Clinical trial NCT05245071: Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Official title: Open-label, Phase 2 Study, Evaluating the Efficacy and Safety of Tusamitamab Ravtansine in Non-squamous Non-small-cell Lung Cancer (NSQ NSCLC) Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Non-squamous Non-small Cell Lung Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2022-02-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open label single group, Phase 2, 1-arm study for treatment to evaluate efficacy, safety, and Pharmacokinetic (PK) of tusamitamab ravtansine in nonsquamous non-small-cell-lung-cancer (NSQ NSCLC) participants with negative or moderate CEACAM5 expression tumors and high circulating carcinoembryonic antigen (CEA).

Participants who will be enrolled, will receive tusamitamab ravtansine as monotherapy every two weeks (Q2W) until disease progression, unacceptable adverse event (AE), initiation of a new anticancer therapy, or the participant's or investigator's decision to stop the treatment, whichever comes first. A total of approximately 38 participants are planned to be treated.

Detailed description: 40 weeks (up to 4 weeks for screening, a median of 24 weeks for treatment, and a median of 12 weeks for end of treatment assessments and the safety follow-up visit).

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically proven diagnosis of NSQ NSCLC metastatic disease at study entry; progression after platinum-based chemotherapy and immune checkpoint inhibitor.
* Participants with moderate or negative CEACAM5 expression as demonstrated prospectively by central laboratory via immune histochemistry (ICH) and high circulating CEA levels (≥100 ng/mL). Moderate CEACAM5 expression is defined as intensity ≥ 2 + in ≥ 1% and \<50 % of tumor cells. Negative CEACAM5 expression is defined as intensity of 1 + whatever the percentage of stained tumor cells or \<1% of tumor cells.
* At least one measurable lesion by RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
* Women of childbearing potential or male patient with women of childbearing potential who agree to use highly effective method of birth control.

Exclusion Criteria:

* Patients with untreated brain metastases or history of leptomeningeal disease.
* 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 uncontrolled infection with human immunodeficiency virus (HIV), or unresolved viral hepatitis
* Significant concomitant illness that could impair the participation in the study or interpretation of the results or any major surgery with 3 weeks prior treatment administration
* Nonresolution 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.
* Previous history of and/or unresolved corneal disorders. The use of contact lenses is not permitted.
* Prior treatment with maytansinoid derivatives (DM1 or DM4 antibody drug conjugate) or any drug targeting CEACAM5.
* Concurrent treatment with any other anticancer therapy
* Poor bone marrow, liver or kidney functions.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
Secondary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
timeFrame: From first dose of study treatment (Day 1) up to primary completion date (06-Mar-2024), approximately 21 months
measure: Progression-Free Survival (PFS)
timeFrame: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
measure: Disease Control Rate (DCR)
timeFrame: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
measure: Duration of Response (DOR)
timeFrame: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute Site Number : 8400004
state: New York
city: El Paso
country: United States
facility: Renovatio Clinical Site Number : 8400003
state: Texas
city: Edegem
country: Belgium
facility: Investigational Site Number : 0560003
city: Leuven
country: Belgium
facility: Investigational Site Number : 0560001
city: Liege
country: Belgium
facility: Investigational Site Number : 0560002
city: Bordeaux
country: France
facility: Investigational Site Number : 2500003
city: Creteil
country: France
facility: Investigational Site Number : 2500001
city: Marseille
country: France
facility: Investigational Site Number : 2500007
city: Montpellier
country: France
facility: Investigational Site Number : 2500005
city: RENNES Cedex 09
country: France
facility: Investigational Site Number : 2500002
city: Saint Herblain
country: France
facility: Investigational Site Number : 2500006
city: Saint-mande
country: France
facility: Investigational Site Number : 2500008
city: Villejuif
country: France
facility: Investigational Site Number : 2500009
city: Ravenna
country: Italy
facility: Investigational Site Number : 3800003
state: Emilia-Romagna
city: Aviano (PN)
country: Italy
facility: Investigational Site Number : 3800004
state: Friuli-Venezia Giulia
city: Rozzano
country: Italy
facility: Investigational Site Number : 3800001
state: Lombardia
city: Milano
country: Italy
facility: Investigational Site Number : 3800002
city: Nagoya-shi
country: Japan
facility: Investigational Site Number : 3920002
state: Aichi
city: Sapporo-shi
country: Japan
facility: Investigational Site Number : 3920001
state: Hokkaido
city: Hirakata-shi
country: Japan
facility: Investigational Site Number : 3920005
state: Osaka
city: Sunto Gun
country: Japan
facility: Investigational Site Number : 3920003
state: Shizuoka
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240004
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Investigational Site Number : 7240006
state: Barcelona [Barcelona]
city: Hospitalet de Llobregat
country: Spain
facility: Investigational Site Number : 7240001
state: Barcelona [Barcelona]
city: Madrid / Madrid
country: Spain
facility: Investigational Site Number : 7240009
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Investigational Site Number : 7240002
state: Madrid, Comunidad De
city: Majadahonda
country: Spain
facility: Investigational Site Number : 7240008
state: Madrid
city: Málaga
country: Spain
facility: Investigational Site Number : 7240003
city: Sevilla
country: Spain
facility: Investigational Site Number : 7240005
city: Valencia
country: Spain
facility: Investigational Site Number : 7240007
city: Adana
country: Turkey
facility: Investigational Site Number : 7920002
city: Ankara
country: Turkey
facility: Investigational Site Number : 7920005
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920003
city: Istanbul
country: Turkey
facility: Investigational Site Number : 7920004
city: Malatya
country: Turkey
facility: Investigational Site Number : 7920001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: