Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513067
Status:
TERMINATED
Last Update Posted:
2023-12-08
First Post:
2020-08-11
Brief Title:
A Safety Study of YQ23 in Advanced Solid Tumors Patients
Sponsor:
New Beta Innovation Limited
Organization:
New Beta Innovation Limited
Study Overview
Official Title:
A Phase Ib Open-label Dose-escalation Study of YQ23 as a Single Agent and in Combination With Pembrolizumab Administered to Patients With Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to business decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an early phase dose escalation study which is divided into two stages 1 Single agent of the test drug YQ23 and 2 in combination with pembrolizumab administered to patients with advanced solid tumors
The purpose of the study is find out the safety and tolerability profile as well as maximum tolerated dose MTD of YQ23 as single agent stage 1 and in combination with pembrolizumab stage 2 Stage 2 will start only when the MTD of single agent YQ23 has been established in Stage 1
The distribution of YQ23 in the blood the tumor response to YQ23 and pembrolizumab in stage 2 the change of some pre-defined biomarkers in the tumor tissues and blood and the change of antibody response and its relationship with the disease response safety and drug level in the blood will also be evaluated
In stage 1 eligible patients will be given intravenous infusion of YQ23 weekly for 6 weeks In stage 2 eligible patients will be also be given a fixed dose of pembrolizumab 200 mg on Day 1 and every 3 weeks thereafter in addition to the weekly dose of YQ23 Dose escalation decision will be made based on the safety data available for the 6 weeks study treatments
Patients may continue study treatments beyond 6 weeks if she tolerates the study drugs well the disease does not get worse after first 6 doses and meet all treatment continuation criteria as judged by the study doctor
The purpose of the study is find out the safety and tolerability profile as well as maximum tolerated dose MTD of YQ23 as single agent stage 1 and in combination with pembrolizumab stage 2 Stage 2 will start only when the MTD of single agent YQ23 has been established in Stage 1
The distribution of YQ23 in the blood the tumor response to YQ23 and pembrolizumab in stage 2 the change of some pre-defined biomarkers in the tumor tissues and blood and the change of antibody response and its relationship with the disease response safety and drug level in the blood will also be evaluated
In stage 1 eligible patients will be given intravenous infusion of YQ23 weekly for 6 weeks In stage 2 eligible patients will be also be given a fixed dose of pembrolizumab 200 mg on Day 1 and every 3 weeks thereafter in addition to the weekly dose of YQ23 Dose escalation decision will be made based on the safety data available for the 6 weeks study treatments
Patients may continue study treatments beyond 6 weeks if she tolerates the study drugs well the disease does not get worse after first 6 doses and meet all treatment continuation criteria as judged by the study doctor
Detailed Description:
This is a phase 1b open-label dose-finding study to primarily evaluate the safety and tolerability and MTD of YQ23 as a single agent and when in combination with pembrolizumab combo therapy in patients with advanced malignant solid tumors of which it will have the potential to benefit from immunotherapy such as triple negative breast cancer colorectal cancer liver cancer non-small cell lung cancer or renal cell carcinoma In the study the Pharmacokinetics PK profile and the disease response to YQ23 will be investigated while the Pharmacodynamics PDx profile and immunogenicity of YQ23 will be explored when YQ23 is given alone and in combo therapy
The study composes of 2 stages Stage 1 is a YQ23 alone dose escalation study and Stage 2 is YQ23 in combination with pembrolizumab dose escalation study The primary objective of the study is to establish the MTD of YQ23 as a single agent and the MTD when given in combination with pembrolizumab by evaluating the incidence of dose-limiting toxicities DLT
In Stage 1 trial subjects will be enrolled successively in the treatment cohorts of 5 dose levels of YQ23 Each subject will receive an intravenous fixed dose of YQ23 weekly in one of the treatment cohorts Stage 2 will start only when the MTD of single agent YQ23 has been established in Stage 1 In Stage 2 trial subjects will be enrolled successively in combo therapy dose cohorts starting with the lowest tested dose of YQ23 up to the MTD established in Stage 1 In each cohort of Stage 2 a fixed dose of 200 mg pembrolizumab will be given every 3 weeks on the same day following YQ23 administration
Dose escalation decision will be made by an Independent Data Safety Monitoring Committee DSMC as determined by the DLT which is based on the incidence and intensity of drug-related adverse events toxicities occurring up to 5 days after the administration of the sixth dose of YQ23 in the single and combo therapy The toxicities will be graded by the National Cancer Institute Common Toxicity Criteria for Adverse Events CTCAE v50
At least 3 evaluable subjects will be treated per dose cohort Evaluable subjects are defined as subjects who have completed the first 6 doses of YQ23 and the safety assessment at Day 6 post YQ23 Dose 6 or subjects who have discontinued treatment due to a DLT Dose escalation will only be started after all subjects in the previous cohort have completed assessments at Day 6 post Dose 6 of YQ23 in the single and combo therapy dose escalations A satisfactory review of the safety and tolerability data by the DSMC is required before any dose escalation
Following a 33 design the MTD is defined as the highest dose level at which six patients are treated and one DLT has been observed or three patients are treated and no one has experienced a DLT If no DLT is found the highest dose will be determined as the MTD
The study composes of 2 stages Stage 1 is a YQ23 alone dose escalation study and Stage 2 is YQ23 in combination with pembrolizumab dose escalation study The primary objective of the study is to establish the MTD of YQ23 as a single agent and the MTD when given in combination with pembrolizumab by evaluating the incidence of dose-limiting toxicities DLT
In Stage 1 trial subjects will be enrolled successively in the treatment cohorts of 5 dose levels of YQ23 Each subject will receive an intravenous fixed dose of YQ23 weekly in one of the treatment cohorts Stage 2 will start only when the MTD of single agent YQ23 has been established in Stage 1 In Stage 2 trial subjects will be enrolled successively in combo therapy dose cohorts starting with the lowest tested dose of YQ23 up to the MTD established in Stage 1 In each cohort of Stage 2 a fixed dose of 200 mg pembrolizumab will be given every 3 weeks on the same day following YQ23 administration
Dose escalation decision will be made by an Independent Data Safety Monitoring Committee DSMC as determined by the DLT which is based on the incidence and intensity of drug-related adverse events toxicities occurring up to 5 days after the administration of the sixth dose of YQ23 in the single and combo therapy The toxicities will be graded by the National Cancer Institute Common Toxicity Criteria for Adverse Events CTCAE v50
At least 3 evaluable subjects will be treated per dose cohort Evaluable subjects are defined as subjects who have completed the first 6 doses of YQ23 and the safety assessment at Day 6 post YQ23 Dose 6 or subjects who have discontinued treatment due to a DLT Dose escalation will only be started after all subjects in the previous cohort have completed assessments at Day 6 post Dose 6 of YQ23 in the single and combo therapy dose escalations A satisfactory review of the safety and tolerability data by the DSMC is required before any dose escalation
Following a 33 design the MTD is defined as the highest dose level at which six patients are treated and one DLT has been observed or three patients are treated and no one has experienced a DLT If no DLT is found the highest dose will be determined as the MTD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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