Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid Tumors

Stopped early · Phase 2

Conditions studied: Breast Cancer Metastatic, Pancreatic Carcinoma Metastatic

In brief

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

Key facts

Study ID

NCT04659603

Run by

Sanofi

People needed

50

Starts

2021-03-29

Expected to finish

2025-01-19

Last updated by the study team

2025-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• AdventHealth Orlando Site Number : 8400001 — Orlando, Florida, United States
• Massachusetts General Hospital Site Number : 8400002 — Boston, Massachusetts, United States
• University of Wisconsin Site Number : 8400004 — Madison, Wisconsin, United States
• Investigational Site Number : 0320003 — Capital Federal, Buenos Aires, Argentina
• Investigational Site Number : 0320001 — Pergamino, Buenos Aires, Argentina
• Investigational Site Number : 0320002 — Rosario, Santa Fe Province, Argentina
• Investigational Site Number : 1520002 — Temuco, La Araucanía, Chile
• Investigational Site Number : 1520003 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 1520001 — Santiago, Reg Metropolitana de Santiago, Chile
• Investigational Site Number : 3480003 — Budapest, Hungary
• Investigational Site Number : 5280002 — Amsterdam, Netherlands
• Investigational Site Number : 5280001 — Rotterdam, Netherlands
• Investigational Site Number : 5280003 — Utrecht, Netherlands
• Investigational Site Number : 6430001 — Moscow, Russia
• Investigational Site Number : 6430004 — Pushkin, Saint- Petersburg, Russia
• Investigational Site Number : 6430002 — Saint Petersburg, Russia
• Investigational Site Number : 4100003 — Goyang-si, Gyeonggi-do, South Korea
• Investigational Site Number : 4100001 — Seoul, Seoul-teukbyeolsi, South Korea
• Investigational Site Number : 4100002 — Seoul, Seoul-teukbyeolsi, South Korea
• Investigational Site Number : 7240001 — Barcelona, Barcelona [Barcelona], Spain
• Investigational Site Number : 7240002 — Majadahonda, Madrid, Spain
• Investigational Site Number : 7240003 — Madrid, Madrid, Comunidad de, Spain
• Investigational Site Number : 1580001 — Taichung, Taiwan
• Investigational Site Number : 1580002 — Tainan, Taiwan
• Investigational Site Number : 1580003 — Taipei, Taiwan

Full record on ClinicalTrials.gov

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