Tusamitamab Ravtansine in NSQ NSCLC Participants With Negative or Moderate CEACAM5 Expression Tumors and High Circulating CEA

Non-squamous Non-small Cell Lung Cancer Clinical Trial

— CARMEN-LC06  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05245071
• Other study ID #: ACT17241
• Secondary ID: U1111-1264-28282
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 1, 2022
• Est. completion date: September 2, 2024

Study information

• Verified date: May 2024
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: September 2, 2024
• Est. primary completion date: March 6, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-squamous Non-small Cell Lung Cancer

Intervention

Drug:
• Tusamitamab ravtansine
Pharmaceutical Form: Concentrate for solution Route of Administration: Intravenous infusion

Locations

Country	Name	City	State
Belgium	Investigational Site Number : 0560003	Edegem
Belgium	Investigational Site Number : 0560001	Leuven
Belgium	Investigational Site Number : 0560002	Liege
France	Investigational Site Number : 2500003	Bordeaux
France	Investigational Site Number : 2500001	Creteil
France	Investigational Site Number : 2500007	Marseille
France	Investigational Site Number : 2500005	Montpellier
France	Investigational Site Number : 2500002	RENNES Cedex 09
France	Investigational Site Number : 2500006	Saint Herblain
France	Investigational Site Number : 2500008	Saint-mande
France	Investigational Site Number : 2500009	Villejuif
Italy	Investigational Site Number : 3800004	Aviano (PN)	Friuli-Venezia Giulia
Italy	Investigational Site Number : 3800002	Milano
Italy	Investigational Site Number : 3800003	Ravenna	Emilia-Romagna
Italy	Investigational Site Number : 3800001	Rozzano	Lombardia
Japan	Investigational Site Number : 3920005	Hirakata-shi	Osaka
Japan	Investigational Site Number : 3920002	Nagoya-shi	Aichi
Japan	Investigational Site Number : 3920001	Sapporo-shi	Hokkaido
Japan	Investigational Site Number : 3920003	Sunto Gun	Shizuoka
Spain	Investigational Site Number : 7240004	Barcelona	Barcelona [Barcelona]
Spain	Investigational Site Number : 7240006	Barcelona	Barcelona [Barcelona]
Spain	Investigational Site Number : 7240001	Hospitalet de Llobregat	Barcelona [Barcelona]
Spain	Investigational Site Number : 7240002	Madrid	Madrid, Comunidad De
Spain	Investigational Site Number : 7240009	Madrid / Madrid	Madrid, Comunidad De
Spain	Investigational Site Number : 7240008	Majadahonda	Madrid
Spain	Investigational Site Number : 7240003	Málaga
Spain	Investigational Site Number : 7240005	Sevilla
Spain	Investigational Site Number : 7240007	Valencia
Turkey	Investigational Site Number : 7920002	Adana
Turkey	Investigational Site Number : 7920005	Ankara
Turkey	Investigational Site Number : 7920003	Istanbul
Turkey	Investigational Site Number : 7920004	Istanbul
Turkey	Investigational Site Number : 7920001	Malatya
United States	Roswell Park Cancer Institute Site Number : 8400004	Buffalo	New York
United States	Renovatio Clinical Site Number : 8400003	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  France,  Italy,  Japan,  Spain,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	Objective Response Rate (ORR), defined as the proportion of participants who have a confirmed complete response (CR) or partial response (PR) as best overall response (BOR) per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1	Baseline up to approximately 9 months after last patient treated
Secondary	Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities	Incidence of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and laboratory abnormalities according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0	Baseline up to approximately 90 days after the last study treatment administration
Secondary	Progression-free survival (PFS)	PFS defined as the time from the date of first tusamitamab ravtansine administration to the date of the first documented disease progression or death due to any cause, whichever comes first.	Baseline up to approximately 9 months after last patient treated
Secondary	Disease control rate (DCR)	DCR defined as the percentage of participants who have achieved confirmed CR or PR, or stable disease as BOR per RECIST v1.1	Baseline up to approximately 9 months after last patient treated
Secondary	Duration of response (DOR)	DOR, defined as the time from first documented evidence of CR or PR until progressive disease (PD) determined per RECIST v1.1 or death from any cause, whichever occurs first	Baseline up to approximately 9 months after last patient treated
Secondary	Incidence of participants with anti-therapeutic antibodies (ATAs) against tusamitamab ravtansine		Baseline up to approximately 30 days after the last study treatment administration