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Experimental drug targets Hard-to-Treat cancers in new trial

NCT ID NCT04659603

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a drug called tusamitamab ravtansine, alone or with chemotherapy (gemcitabine), in 50 people with advanced breast or pancreatic cancers that have a specific marker (CEACAM5). The goal was to see if the drug could shrink tumors. The study was terminated early, so full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tusamitamab ravtansine (an antibody-drug conjugate) and gemcitabine (a chemotherapy drug)
What this could lead to
If successful, this could point toward a new treatment option for people with certain advanced breast or pancreatic cancers that express the CEACAM5 marker.
What could go wrong
This early-phase trial was terminated, so results are limited. The drug may cause serious side effects like low blood cell counts or eye problems, and it is unclear if it will work better than existing therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

50 people

The number who actually took part.

Started

Mar 2021

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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. Exclusion Criteria: 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 * 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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma malignant pancreatic neoplasm metastatic carcinoma pancreatic adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer, metastatic Pancreatic carcinoma metastatic

Contacts and locations

Locations

  • AdventHealth Orlando Site Number : 8400001

    Orlando, Florida, 32804, United States

  • Investigational Site Number : 0320001

    Pergamino, Buenos Aires, B2700CPM, Argentina

  • Investigational Site Number : 0320002

    Rosario, Santa Fe Province, 2000, Argentina

  • Investigational Site Number : 0320003

    Capital Federal, Buenos Aires, 1012, Argentina

  • Investigational Site Number : 1520001

    Santiago, Reg Metropolitana de Santiago, 8420383, Chile

  • Investigational Site Number : 1520002

    Temuco, La Araucanía, 4800827, Chile

  • Investigational Site Number : 1520003

    Santiago, Reg Metropolitana de Santiago, 7500921, Chile

  • Investigational Site Number : 1580001

    Taichung, 40447, Taiwan

  • Investigational Site Number : 1580002

    Tainan, 704, Taiwan

  • Investigational Site Number : 1580003

    Taipei, 11217, Taiwan

  • Investigational Site Number : 3480003

    Budapest, 1122, Hungary

  • Investigational Site Number : 4100001

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number : 4100002

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number : 4100003

    Goyang-si, Gyeonggi-do, 10408, South Korea

  • Investigational Site Number : 5280001

    Rotterdam, 3015 GD, Netherlands

  • Investigational Site Number : 5280002

    Amsterdam, 1066 CX, Netherlands

  • Investigational Site Number : 5280003

    Utrecht, 3584 CX, Netherlands

  • Investigational Site Number : 6430001

    Moscow, 115478, Russia

  • Investigational Site Number : 6430002

    Saint Petersburg, 197758, Russia

  • Investigational Site Number : 6430004

    Pushkin, Saint- Petersburg, 196603, Russia

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240002

    Majadahonda, Madrid, 28222, Spain

  • Investigational Site Number : 7240003

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Investigational Site Number : 7920001

    Istanbul, 34722, Turkey (Türkiye)

  • Investigational Site Number : 7920002

    Izmir, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Adana, 01250, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    Ankara, 06100, Turkey (Türkiye)

  • Massachusetts General Hospital Site Number : 8400002

    Boston, Massachusetts, 02114, United States

  • University of Wisconsin Site Number : 8400004

    Madison, Wisconsin, 53792, United States

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