Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582017
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Safety PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A First-in-human Phase 1a1b Study to Evaluate Safety and Tolerability of QXL138AM in Patients With Locally Advanced Un-resectable andor Metastatic Solid Tumors and Multiple Myeloma
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study QXL138AM-001 is a Phase 1a1b study to investigate the safety pharmacokinetics and preliminary activity of QXL138AM in subjects with locally advanced un-resectable andor metastatic solid tumors and multiple myeloma The study is an open-label multicenter first in human study to be conducted in two major parts which are further organized into two sub-parts Part A Dose Escalation is a modified 33 with the first two cohorts consisting of one subject each based on the low clinical starting dose Dose escalation in solid tumors Part A1 will be followed by dose finding in multiple myeloma Part A2 Part B consists of dose expansion in solid tumors Part B1 and multiple myeloma Part B2 using the recommended dose for expansion from Part A
Detailed Description:
This is an open-label multicenter first in human FIH Phase 1a1b study of QXL138AM in participants with locally advanced unresectable andor metastatic solid tumors and multiple myeloma This study will be conducted in two parts A and B and each part has two sub-parts for tumor type 1 and 2
Part A1 - Dose Escalation in Solid Tumors The following solid tumor types will initially be enrolled in this part ovarian pancreatic urothelial renal hepatocellular gastrointestinal lung prostate and breast cancer
Dose escalation will use a standard 33 design where 3 to 6 participants with advanced solid tumors will be enrolled sequentially into each cohortdose level with the exception of Cohort 1 and 2 For Cohorts 1 and 2 given the very low starting dose only one participant is planned for each level unless a participant experiences a Grade 2 or higher adverse event not clearly and incontrovertibly related to disease progression or an extraneous factor If such a Grade 2 or higher event occurs in Cohort 1 or 2 dose escalation will switch to a standard 33 design Dose escalation will continue until the MTD or RDE is determined in participants with solid tumors referred to as the RDE-ST At this point the two solid tumor types for dose expansion will be selected for Part B1 and may begin at the RDE-ST
The proposed dose levels are defined in the table below Cohort No of Participants Dose Level Q2W mgkg
1 1-6 0001
2 1-6 0003
3 3-6 001
4 3-6 003
5 3-6 01
6 3-6 03
7 3-6 1
8 3-6 2
9 3-6 4 Infusions will be administered via syringe pump or IV bag depending on the dose and administered over a 30-60-minute 10 minutes duration
Part A2 - Dose Escalation in Multiple Myeloma Dose escalation in multiple myeloma will commence when the RDE-ST for solid tumors has been identified or if there are signs of anti-tumor activity in Part A1 as determined by the Sponsor
Dose escalation will use a standard 33 design where 3 to 6 participants with multiple myeloma will be enrolled sequentially into dose escalation cohorts starting at one dose level below the RDE-ST determined from solid tumor dose escalation RDE-ST-1 Alternatively if signs of anti-tumor activity in Part A1 are observed the Sponsor may elect to initiate dose escalation in multiple myeloma at one dose level below the highest dose already deemed safe in Part A1 If two of the first six participants in the first multiple myeloma cohort experience a DLT then the dose will be further reduced by one level RDE-ST-2 Once the RDE for multiple myeloma patients is determined it will be referred to as the RDE-MM and dose expansion may begin in patients with multiple myeloma at this dose
Part B1 Dose Expansion in Solid Tumors When the RDE-ST has been identified by the SRC from Part A1 the study may continue to Part B1 dose expansion to further explore the safety and anti-tumor activity of QXL138AM in solid tumors Dose expansion will enroll two cohorts of 20 participants each in two solid tumor indications identified from Part A1 In each cohort patients will be randomized 11 to receive the RDE-ST dose or 1 dose lower The Sponsor may opt to enroll additional participants up to a maximum of 40 in each cohort if signs of anti-tumor activity are observed
Part B2 Dose Expansion in Multiple Myeloma When the RDE-MM in multiple myeloma has been identified by the SRC from Part A2 the study may continue to Part B2 dose expansion to further explore the safety and anti-tumor activity of QXL138AM in patients with multiple myeloma Up to 20 participants will be treated at the RDE-MM identified in Part A2 Patients will be randomized 11 to receive the RDE-MM dose or 1 dose lower
Part A1 - Dose Escalation in Solid Tumors The following solid tumor types will initially be enrolled in this part ovarian pancreatic urothelial renal hepatocellular gastrointestinal lung prostate and breast cancer
Dose escalation will use a standard 33 design where 3 to 6 participants with advanced solid tumors will be enrolled sequentially into each cohortdose level with the exception of Cohort 1 and 2 For Cohorts 1 and 2 given the very low starting dose only one participant is planned for each level unless a participant experiences a Grade 2 or higher adverse event not clearly and incontrovertibly related to disease progression or an extraneous factor If such a Grade 2 or higher event occurs in Cohort 1 or 2 dose escalation will switch to a standard 33 design Dose escalation will continue until the MTD or RDE is determined in participants with solid tumors referred to as the RDE-ST At this point the two solid tumor types for dose expansion will be selected for Part B1 and may begin at the RDE-ST
The proposed dose levels are defined in the table below Cohort No of Participants Dose Level Q2W mgkg
1 1-6 0001
2 1-6 0003
3 3-6 001
4 3-6 003
5 3-6 01
6 3-6 03
7 3-6 1
8 3-6 2
9 3-6 4 Infusions will be administered via syringe pump or IV bag depending on the dose and administered over a 30-60-minute 10 minutes duration
Part A2 - Dose Escalation in Multiple Myeloma Dose escalation in multiple myeloma will commence when the RDE-ST for solid tumors has been identified or if there are signs of anti-tumor activity in Part A1 as determined by the Sponsor
Dose escalation will use a standard 33 design where 3 to 6 participants with multiple myeloma will be enrolled sequentially into dose escalation cohorts starting at one dose level below the RDE-ST determined from solid tumor dose escalation RDE-ST-1 Alternatively if signs of anti-tumor activity in Part A1 are observed the Sponsor may elect to initiate dose escalation in multiple myeloma at one dose level below the highest dose already deemed safe in Part A1 If two of the first six participants in the first multiple myeloma cohort experience a DLT then the dose will be further reduced by one level RDE-ST-2 Once the RDE for multiple myeloma patients is determined it will be referred to as the RDE-MM and dose expansion may begin in patients with multiple myeloma at this dose
Part B1 Dose Expansion in Solid Tumors When the RDE-ST has been identified by the SRC from Part A1 the study may continue to Part B1 dose expansion to further explore the safety and anti-tumor activity of QXL138AM in solid tumors Dose expansion will enroll two cohorts of 20 participants each in two solid tumor indications identified from Part A1 In each cohort patients will be randomized 11 to receive the RDE-ST dose or 1 dose lower The Sponsor may opt to enroll additional participants up to a maximum of 40 in each cohort if signs of anti-tumor activity are observed
Part B2 Dose Expansion in Multiple Myeloma When the RDE-MM in multiple myeloma has been identified by the SRC from Part A2 the study may continue to Part B2 dose expansion to further explore the safety and anti-tumor activity of QXL138AM in patients with multiple myeloma Up to 20 participants will be treated at the RDE-MM identified in Part A2 Patients will be randomized 11 to receive the RDE-MM dose or 1 dose lower
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None