTs:
- Hematological abnormalities: grade 4 neutropenia for 7 or more consecutive days, grade 3 to 4 neutropenia complicated by fever or microbiologically or radiographically documented infection, grade greater than or equal to (≥) 3 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention;
- Non-hematological abnormalities: grade 4 non-hematologic AE, grade ≥3 keratopathy.
In addition, any other AE that the recruiting Investigators and Sponsor deemed to be dose limiting, regardless of its grade, was also considered as DLT.
Measured: Cycle 1 (28 days)
Secondary outcomes (10)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An AE was defined as any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A serious adverse event was defined as any AE that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission of any infectious agent via an authorized medicinal product. TEAEs were defined as AEs that developed, worsened, or became serious during the treatment-emergent period (defined as the period from the first study treatment administration to the last study treatment administration + 30 days).
Measured: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 86.6 weeks
Number of Participants With Laboratory Abnormalities: Hematology/Coagulation and Clinical Chemistry
Blood samples were collected to determine the abnormalities in hematology/coagulation and clinical chemistry. Abnormality criteria was assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Events v5.0. Hematological and coagulation parameters assessed were white blood cells, platelets, neutrophils, lymphocytes, and international normalized ratio. Clinical chemistry parameters assessed were albumin, sodium, potassium, calcium, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and total bilirubin. Only those categories in which at least 1 participant had >2 grade worsening in laboratory abnormalities are reported.
Measured: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 86.6 weeks
Progression-free Survival (PFS)
PFS was defined as the time from the date of first tusamitamab ravtansine administration to the date of the first documented disease progression according to RECIST v1.1 or death due to any cause, whichever came first. Disease progression was defined as unequivocal progression of existing non-target lesions; at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)
Disease Control Rate (DCR)
DCR was defined as the percentage of participants who achieved confirmed CR, confirmed PR or stable disease (SD) as per RECIST v1.1. CR was defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum of diameters while on study.
Measured: From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)
Duration of Response (DOR)
DOR was defined as the time from first documented evidence of confirmed CR or confirmed PR until progressive disease determined per RECIST v1.1 or death from any cause, whichever occurred first. CR was defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. Disease progression was defined as unequivocal progression of existing non-target lesions; at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Measured: From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)
Number of Participants With Treatment-emergent Anti-therapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine
Blood samples were collected for assessing the presence of ATA against tusamitamab ravtansine in plasma. The number of participants with treatment-emergent ATA i.e., either seroconverted (treatment-induced ATAs) or boosted their pre-existing ATA response (treatment-boosted ATAs) during the study are reported.
Measured: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration [maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)]
Cohort C: Maximum Concentration Observed After Infusion (Cmax) of Tusamitamab Ravtansine
Blood samples were collected for the measurement of Cmax of tusamitamab ravtansine. Cmax was calculated using non-compartmental method.
Measured: Cycle 1: Day 1: Start of infusion, end of infusion, 3, 72, 168, and 336 hours post-start of infusion (cycle duration: 28 days)
Cohort C: Area Under the Plasma Concentration Versus Time Curve Calculated Using the Trapezoidal Method From Time 0 to 14 Days (AUC0-14d) of Tusamitamab Ravtansine
Blood samples were collected for the measurement of AUC0-14d of tusamitamab ravtansine. AUC0-14d was calculated using non-compartmental method.
Measured: Cycle 1: Day 1: Start of infusion, end of infusion, 3, 72, 168, and 336 hours post-start of infusion (cycle duration: 28 days)
Cohort C: Total Body Clearance From Plasma (CL) of Gemcitabine
Blood samples were collected for the measurement of CL of gemcitabine. CL was calculated using non-compartmental method.
Measured: Cycle 1: Days 1 and 8: Start of infusion, end of infusion, 0.25, 1, 1.5, and 2 hours post-start of infusion (cycle duration: 28 days)
Cohort C: Cmax of Gemcitabine Metabolite (dFdU)
Blood samples were collected for the measurement of Cmax of dFdU. Cmax was calculated using non-compartmental method.
Measured: Cycle 1: Days 1 and 8: Start of infusion, end of infusion, 0.25, 1, 1.5, and 2 hours post-start of infusion (cycle duration: 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start29 Mar 2021
- Primary completion16 Feb 2024
- Study completion19 Jan 2025
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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer MetastaticStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT04659603
- Sponsor's protocol ID
- ACT16432
- Other IDs
- U1111-1244-1644, 2020-003096-18
- Acronym
- CARMEN-BT01
- Status last verified
- Sep 2025
- First submitted
- 2 Dec 2020
- Last updated
- 1 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Multi-cohort, Phase 2 Trial, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine (SAR408701) Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04659603
- Acronym / sponsor ID
- CARMEN-BT01 / ACT16432
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision, the decision is not related to any safety concern.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 19 Jan 2025 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Posted 25 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objective:
- For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine monotherapy and in combination with gemcitabine in metastatic pancreatic adenocarcinoma (mPAC)
- For Cohort C Part 1: Confirmation of the recommended tusamitamab ravtansine dose when administered in combination with gemcitabine
Secondary Objectives:
- To assess the safety and tolerability of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine
- To assess other efficacy parameters of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine
- To assess the immunogenicity of tusamitamab ravtansine
- To assess the pharmacokinetics (PK) of tusamitamab ravtansine and gemcitabine when given in combination
Detailed description
The expected duration of study intervention for participants may vary, based on progression date and the cohort; median expected duration of study per participant is estimated at 8 months for Cohort A/C and 6 months for Cohort B (up to 1 month for screening, a median of 4 or 2 months for treatment in Cohort A/C and Cohort B respectively, a median of 1 month for EOT, and follow-up visit 90 days after the last IMP administration).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A metastatic breast cancer (mBC) | Experimental | Drug: tusamitamab ravtansinetusamitamab ravtansine every 2 weeks administered via intravenous infusion (IV) |
| Cohort B metastatic pancreatic adenocarcinoma (mPAC) | Experimental | Drug: tusamitamab ravtansinetusamitamab ravtansine every 2 weeks administered via intravenous infusion (IV) |
| Cohort C Metastatic pancreatic adenocarcinoma (mPAC) | Experimental | Drug: tusamitamab ravtansine, Drug: Gemcitabinetusamitamab ravtansine every 2 weeks combined with gemcitabine on Day 1, Day 8 and Day 15 every 4 weeks administered via intravenous infusion (IV) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participant must be at least 18 years of age
- Participants with at least one measurable lesion according to the RECIST v1.1 criteria that has not been irradiated (ie, newly arising lesions in previously irradiated areas are accepted).
- Participants with ECOG performance status 0 to 1.
- Evidence of metastatic disease.
- Expression of CEACAM 5 by centrally assessed IHC assay.
Key exclusion criteria (23 listed)
- Medical condition requiring concomitant administration of a medication with a narrow therapeutic window, that is metabolized by cytochrome P450 (CYP450), 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 the first administration of study intervention.
- Life expectancy less than 3 months.
- Untreated brain metastases or history of leptomeningeal disease.
- Significant concomitant illness
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 |
|---|---|---|
| tusamitamab ravtansineAlso: SAR408701Pharmaceutical form:Concentrated solution for IV; Route of administration: IV infusion | Drug | Cohort A metastatic breast cancer (mBC), Cohort B metastatic pancreatic adenocarcinoma (mPAC), Cohort C Metastatic pancreatic adenocarcinoma (mPAC) |
| GemcitabinePharmaceutical form: Lyophilized powder for reconstitution or as a solution for infusion; Route of administration: IV infusion | Drug | Cohort C Metastatic pancreatic adenocarcinoma (mPAC) |
Primary outcome
Objective Response Rate (ORR)
Time frame: From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)
ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. CR was defined as disappearance of all target and non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Cohort C (Part 1): Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (28 days)
The following adverse events (AEs) that occurred during the first cycle of treatment, unless due to disease progression or to a cause obviously unrelated to study treatment, were considered DLTs: 1. Hematological abnormalities: grade 4 neutropenia for 7 or more consecutive days, grade 3 to 4 neutropenia complicated by fever or microbiologically or radiographically documented infection, grade greater than or equal to (≥) 3 thrombocytopenia associated with clinically significant bleeding requiring clinical intervention; 2. Non-hematological abnormalities: grade 4 non-hematologic AE, grade ≥3 keratopathy. In addition, any other AE that the recruiting Investigators and Sponsor deemed to be dose limiting, regardless of its grade, was also considered as DLT.
10 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Time frame: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 86.6 weeks
Number of Participants With Laboratory Abnormalities: Hematology/Coagulation and Clinical Chemistry
Time frame: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment, approximately 86.6 weeks
Progression-free Survival (PFS)
Time frame: From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)
Disease Control Rate (DCR)
Time frame: From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)
Duration of Response (DOR)
Time frame: From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)
Number of Participants With Treatment-emergent Anti-therapeutic Antibodies (ATAs) Against Tusamitamab Ravtansine
Time frame: From date of first study treatment administration (Day 1) up to 30 days after the last dose of study treatment administration [maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)]
Cohort C: Maximum Concentration Observed After Infusion (Cmax) of Tusamitamab Ravtansine
Time frame: Cycle 1: Day 1: Start of infusion, end of infusion, 3, 72, 168, and 336 hours post-start of infusion (cycle duration: 28 days)
Cohort C: Area Under the Plasma Concentration Versus Time Curve Calculated Using the Trapezoidal Method From Time 0 to 14 Days (AUC0-14d) of Tusamitamab Ravtansine
Time frame: Cycle 1: Day 1: Start of infusion, end of infusion, 3, 72, 168, and 336 hours post-start of infusion (cycle duration: 28 days)
Cohort C: Total Body Clearance From Plasma (CL) of Gemcitabine
Time frame: Cycle 1: Days 1 and 8: Start of infusion, end of infusion, 0.25, 1, 1.5, and 2 hours post-start of infusion (cycle duration: 28 days)
Cohort C: Cmax of Gemcitabine Metabolite (dFdU)
Time frame: Cycle 1: Days 1 and 8: Start of infusion, end of infusion, 0.25, 1, 1.5, and 2 hours post-start of infusion (cycle duration: 28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ACT16432 Plain Language Results SummaryLink provided by the sponsor.
- 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
Related trials for Breast Cancer Metastatic
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
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
29 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tusamitamab ravtansine and Gemcitabine in people with Breast Cancer Metastatic and Pancreatic Carcinoma Metastatic, run by Sanofi at 29 sites in 10 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 15 inclusion and 23 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Turkey (Türkiye), United States, Argentina, Chile, Netherlands and 5 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate (ORR) (time frame: From date of first study treatment administration (Day 1) up to maximum exposure of treatment: 26.1 weeks (Cohort A), 51.6 weeks (Cohort B), 43.3 weeks (Cohort C)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2025.