Spots Global Cancer Trial Database for A Phase I Study of RGT-264 in Subjects With Advanced Solid Tumors

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Trial Identification

Brief Title: A Phase I Study of RGT-264 in Subjects With Advanced Solid Tumors

Official Title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of RGT-264 Phosphate Tablets in Subjects With Advanced Solid Tumors

Study ID: NCT05764915

Conditions

Advanced Solid Tumor

Interventions

RGT-264 phosphate tablets

Study Description

Brief Summary: This is a Phase 1 dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of RGT-264 as monotherapy in subjects with advanced solid tumors.

Detailed Description: This first-in-human (FIH) study of RGT-264 will evaluate safety, pharmacokinetics (PK) and efficacy of RGT-264 in subjects with advanced solid tumors. The primary objective is to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended phase II dose (RP2D) of RGT-264 as monotherapy, and to evaluate the safety and tolerability of RGT-264. The secondary objectives include the assessments of PK profile and preliminary efficacy of RGT-264.