Description:
The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline treatment of small cell lung cancer (SCLC).
The purpose of the study is to test the effect of rovalpituzumab tesirine in the frontline treatment of small cell lung cancer (SCLC).
Terminated
Phase 1
Drug | Synonyms | Arms |
---|---|---|
Rovalpituzumab Tesirine | SC16LD6.5 | Rovalpituzumab Tesirine |
Cisplatin | Rovalpituzumab Tesirine followed by Cisplatin, Etoposide | |
Etoposide | Rovalpituzumab Tesirine followed by Cisplatin, Etoposide |
Name | Type | Description | Interventions |
---|---|---|---|
Rovalpituzumab Tesirine | Experimental | Rovalpituzumab Tesirine 0.3 mg/kg IV infusion |
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Rovalpituzumab Tesirine followed by Cisplatin, Etoposide | Experimental | Rovalpituzumab Tesirine 0.3 mg/kg IV infusion followed by Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion |
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Rovalpituzumab Tesirine with Cisplatin, Etoposide | Experimental | Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion and Rovalpituzumab Tesirine 0.1 mg/kg IV infusion |
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Rovalpituzumab Tesirine following Cisplatin, Etoposide | Experimental | Cisplatin 80 mg/m2 and Etoposide 100 mg/m2 IV infusion followed by Rovalpituzumab Tesirine 0.3 mg/kg IV infusion |
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Inclusion Criteria: - Age ≥ 18 years with histologically- or cytologically-confirmed, extensive-stage, chemotherapy-naïve SCLC - DLL3-expressing SCLC based on central immunohistochemistry (IHC) assessment. Positive is defined as staining in ≥75% of tumor cells. - Eastern Cooperative Oncology Group performance status of 0 or 1. - Minimum life expectancy of at least 12 weeks. - Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug. - Satisfactory laboratory parameters within defined parameters (ANC, platelet count, Hb, total bilirubin, ALT, AST and GFR) - Subjects with a history of CNS metastases must have completed definitive treatment prior to first dose of study treatment, off or on a stable dose of corticosteroids - Use of effective contraception method during and for 1 year following study drug dosing if female of childbearing potential or sexually active male Exclusion Criteria: - Prior systemic chemotherapy, small molecule inhibitors, immune checkpoint inhibitors, other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, T-cell or other cell-based or biologic therapies, or any other anticancer therapy for the treatment of (limited or extensive) SCLC. - Any significant medical condition, that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study. - Documented history of a cerebral vascular, unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to their first dose of study drug. - Recent or ongoing serious infection. - Women who are pregnant or breastfeeding. - History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear. - Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Dose limiting toxicities (DLT) of rovalpituzumab tesirine when administered as monotherapy, in series or in combination with frontline chemotherapy to subjects with DLL3 expressing extensive-stage small cell lung cancer (SCLC) |
Time Frame: | within 21 days after first dose of rovalpituzumab tesirine |
Safety Issue: | |
Description: | For Phase 1a |
Measure: | Best overall response rate |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Duration of response (DOR) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Clinical Benefit Rate (CBR) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Overall Survival (OS) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Incidence of anti-therapeutic antibodies (ATAs) against rovalpituzumab tesirine |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Progression-free survival (Phase 1a) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Pharmacokinetic parameters: Cmax (Maximum plasma concentration observed ) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Pharmacokinetic parameters: AUC0-tau (Area under the plasma concentration-time curve within a dosing interval) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Pharmacokinetic parameters: AUC0-∞ (Area under the curve from time 0 extrapolated to infinity) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Pharmacokinetic parameters: Tmax (Time of Cmax) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Pharmacokinetic parameters: Ctrough (Observed plasma concentrations at trough) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Pharmacokinetic parameters: T1/2 (Terminal half-life) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Pharmacokinetic parameters: CL (Clearance) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Pharmacokinetic parameters: Vss (Volume of distribution at steady state) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Incidence of TEAEs |
Time Frame: | 4 years |
Safety Issue: | |
Description: | For Phase 1b |
Measure: | Changes in vital signs (Heart Rate) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Changes in vital signs (Blood pressure) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Changes in vital signs (Temperature) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Changes in vital signs (Weight) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Changes in vital signs (Respirations) |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Measure: | Eastern Cooperative Oncology Group (ECOG) score |
Time Frame: | 4 years |
Safety Issue: | |
Description: |
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Terminated |
Lead Sponsor: | AbbVie |
March 12, 2020