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Therapy Name SKB264
Synonyms
Therapy Description

SKB264 is an antibody-drug conjugate (ADC) composed of a monoclonal antibody that targets trophoblast cell surface protein 2 (TROP2) linked to a topoisomerase I inhibitor, which delivers the drug to TROP2-expressing tumor cells, potentially resulting in antitumor activity (Cancer Res (2024) 84 (7_Supplement): CT038).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
SKB264 SKB 264|SKB-264|ADC SKB264|MK-2870|MK 2870|MK2870|Sacituzumab tirumotecan TROP2 Antibody 18 SKB264 is an antibody-drug conjugate (ADC) composed of a monoclonal antibody that targets trophoblast cell surface protein 2 (TROP2) linked to a topoisomerase I inhibitor, which delivers the drug to TROP2-expressing tumor cells, potentially resulting in antitumor activity (Cancer Res (2024) 84 (7_Supplement): CT038).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT06428409 Phase Ib/II Cisplatin + Pembrolizumab + SKB264 Fluorouracil + Leucovorin + SKB264 SKB264 A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A) Recruiting USA | TUR | ITA | GBR | ESP | CHE | CAN | AUS 5
NCT06074588 Phase III Docetaxel SKB264 Pemetrexed Disodium Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004) Recruiting USA | TUR | POL | ITA | ISR | GRC | GBR | FRA | ESP | DEU | CZE | CAN | BRA | AUS 11
NCT06459180 Phase III Gemcitabine Irinotecan Tisotumab vedotin-tftv Pemetrexed Disodium Vinorelbine Topotecan SKB264 A Study to Compare Sacituzumab Tirumotecan (MK-2870) Monotherapy Versus Treatment of Physician's Choice as Second-line Treatment for Participants With Recurrent or Metastatic Cervical Cancer (MK-2870-020/TroFuse-020/Gog-3101/ENGOT-cx20) Recruiting USA | SWE | POL | NOR | NLD | ITA | ISR | IRL | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CHE | CAN | BRA | BGR | BEL | AUT | AUS | ARG 9
NCT04152499 Phase Ib/II SKB264 Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (A264) Active, not recruiting USA | TUR | CAN 3
NCT05816252 Phase II Osimertinib + SKB264 Carboplatin + SKB264 Carboplatin + Pembrolizumab + SKB264 Pembrolizumab + SKB264 SKB264 A Study of SKB264 (MK-2870; Sac-TMT) for the Treatment of Participants With Advanced or Metastatic Non-small Cell Lung Cancer (SKB264-II-04) (MK-2870-003) Active, not recruiting TUR | ROU | ESP 3
NCT06637423 Phase Ib/II SKB264 A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Patients With Bladder Cancer (MK-2870-027) (TroFuse-027) Recruiting USA | NLD | GBR | FRA | ESP | CAN 0
NCT06356311 Phase III Trifluridine-tipiracil hydrochloride Irinotecan Paclitaxel Docetaxel SKB264 A Study to Evaluate Sacituzumab Tirumotecan (MK-2870) in Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-2870-015) (TroFuse-015) Recruiting USA | TUR | POL | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CAN | BRA | BEL 11
NCT06305754 Phase III Carboplatin + Pemetrexed Disodium SKB264 Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) and Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) Recruiting USA | TUR | SWE | POL | ITA | FRA | ESP | CAN | ARG 10
NCT06132958 Phase III Paclitaxel Doxorubicin Nab-paclitaxel SKB264 Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005) (TroFuse-005) Active, not recruiting USA | SWE | POL | NOR | NLD | ITA | ISR | IRL | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | ARG 8
NCT06952504 Phase III Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab SKB264 Carboplatin + Docetaxel + Pembrolizumab Pembrolizumab + SKB264 A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29) (TroFuse-033) Recruiting USA | SWE | POL | NOR | NLD | ITA | ISR | IRL | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG 10
NCT06841354 Phase III Carboplatin + Gemcitabine Carboplatin + Nab-paclitaxel Pembrolizumab + SKB264 SKB264 Carboplatin + Paclitaxel A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011) Recruiting USA | ROU | POL | NZL | NLD | ITA | ISR | HUN | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUS | ARG 11
NCT06824467 Phase III SKB264 Bevacizumab + SKB264 Bevacizumab A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103) Recruiting USA | ESP | AUS 3


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