Spots Global Cancer Trial Database for A Phase I Clinical Trial of FWD1802 in Patients With ER+/HER2- BC.

Study Description

Brief Summary: This is a phase I open-label dose escalation trial of FWD1802 as monotherapy and in combination with palbociclib in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer The goal of this clinical trial\] is to learn about in ER+/HER2- BC participant population. The main questions it aims to answer are: * Establish the recommended phase II dose (RP2D) and/or the maximum tolerated dose (MTD) of FWD1802 as monotherapy and in combination with palbociclib in patients with ER+/HER2- unresectable locally advanced or metastatic breast cancer. * Explore the safety and tolerability of FWD1802 as monotherapy and in combination with Palbociclib. * Characterise Pharmacokinetics of FWD1802 as monotherapy and in combination with palbociclib. * Explore preliminary efficacy signals.

Detailed Description: This is a multiple cohort study, an initial dose escalation phase is designed to confirm the safe dose of FWD1802 as monotherapy and in combination with Palbociclib. A Safety Monitoring Committee (SMC) will monitor the safety, tolerability, and PK data during this phase. Once ascertained, an expansion cohort will be opened to explore the efficacy of FWD1802 as monotherapy and in combination with Palbociclib. Part A is an open-label, dose escalation of FWD 1802 as monotherapy . Dose escalation steps will be determined by the Safety Monitoring Committee (SMC), based on 3+3 rule except for the accelerated escalation on the 1st dose level. With pharmacokinetic (PK), pharmacodynamics (PD), efficacy and safety data, SMC will evaluate to guide determination of potentially effective dose for part B and C. Part B is an open-label, dose escalation of FWD 1802 in combination with palbociclib fixed dose. Dose escalation steps will be determined by SMC, based on 3+3 rule. With PK, PD, efficacy and safety data, SMC will evaluate to guide determination of potentially effective combination dose. Part C is an open label , dose expansion of FWD 1802 monotherapy on patients with ER+/HER2-/ESR1 mutation, no more than 2 dose levels will be evaluated, with 30 patients at the most in either dose level cohort.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

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