Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310382
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-03-07
Brief Title:
GH55 for Advanced Cancers With MAPK Mutations A Study on Safety and Early Results
Sponsor:
Suzhou Genhouse Bio Co Ltd
Organization:
Suzhou Genhouse Bio Co Ltd
Study Overview
Official Title:
A Phase III Clinical Study Evaluating the Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Antitumor Activity of GH55 in Patients Harboring MAPK Pathway Mutations in Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center open-label dose escalation phase I and dose expansion phase II study aimed to evaluate the safety tolerability PK and PD profiles as well as to observe the efficacy of GH55 in patients with MAPK mutant advanced solid tumors
This study is divided into two parts namely the dose escalation phase I study and the dose expansion phase II study
This study is divided into two parts namely the dose escalation phase I study and the dose expansion phase II study
Detailed Description:
This study is divided into two parts namely the dose escalation phase I study and the dose expansion phase II study This study plans to include 5 dose groups namely 40 mg 80 mg 150 mg 200 mg and 250 mg and adopts a 33 dose escalation design All of the 40 mg 80 mg 150 mg 200 mg and 250 mg groups will adopt the 33 design and 3-6 subjects will be enrolled in each group The enrollment of the first subject and subsequent subject in each dose group should be at least 7 days apart
Subjects will receive a single dose of GH55 on day 1 Cycle 0 Day 1 C0D1 The investigator will assess the safety data on day 3 C0D3 to determine whether subjects can be initiated on multiple doses of GH55 quaque die QD continuously and 3 weeks per cycle on day 4 C1D1 The dose limiting toxicity DLT observation period is from the initiation of single dosing to the end of the first cycle of multiple dosing Cycle 0 3 days and Cycle 1 3 weeks The sponsor and investigator will jointly assess the safety data to determine whether to ascend to the next higher dose These steps will be repeated until MTD is reached and the safety tolerability and PK profile of single dose and multiple doses of oral administration of GH55 will be assessed If MTD cannot be determined when the dose escalation study is complete the sponsor and investigator will jointly determine whether to increase the ascending dose based on the existing safety tolerability PK PD and preliminary efficacy data All subjects can continue the treatment until disease progression initiation of new antitumor treatment withdrawal of informed consent or death whichever occurs first The dose expansion phase II study will begin once the last subject in the dose escalation phase I study has completed the DLT observation Two dose expansion groups will be designed with a dose level in each group that is expected to become the RP2D based on the safety tolerability PKPD profile and preliminary efficacy data of GH55 in the dose escalation phase I study Two dose expansion groups will enroll 60-80 subjects to further evaluate the efficacy safety and PKPD profile of GH55 in patients with advanced solid tumors
Subjects will receive a single dose of GH55 on day 1 Cycle 0 Day 1 C0D1 The investigator will assess the safety data on day 3 C0D3 to determine whether subjects can be initiated on multiple doses of GH55 quaque die QD continuously and 3 weeks per cycle on day 4 C1D1 The dose limiting toxicity DLT observation period is from the initiation of single dosing to the end of the first cycle of multiple dosing Cycle 0 3 days and Cycle 1 3 weeks The sponsor and investigator will jointly assess the safety data to determine whether to ascend to the next higher dose These steps will be repeated until MTD is reached and the safety tolerability and PK profile of single dose and multiple doses of oral administration of GH55 will be assessed If MTD cannot be determined when the dose escalation study is complete the sponsor and investigator will jointly determine whether to increase the ascending dose based on the existing safety tolerability PK PD and preliminary efficacy data All subjects can continue the treatment until disease progression initiation of new antitumor treatment withdrawal of informed consent or death whichever occurs first The dose expansion phase II study will begin once the last subject in the dose escalation phase I study has completed the DLT observation Two dose expansion groups will be designed with a dose level in each group that is expected to become the RP2D based on the safety tolerability PKPD profile and preliminary efficacy data of GH55 in the dose escalation phase I study Two dose expansion groups will enroll 60-80 subjects to further evaluate the efficacy safety and PKPD profile of GH55 in patients with advanced solid tumors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None