Esophageal Cancer Clinical Trial
Basket Study to Evaluate the Therapeutic Activity of Simlukafusp Alfa as a Combination Therapy in Participants With Advanced and/or Metastatic Solid Tumors
This is an open-label, multicenter, basket trial Phase II study to evaluate the antitumor activity of simlukafusp alfa in combination with atezolizumab in participants with advanced and/or metastatic solid tumors. Currently the focus is on patients with Head and Neck, oesophageal and cervical cancers with confirmed squamous cell carcinoma histology type.
Participants who have progressed on at least one previous regimen of anticancer therapy (chemotherapy, mutation targeted therapy, and/or CPI therapy)
Measurable disease, as defined by RECIST Version 1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or Karnofsky Performance Score greater than or equal to (>=) 70
Life expectancy of >=12 weeks
Confirmed at least one tumor lesion with location accessible to safely biopsy per clinical judgment of the treating physician.
Biopsies are not applicable to participants in Cohorts G, H, K, and L presenting with a single target lesion and absence of any non-target lesion.
Consent to provide an archival tumor tissue sample (if available, applicable to all participants)
Willingness to undergo baseline and on-treatment tumor biopsies for pharmacodynamics (PD) biomarker analysis (biopsies are optional for Cohort A)
Adequate cardiovascular function as defined in the study protocol
AEs related to any previous radiotherapy, chemotherapy, or surgical procedure must have resolved to Grade less than or equal to (<=) 1, except alopecia (any grade) and Grade 2 peripheral neuropathy
Adequate haematological, liver, and renal functions.
Participants with unilateral pleural effusion (indications other than NSCLC) are eligible if they fulfill both of the following:
NYHA Class 1
Forced expiratory volume 1 (FEV1) and forced vital capacity (FVC) >70% of predicted value; participants with lung metastases should present with DLCO >60% of predicted value.
Participants with Gilbert's syndrome will be eligible for the study
Participants must have had confirmed diagnosis of recurrent or metastatic squamous cell carcinoma head and neck, or esophageal cancer or metastatic, persistent or recurrent squamous cervical cancer.
Symptomatic or untreated central nervous system (CNS) metastases
History of treated asymptomatic CNS metastases as described in the protocol
Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=2 weeks before enrollment
An active second malignancy
Penetrating tumor infiltration
Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
Episode of significant cardiovascular/cerebrovascular acute disease within 6 months before study treatment administration
History of significant vascular disease (for example, aortic aneurysm, aortic dissection)
Active or uncontrolled infections
Human immunodeficiency virus (HIV) or Active Hepatitis A, B, C, D or E infection (HAV/HBV/HCV/HDV/HEV).
Severe infection within 4 weeks before study treatment administration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
History of chronic liver disease or evidence of hepatic cirrhosis
Dementia or altered mental status that would prohibit informed consent
History of, active or suspicion of autoimmune disease
History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia (bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
Bilateral pleural effusion confirmed by X-ray
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding that give reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug
Concurrent therapy with any other investigational drug
Immunomodulating agents as described in study protocol
Chronic use of steroids
Last dose with any cytostatic treatments < 28 days before study treatment administration
Radiotherapy within the last 4 weeks before start of study treatment administration, with the exception of limited field palliative radiotherapy
Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1 or at any time during the study and 5 months after the last dose of atezolizumab
Major surgery or significant traumatic injury <28 days before study treatment administration (excluding fine needle biopsies) or if wound healing has not completed after surgery or anticipation of the need for major surgery during study treatment
Known hypersensitivity to any of the components of the simlukafusp alfa drug product or atezolizumab drug product
Severe dyspnea at rest or requiring supplementary oxygen therapy Locally curative options are available for participant's disease.
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There are 43 Locations for this study
San Francisco California, 94158, United States
Newnan Georgia, 30265, United States
Edegem , 2650, Belgium
Gent , 9000, Belgium
Leuven , 3000, Belgium
Bordeaux , 33076, France
Marseille , 13385, France
Montpellier cedex 5 , 34298, France
Villejuif , 94805, France
Essen , 45147, Germany
Haifa , 31096, Israel
Seongnam-si , 13620, Korea, Republic of
Seoul , 003-7, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 135-7, Korea, Republic of
Auckland , 1023, New Zealand
Gda?sk , 80-21, Poland
Warszawa , 02-78, Poland
Moscow , 10522, Russian Federation
Saint-Petersburg , 19775, Russian Federation
Singapore , 11922, Singapore
Singapore , 16961, Singapore
Pamplona Navarra, 31008, Spain
Barcelona , 08003, Spain
Barcelona , 08035, Spain
Madrid , 28027, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Valencia , 46010, Spain
Geneve , 1211, Switzerland
Tainan , 704, Taiwan
Taipei , 100, Taiwan
Adana , 01120, Turkey
Antalya , 07070, Turkey
Edirne , 22030, Turkey
Istanbul , 34098, Turkey
Izmir , , Turkey
Kadiköy , 34722, Turkey
London , EC1M6, United Kingdom
London , N7 9N, United Kingdom
Manchester , M2O 4, United Kingdom
Sutton , SM2 5, United Kingdom
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