Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05768932
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-01-29
Brief Title:
BAL0891 in Patients With Advanced Solid Tumors
Sponsor:
SillaJen Inc
Organization:
SillaJen Inc
Study Overview
Official Title:
A Phase 1 Study of BAL0891 as Monotherapy and in Combination With Chemotherapy in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-04
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:
This study is a multiple cohort multicenter open-label Phase 1 study with dose-escalation substudies investigating intravenous IV BAL0891 as monotherapy and in combination with carboplatin or paclitaxel to determine the safety and tolerability of increasing doses of BAL0891 in patients with advanced solid tumors An adaptive model-based design will be used to guide the dose escalation Subject assignment to Substudy 1 2 and 3 will be finalized following approval from the investigator and sponsor
The dose-expansion stage will be conducted with the RP2D to further evaluate the preliminary anti-tumor activity safety and tolerability in metastatic TNBC and GC
The dose-expansion stage will be conducted with the RP2D to further evaluate the preliminary anti-tumor activity safety and tolerability in metastatic TNBC and GC
Detailed Description:
Substudy 1 monotherapy dose-escalation cohorts This study will be initiated with enrollment into Substudy 1 and will estimate the safety tolerability PK and PD of increasing doses of BAL0891 in patients with advanced solid tumors The starting dose will be 5 mg based on the GLP Good Laboratory Practice toxicology studies Dose escalation will comprise a dose range from a dose of 5 mg up to a maximum absolute dose of 480 mg with eight nominal dose levels DLs of 5 10 20 40 80 160 320 480 mg Intra-patient dose escalations are only allowed for patients enrolled in single-patient DL Cohorts 11 12 and 13 From DL Cohort 14 onwards the projected maximum dose-escalation factor will be two-fold if the DL cohort investigates an increased dose dosing of the patients within the cohort must be separated by at least 7 days For cohorts in which doses are not increased including backfill enrollment patients may be enrolled concurrently
BAL0891 will be administered intravenously IV on Day D 1 and D8 every 3 weeks Q3W for the schedule of assessments of Regimen A Alternative 21-day or 28-day dosing regimens may be investigated for the schedule of assessments of Regimens B-D
Substudies 2 and 3 dose-escalation cohorts for combination regimens Enrollment into Substudies 2 and 3 may commence as early as first signs of expected target toxicity andor efficacy with Regimen A or an alternative monotherapy regimen have been observed or alternatively once the MTD of BAL0891 monotherapy has been assessed Patients enrolled into Substudies 2 and 3 will be treated with increasing doses of BAL0891 in combination with carboplatin and paclitaxel respectively and dose escalation of both BAL0891 and carboplatinpaclitaxel if required will use the same cumulative BLRM-EWOC model as Substudy 1 The starting dose of BAL0891 in combination with carboplatin or paclitaxel will be a safe DL determined in Substudy 1 but not higher than approximately half the MTD Backfill enrollment of up to a total of 30 additional patients for both substudies who may be enrolled concurrently may be used to better estimate the RP2D for each combination if required
Part 2 Dose expansion The commencement of the dose expansion stage will follow the determination of the RP2D achieved during the dose-escalation phase This stage will consist of four cohorts each comprising 24 patients who have previously undergone at least one systemic regimen for advanced or metastatic disease Specifically two cohorts will be allocated for TNBC investigating BAL0891 both as a monotherapy and in combination with Paclitaxel Additionally two cohorts will be designated for GC investigating the outcomes of BAL0891 as a monotherapy and in combination with Paclitaxel
BAL0891 will be administered intravenously IV on Day D 1 and D8 every 3 weeks Q3W for the schedule of assessments of Regimen A Alternative 21-day or 28-day dosing regimens may be investigated for the schedule of assessments of Regimens B-D
Substudies 2 and 3 dose-escalation cohorts for combination regimens Enrollment into Substudies 2 and 3 may commence as early as first signs of expected target toxicity andor efficacy with Regimen A or an alternative monotherapy regimen have been observed or alternatively once the MTD of BAL0891 monotherapy has been assessed Patients enrolled into Substudies 2 and 3 will be treated with increasing doses of BAL0891 in combination with carboplatin and paclitaxel respectively and dose escalation of both BAL0891 and carboplatinpaclitaxel if required will use the same cumulative BLRM-EWOC model as Substudy 1 The starting dose of BAL0891 in combination with carboplatin or paclitaxel will be a safe DL determined in Substudy 1 but not higher than approximately half the MTD Backfill enrollment of up to a total of 30 additional patients for both substudies who may be enrolled concurrently may be used to better estimate the RP2D for each combination if required
Part 2 Dose expansion The commencement of the dose expansion stage will follow the determination of the RP2D achieved during the dose-escalation phase This stage will consist of four cohorts each comprising 24 patients who have previously undergone at least one systemic regimen for advanced or metastatic disease Specifically two cohorts will be allocated for TNBC investigating BAL0891 both as a monotherapy and in combination with Paclitaxel Additionally two cohorts will be designated for GC investigating the outcomes of BAL0891 as a monotherapy and in combination with Paclitaxel
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