Targeted Treatment of Advanced Solid Tumors Based on Molecular Tumor Profiles (Basket of Baskets)

Solid tumors are cancers that, unlike blood cancers, form solid masses of tissue (tumors) in organs or tissues. In some tumors, the cancer cells carry specific changes in their genetic material (known as mutations) that can contribute to the tumor’s growth. The Basket-of-Baskets study is a so-called basket study in which patients are selected and assigned to an appropriate treatment not based on the type of their tumor, but rather on the genetic changes in the tumor tissue. The study is divided into two parts: First, the tumor tissue is examined in the laboratory for cancer-relevant genetic changes (molecular profile); then, patients receive targeted therapy that matches the changes identified. This treatment is divided into several modules. In one module, the drug atezolizumab is administered as an intravenous infusion. In another module, the drug futibatinib is taken as a tablet, and in a third module, the drug amivantamab is administered as an intravenous infusion. Atezolizumab is a so-called immune checkpoint inhibitor (an anti-PD-L1 antibody); it blocks the PD-L1 protein and can thus help the body’s own immune system recognize cancer cells and fight them. Futibatinib is specifically used to treat tumors with mutations in the FGFR genes; these genes contain the blueprint for the FGFR receptors, proteins on the cell surface that transmit growth signals. Amivantamab is an antibody that targets the EGFR and MET receptors and can therefore attack tumors with alterations in these two genes. Depending on the genetic mutation, patients are assigned to the appropriate module and study arm. This is a single-arm study with only one treatment group; patients are not assigned randomly (non-randomized). The study is open-label (not blinded), which means that both patients and study physicians know which medication is being administered.

Patients aged 18 and older with an advanced solid tumor that has spread as metastases or is inoperable—and that has progressed after standard therapy or for which no standard therapy is available—are eligible to participate. Patients who are ineligible include, among others, those with untreated or unstable brain metastases, certain severe comorbidities (such as heart failure), or active infections such as HIV or hepatitis B or C.