Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
Study to Assess Adverse Events and How Intravenously IV Infused ABBV-400 Moves Through the Body of Adult Participants With Unresectable Locally AdvancedMetastatic Colorectal Cancer
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 1b Study to Evaluate Safety and Pharmacokinetics PK of ABBV-400 in Chinese Subjects With Unresectable Locally AdvancedMetastatic Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Colorectal cancer CRC is the third most common type of cancer diagnosed worldwide and in China The purpose of this study is to assess adverse events and how ABBV-400 moves through the body of adult participants with unresectable locally advancedmetastatic CRC
ABBV-400 is an investigational drug being developed for the treatment of CRC Study doctors put the participants in cohorts called treatment arms Each treatment arm receives a different dose of ABBV-400 This study will include a dose escalation phase to determine the best dose of ABBV-400 followed by a dose expansion phase to confirm the dose Up to approximately 27 adult participants with unresectable locally advancedmetastatic CRC will be enrolled in the study in approximately 10 sites in China
In the dose escalation arms participants will receive escalating doses of intravenously IV infused ABBV-400 dose A or B In dose expansion arm part 1 participants will receive the optimal dose of IV infused ABBV-400 In dose expansion arm part 2 participants will receive the dose B of IV infused ABBV-400 The total study duration will be approximately 25 years
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at an approved institution hospital or clinic The effect of the treatment will be frequently checked by medical assessments blood tests questionnaires and side effects
ABBV-400 is an investigational drug being developed for the treatment of CRC Study doctors put the participants in cohorts called treatment arms Each treatment arm receives a different dose of ABBV-400 This study will include a dose escalation phase to determine the best dose of ABBV-400 followed by a dose expansion phase to confirm the dose Up to approximately 27 adult participants with unresectable locally advancedmetastatic CRC will be enrolled in the study in approximately 10 sites in China
In the dose escalation arms participants will receive escalating doses of intravenously IV infused ABBV-400 dose A or B In dose expansion arm part 1 participants will receive the optimal dose of IV infused ABBV-400 In dose expansion arm part 2 participants will receive the dose B of IV infused ABBV-400 The total study duration will be approximately 25 years
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at an approved institution hospital or clinic The effect of the treatment will be frequently checked by medical assessments blood tests questionnaires and side effects
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None