A Study of Sacituzumab Govitecan (IMMU-132) in Subjects with Metastatic Solid Tumors
- Conditions
- Metastatic Solid TumorsMedDRA version: 21.1Level: LLTClassification code: 10065147Term: Malignant solid tumor Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-513611-28-00
- Lead Sponsor
- Gilead Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 227
Subjects meeting all the following inclusion criteria at Screening will be eligible for participation in the study. Female or male subjects, > 18 years of age, who are able to understand and give written informed consent., Tumor blocks (preferably obtained within 12 months of study entry if clinically feasible) or 20 newly sectioned unstained slides (6 slides minimum) of archived biopsy/surgical specimens are requested. A baseline biopsy is required if archival tissue is not available. Fine needle aspirates and bone biopsies are not suitable samples. These specimens should be submitted within the 28-day screening period, after the subject provides written informed consent., Subjects with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors. 2.1NSCLC (adenocarcinoma or SCC) that has progressed after prior platinum-based chemotherapy and programmed death-(ligand) 1 (PD- (L)1) directed therapy given sequentially (in either order) or in combination. These agents could have been taken as monotherapy or in combination with other agents. If subjects have had recurrence/relapse or lack of response within 6 months of completing chemotherapy with or without PD-(L)1 directed therapy for locally advanced disease, that line of therapy may be counted for eligibility. 2.2HNSCC that has progressed after prior platinum-based chemotherapy and anti-PD-(L)1 directed therapy given sequentially (in either order) or in combination. These agents could have been taken as monotherapy or in combination with other agents. No more than 3 prior lines of systemic treatment is allowed. 2.3Endometrial carcinoma that has progressed after prior platinum-based chemotherapy and anti- PD-(L)1 directed therapy given sequentially (in either order) or in combination. These agents could have been taken as monotherapy or in combination with other agents. No more than 3 prior lines of systemic treatment is allowed. Endometrial carcinoma with any histology including microsatellite instability-high /mismatch repair deficient and microsatellite stable (MSI-h/dMMR and MSS) are allowed. 2.4Extensive stage SCLC that has progressed after prior platinum-based chemotherapy and PD-(L)1 directed therapy. No more than one prior line of systemic treatment is allowed (re-challenge with the same initial regimen is not allowed)., ECOG Performance Status score of 0 or 1., Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin = 9 g/dL, absolute neutrophil count (ANC) = 1,500/mm3, and platelets = 100,000/µL)., Adequate hepatic function (bilirubin = 1.5 institutional upper limit of normal [IULN], aspartate aminotransferase [AST], and alanine aminotransferase [ALT] = 2.5 × IULN or = 5 × IULN if known liver metastases and serum albumin > 3 g/dL)., Creatinine clearance = 30 mL/min as assessed by Cockcroft-Gault., Subjects must have at least a 3-month life expectancy., Have measurable disease by CT or MRI scan as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area may be utilized if they are considered measurable and PD has been demonstrated in such lesions, Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
Subjects meeting any of the following exclusion criteria at Screening will not be enrolled in the study. Positive serum pregnancy test (Appendix 17.5) or women who are lactating., Have an active infection requiring IV antibiotics., Have positive human immunodeficiency virus (HIV)-1 or HIV-2 antibody with detectable viral load or taking medications that may interfere with SN-38 (the active metabolite of sacituzumab govitecan)., Have active hepatitis B virus (HBV) or hepatitis C virus (HCV), subjects with a detectable viral load will be excluded. 12.1Subjects who test positive for hepatitis B surface antigen (HBsAg). Subjects who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease. 12.2Subjects who test positive for HCV antibody. Subjects who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Subjects with a known history of HCV or a positive HCV antibody test will not require an HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease., Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations., Impending need for palliative radiation therapy or surgery for pathological fractures and/or for medullary compression within 4 weeks prior to initiating study treatment, Additional cohort-specific exclusion criteria:- NSCLC cohort (adenocarcinoma and SCC): 15.1Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of enrollment, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc); any autoimmune, connective tissue, or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren syndrome, sarcoidosis, etc); or prior pneumonectomy. - HNSCC cohort: 15.2Subjects with nasopharynx carcinoma. 15.3Subjects who had progressive disease within 6 months of completion of curative therapy. - Endometrial carcinoma cohort: 15.4Subjects who have carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma, and/or endometrial stromal sarcomas. - Small cell lung cancer cohort: 15.5Subjects who never received platinum-containing regimen for SCLC. 15.6Limited-stage subjects who are candidates for local or regional therapy., Are currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to the first dose of study drug. Subjects participating in observational studies are eligible., Have had a prior anti-cancer biologic agent within 4 weeks prior to study Day 1 or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1., Have not recovered (ie, = Grade 1) from AEs due to a previously administered agent., Have previously received topoisomerase I inhibitors (for SCLC cohort: Etoposide with platinum combination in first-line setting is allowed)., Have an active second malignancy., Have known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may partici
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method