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
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Sanofi
- Enrollment
- 22
- Locations
- 35
- Primary Endpoint
- Objective Response Rate (ORR)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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 CEACAM
- •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
Arms & Interventions
Tusamitamab ravtansine
Tusamitamab ravtansine dose will be administered on Day 1 via IV infusion and repeated once every 2 weeks. The duration of 1 cycle will be 14 days (1 administration of tusamitamab ravtansine per cycle).
Intervention: Tusamitamab ravtansine (Drug)
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks
The ORR was defined as percentage of participants with confirmed complete response (CR) or partial response (PR) as best overall response (BOR) determined per Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. The CR was defined as disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 millimeters (mm). The 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.
Secondary Outcomes
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)(From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 84 weeks)
- Progression-Free Survival (PFS)(Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks)
- Disease Control Rate (DCR)(Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks)
- Duration of Response (DOR)(Tumor assessments performed at baseline, and every 8 weeks +/-7 days thereafter, approximately 46 weeks)