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This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer.

The purpose of this study is to test study treatments that combine an investigational drug (tucatinib, which is also known as ONT-380) (the “study drug”) with two approved drugs (capecitabine and trastuzumab) in participants with advanced breast cancer to find out what effects, good or bad, it may have on the participants and their disease.

KEYNOTE-799: A phase 2 trial of pembrolizumab (mk-3475), in combination with platinum doublet chemotherapy and radiotherapy, for participants with unresectable, locally advanced stage III non-small cell lung cancer (NSCLC)

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy before surgery (neoadjuvant phase), followed by pembrolizumab alone after surgery (adjuvant phase) in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC).

PANTHER: A phase 3, randomized, controlled, open-label, clinical study of pevonedistat plus azacitidine vs. single-agent azacitidine as first-line treatment for patients with higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), or low-blast acute myelogenous leukemia (AML)