Therapy Detail

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Therapy Name	FLX475 + Pembrolizumab
Synonyms
Therapy Description	FLX475 is a CCR4 antagonist, which may decrease migration of regulatory T-cells into the tumor microenvironment (PMID: 30344896).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
FLX475		FLX-475\|FLX 475		FLX475 is a CCR4 antagonist, which potentially results in increased effector T-cell and decreased regulatory T-cells within the tumor microenvironment, leading to antitumor activity (Journal for ImmunoTherapy of Cancer 2022;10).
Pembrolizumab	Keytruda	MK-3475	Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 124	Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, in combination with chemoradiation for cervical cancer, and in combination with carboplatin and paclitaxel for endometrial carcinoma (FDA.gov).

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT03674567	Phase Ib/II	FLX475 + Pembrolizumab FLX475	Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab	Completed	USA \| AUS	4

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