Relapsed or Refractory Delta-Like Protein 3-Expressing Small Cell Lung Cancer MedDRA version: 19.0 Level: PT Classification code 10041070 Term: Small cell lung cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10070308 Term: Refractory cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Rovalpituzumab Tesirine
Product Code: SC16LD6.5
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Rovalpituzumab tesirine
Current Sponsor code: SC16LD6.5
Other d
Sponsors
Stemcentrx Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult aged 18 years or older 2. Histologically confirmed small-cell lung cancer (SCLC) with documented disease progression after at least 2 prior systemic regimens, including at least one platinum-based regimen 3. DLL3-expressing SCLC based on central immunohistochemistry (IHC) assessment of banked or otherwise representative tumor tissue. Positive is defined as staining in = 1% of tumor cells. 4. Measurable disease, defined as at least 1 tumor lesion =10 mm in the longest diameter or a lymph node =15 mm in short-axis measurement assessed by CT scan (RECIST v1.1) 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Minimum life expectancy of at least 12 weeks 7. Subjects with a history of central nervous system (CNS) metastases must have documentation of stable or improved status based on brain imaging for at least 2 weeks after completion of definitive treatment and within 2 weeks prior to first dose of Study Drug, off or on a stable dose of corticosteroids. Definitive treatment may include surgical resection, whole brain irradiation, and/or stereotactic radiation therapy 8. Recovery to Grade 1 of any clinically significant toxicity (excluding alopecia) prior to initiation of study drug administration 9. Satisfactory laboratory parameters: a. Absolute neutrophil count (ANC) = 1,500/µL b. Platelet count = 75,000/µL c. Hemoglobin = 8.0 g/dL d. Serum total bilirubin = 1.5X upper limit of normal (ULN) or = 3X ULN for subjects with Gilbert’s disease e. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5X ULN (= 5X ULN if evidence of hepatic involvement by malignant disease) f. Serum creatinine = 1.5X ULN or estimated glomerular filtration rate (eGFR) = 30 mL/min/1.73m^2 as calculated by the 4-variable Modification of Diet in Renal Disease (MDRD) study equation (GFR (mL/min/1.73 m^2) = 175 × (serum creatinine [mg/dL])–1.154 × (age [years])–0.203 × 0.742 (if female) × 1.212 (if African American) 10. Last dose of any prior therapy administered by the following time intervals before the first dose of study drug: a. Chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies): 2 weeks b. Immune-checkpoint inhibitors (i.e., anti-PD-1, anti-PD-L1, or anti- CTLA-4): 4 weeks c. Other monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies: 4 weeks (2 weeks with documented disease progression) 11. Females of childbearing potential must have a negative beta human chorionic gonadotropin (ß-hCG) pregnancy test result within 7 days prior to the first dose of study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. a. Females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraception method during the study and for 1 year following the last dose of study drug. Effective birth control includes (a) combined, estrogen and progestogen containing, hormonal contraception (oral, intravaginal, transdermal); (b) progestogen-only hormonal contraception (oral, injectable, implantable); (c) intrauterine device; (d) intrataurine hormone-releasing system; (e) bilateral tubal occlusion; (f) vasectomised partner; and (g) sexual abstinence. Are the trial subjects under 18? no Number of subjects for this ag
Exclusion criteria
Exclusion criteria: 1. Any significant medical condition, including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study, including but not necessarily limited to uncontrolled hypertension and/or diabetes, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease requiring hospitalization within 6 months) or neurological disorder (e.g., seizure disorder active within 6 months) 2. Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III–IV (see Appendix 0) within 6 months prior to their first dose of study drug 3. Recent or ongoing serious infection, including: a. Any active grade 3 or higher (per NCI CTCAE version 4.03) viral, bacterial, or fungal infection within 2 weeks of the first dose of the study drug. Routine antimicrobial prophylaxis is permitted. b. Known seropositivity for or active infection by human immunodeficiency virus (HIV) c. Active Hepatitis B (by surface antigen expression or polymerase chain reaction) or Hepatitis C (by polymerase chain reaction) infection or on hepatitis-related antiviral therapy within 6 months of first dose of study drug. 4. Women who are breastfeeding 5. Systemic therapy with corticosteroids at >20 mg/day prednisone or equivalent within 1 week prior to the first dose of study drug 6. History of another invasive malignancy that has not been in remission for at least 3 years. Exceptions to the 3 year limit include nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical cancer in situ on biopsy or squamous intraepithelial lesion on PAP smear 7. Prior exposure to a pyrrolobenzodiazepine (PBD)-based drug, or known hypersensitivity to rovalpituzumab tesirine or excipient contained in the drug formulation, unless undergoing retreatment with rovalpituzumab tesirine in the context of this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of rovalpituzumab tesirine as third-line and later treatment for subjects with relapsed or refractory delta-like protein 3 (DLL3)-expressing small cell lung cancer (SCLC);Secondary Objective: - To assess duration of response, clinical benefit rate and progression-free survival in subjects with relapsed or refractory DLL3-expressing SCLC treated with rovalpituzumab tesirine - To assess the safety and tolerability of rovalpituzumab tesirine - To characterize the pharmacokinetics of rovalpituzumab tesirine and incidence of anti-therapeutic antibodies (ATA);Primary end point(s): - Objective response rate through the End of Treatment for subjects with an IHC assessment that is = 50% positive and for subjects with an IHC assessment that is = 1% positive - Overall survival for subjects with an IHC assessment that is = 50% positive and for subjects with an IHC assessment that is = 1% positive;Timepoint(s) of evaluation of this end point: (42 ± 3 days after last dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Clinical Benefit Rate 2. Duration of response 3. Progression-free survival;Timepoint(s) of evaluation of this end point: 1. Duration of clinical benefit is defined as the number of weeks from the start date of PR, CR or SD (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. 2. Duration of response is defined as the number of weeks from the start date of PR or CR (whichever response is recorded first) and subsequently confirmed to the first date that recurrent or progressive disease or death is documented. 3. Progression-free survival is defined as the number of weeks from first dose date (Day 1) to the date of earliest date of PD or death due to any cause. | — |
Countries
France, Germany, Hungary, Poland, Spain, United States
Contacts
Public ContactRegulatory Affairs
Stemcentrx Inc.
Outcome results
None listed