Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04190628
Status:
TERMINATED
Last Update Posted:
2024-05-21
First Post:
2019-12-03
Brief Title:
Safety and Tolerability of ABM-1310 in Patients With Advanced Solid Tumors
Sponsor:
ABM Therapeutics Corporation
Organization:
ABM Therapeutics Corporation
Study Overview
Official Title:
A Phase I First-In-Human Multicenter Open-Label Dose Escalation and Dose Expansion Study of ABM-1310 as a Monotherapy and a Combination Therapy Administered Orally in Adult Patients With Advanced Solid Tumors Harboring BRAF Mutations
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not related to safety concerns or lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase I First-In-Human open label dose escalation and dose expansion study to evaluate the safety tolerability pharmacokinetics and preliminary anti-cancer activity of ABM-1310 in adult patients with locally advanced or metastatic solid tumors who have no effective standard treatment options available as monotherapy in patients with documented BRAF V600 mutation or in combination with cobimetinib Cotellic in adult patients who have documented BRAF mutation and progressive disease or intolerance to at least one prior line of systemic therapy
Detailed Description:
This is a Phase I First-In-Human open label dose escalation and dose expansion study to evaluate the safety tolerability pharmacokinetics and preliminary anti-cancer activity of ABM-1310 in adult patients with locally advanced or metastatic solid tumors who have no effective standard treatment options available as monotherapy in patients with documented BRAF V600 mutation or in combination with cobimetinib Cotellic in adult patients who have documented BRAF mutation and progressive disease or intolerance to at least one prior line of systemic therapy The primary objectives of this study are to determine the Maximum Tolerated Dose MTD andor the Recommended Phase II Dose RP2D of both single agent and combination treatment and to assess the safety and tolerability of ABM-1310 as a monotherapy and in combination
Study consists of three Parts
Part A The starting dose of ABM-1310 is 25 mg po bid and dose escalation will be guided by a 33 design ABM-1310 will be administered twice daily on a continuous schedule Each treatment cycle consists of 28 days
Part B The starting dose of ABM-1310 will be a dose below the MTD that has been demonstrated to be safe in Part A Monotherapy A classic 33 design will guide the dose escalation At each dose level ABM-1310 will be administered in combination with 60 mg cobimetinib Cotellic once daily qd for the first 21 days of each 28-day treatment cycle
Part C
In C-1 Monotherapy - Primary CNS Tumors and C-2 Monotherapy - Advanced or Metastatic solid tumors excluding Primary CNS tumors with or without Brain Metastasis continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose RP2D from Part A until disease progression unacceptable toxicity or a clinical observation satisfying another withdrawal criterion is met
In C-3 Combination therapy - AdvancedMetastatic Solid Tumors including Primary CNS Tumors but excluding Melanoma with Brain Metastsis and C-4 Combination therapy - Melanoma with Brain Metastasis continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose RP2D from Part B in combination with cobimetinib Cotellic 60 mg administered the first 21 days of each 28-day treatment cycle until disease progression unacceptable toxicity or a clinical observation satisfying another withdrawal criterion is met
Dose limiting toxicity DLT will be evaluated and managed per the pre-defined DLT criteria and rules specified in the protocol MTD andor RP2D will be confirmed in a dose confirmation cohort
Study consists of three Parts
Part A The starting dose of ABM-1310 is 25 mg po bid and dose escalation will be guided by a 33 design ABM-1310 will be administered twice daily on a continuous schedule Each treatment cycle consists of 28 days
Part B The starting dose of ABM-1310 will be a dose below the MTD that has been demonstrated to be safe in Part A Monotherapy A classic 33 design will guide the dose escalation At each dose level ABM-1310 will be administered in combination with 60 mg cobimetinib Cotellic once daily qd for the first 21 days of each 28-day treatment cycle
Part C
In C-1 Monotherapy - Primary CNS Tumors and C-2 Monotherapy - Advanced or Metastatic solid tumors excluding Primary CNS tumors with or without Brain Metastasis continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose RP2D from Part A until disease progression unacceptable toxicity or a clinical observation satisfying another withdrawal criterion is met
In C-3 Combination therapy - AdvancedMetastatic Solid Tumors including Primary CNS Tumors but excluding Melanoma with Brain Metastsis and C-4 Combination therapy - Melanoma with Brain Metastasis continuous twice daily oral doses of ABM-1310 at the recommended phase 2 dose RP2D from Part B in combination with cobimetinib Cotellic 60 mg administered the first 21 days of each 28-day treatment cycle until disease progression unacceptable toxicity or a clinical observation satisfying another withdrawal criterion is met
Dose limiting toxicity DLT will be evaluated and managed per the pre-defined DLT criteria and rules specified in the protocol MTD andor RP2D will be confirmed in a dose confirmation cohort
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