Ignite Creation Date:
2024-05-06 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03526835
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2018-04-04
Brief Title:
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Sponsor:
Merus NV
Organization:
Merus NV
Study Overview
Official Title:
Phase 12 Dose Escalation and Cohort Expansion Study Evaluating MCLA-158 Petosemtamab as Single Agent or in Combination 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 Phase 12 open-label multi-center multi-national study with an initial dose escalation part to determine the recommended Phase II dose RP2D of MCLA-158 single agent in patients with mCRC
The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer mCRC
The study will further assess the safety tolerability PK PD immunogenicity and anti-tumor activity of MCLA-158
The dose escalation part has been completed and the RP2D will be further evaluated in an expansion part of the study Cohorts of selected solid tumor indications for which there is evidence of EGFR dependency and potential sensitivity to EGFR inhibition will be evaluated including head and neck cancer and metastatic colorectal cancer mCRC
The study will further assess the safety tolerability PK PD immunogenicity and anti-tumor activity of MCLA-158
Detailed Description:
Study Design
This open label multicenter first-in-human study consists of 2 parts Part 1 is a dose escalation to find the recommended Phase II dose RP2D of MCLA-158 studying patients with metastatic colorectal cancer mCRC Enrollment in the dose escalation part has been completed
In the dose expansion single-agent cohorts part of the study the activity safety and tolerability of MCLA-158 at 1500 mg every 2 weeks Q2W preliminary RP2D as a single agent will be evaluated in cohorts of selected solid tumor indications with dependency on EGFR signaling The most recently enrolled cohorts were in patients with head and neck squamous cell carcinoma HNSCC Enrollment into the HNSCC cohort of single-agent MCLA-158 for the treatment of patients with secondthird line 2L3L HNSCC is closed Other closed cohort indications included gastricgastroesophageal junction adenocarcinoma GEA with EGFR amplification andor high EGFR expression esophageal carcinoma and pancreatic adenocarcinoma In the dose expansion part of the study safety will also be characterized at two dose levels in this setting
Additionally in the dose expansion combination cohorts part of the study the activity safety and tolerability of MCLA-158 at 1500 mg Q2W will be evaluated in combination with other therapies Enrollment in the combination cohort of treatment of MCLA-158 with pembrolizumab for the treatment of patients with first line 1L HNSCC is closed A second combination cohort of MCLA-158 with FOLFIRI chemotherapy combination ie 5-fluorouracil 5-FU leucovorin and irinotecan FOLFIRI will be explored in mCRC RASRAF wild type patients in the 2L setting Other expansion cohorts may be considered for combination treatment in the future
This open label multicenter first-in-human study consists of 2 parts Part 1 is a dose escalation to find the recommended Phase II dose RP2D of MCLA-158 studying patients with metastatic colorectal cancer mCRC Enrollment in the dose escalation part has been completed
In the dose expansion single-agent cohorts part of the study the activity safety and tolerability of MCLA-158 at 1500 mg every 2 weeks Q2W preliminary RP2D as a single agent will be evaluated in cohorts of selected solid tumor indications with dependency on EGFR signaling The most recently enrolled cohorts were in patients with head and neck squamous cell carcinoma HNSCC Enrollment into the HNSCC cohort of single-agent MCLA-158 for the treatment of patients with secondthird line 2L3L HNSCC is closed Other closed cohort indications included gastricgastroesophageal junction adenocarcinoma GEA with EGFR amplification andor high EGFR expression esophageal carcinoma and pancreatic adenocarcinoma In the dose expansion part of the study safety will also be characterized at two dose levels in this setting
Additionally in the dose expansion combination cohorts part of the study the activity safety and tolerability of MCLA-158 at 1500 mg Q2W will be evaluated in combination with other therapies Enrollment in the combination cohort of treatment of MCLA-158 with pembrolizumab for the treatment of patients with first line 1L HNSCC is closed A second combination cohort of MCLA-158 with FOLFIRI chemotherapy combination ie 5-fluorouracil 5-FU leucovorin and irinotecan FOLFIRI will be explored in mCRC RASRAF wild type patients in the 2L setting Other expansion cohorts may be considered for combination treatment in the future
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-004745-24 | EUDRACT_NUMBER | None | None |