A Study to Evaluate the Safety and Pharmacokinetics of the Intravenous Fixed-Dose Combination (IV FDC) of Tiragolumab and Atezolizumab in Participants With Locally Advanced, Recurrent or Metastatic Solid Tumors (SKYSCRAPER-11)
- Conditions
- Solid TumorsTherapeutic area: Diseases [C] - Neoplasms [C04]MedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104
- Registration Number
- CTIS2023-508489-14-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 63
Histologic documentation of locally advanced, recurrent, or metastataic malignancy ineligible for definitive local therapy, for which a clinical trial of an investigational agent in combination with an anti-PD-L1 antibody is considered an acceptable treatment option., Adequate hematologic and end organ function, PD-L1-selected tumors, as determined by the investigational VENTANA® PD-L1 (SP263) IHC assay. Tumor types include: EAC, ESCC, GC, GEJ, HCC, melanoma, NSCLC, RCC, SCCHN, and UBC., Measurable disease per RECIST v1.1, Life expectancy =12 weeks
Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of tiragolumab and atezolizumab IV FDC, Prior treatment with CPIs including but not limited to anti-TIGIT, anti-PD-L1, anti-PD-1, anti-CTLA-4, Primary central nervous system (CNS) malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control), Malignancies other than disease under study within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ), Acute infection and/or treatment with systemic antibiotics within 4 weeks of first dose, Any other diseases, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or may render the participant at high risk from treatment complications
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of tiragolumab and atezolizumab intravenous (IV) fixed-dose combination (FDC);Secondary Objective: To characterize the pharmacokinetics of tiragolumab and atezolizumab following administration of IV FDC, To evaluate the immune response to tiragolumab and atezolizumab following IV FDC administration by measuring anti-tiragolumab and anti-atezolizumab antibodies;Primary end point(s): 1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0) – The severity of CRS will also be determined according to the ASTCTCRS American Society for Transplantation and Cellular Therapy cytokine release syndrome Consensus Grading Scale.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):1. Area under the concentration time curve of tiragolumab and atezolizumab at Cycle 1;Secondary end point(s):2. Maximum serum concentration (Cmax) of tiragolumab and atezolizumab at Cycle 1;Secondary end point(s):3. Minimum serum concentration (Cmin) of tiragolumab and atezolizumab at Cycle 1;Secondary end point(s):4. Prevalence of anti-drug antibodies (ADAs) to tiragolumab at baseline and the incidence of treatment emergent ADAs to tiragolumab during the study;Secondary end point(s):5. Prevalence of ADAs to atezolizumab at baseline and the incidence of treatment emergent ADAs to atezolizumab during the study