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A Phase I, Open-Label, Multi-Center, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of IMP4297 in Combination With Temozolomide in Patients With Advanced Solid Tumors and Small Cell Lung Cancer
Impact Therapeutics, Inc.
This study will be conducted in two parts. Part 1 (dose escalation) will be undertaken to find the maximum tolerated and/or recommended phase 2 dose (RP2D) of IMP4297 in combination with temozolomide. Part 2 of the study will be conducted in two RP2D expansion cohorts (sensitive ES-Small Cell Lung Cancer (SCLC) cohort and resistant ES-SCLC cohort) to further evaluate the anti-tumour activity, safety and tolerability of this regimen in ES-SCLC patients.