Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05721222
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-01-31
Brief Title:
PRO1160 for Advanced Solid and Liquid Tumors PRO1160-001
Sponsor:
ProfoundBio US Co
Organization:
ProfoundBio US Co
Study Overview
Official Title:
Phase 12 Study of PRO1160 in Patients With Renal Cell Carcinoma RCC Nasopharyngeal Carcinoma NPC or Non-Hodgkin Lymphoma NHL
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Brief Summary
This study will test the safety including side effects and determine the characteristics of a drug called PRO1160 in participants with solid tumors
Participants will have solid tumor or liquid cancer that has spread through the body metastatic or cannot be removed with surgery unresectable
This Phase 12 study will have two parts Part A of the study will find out how much and how frequently PRO1160 should be given to participants Part B will use the dose and schedule found in Part A to find out how safe PRO1160 is and if it works to treat the diseases under study The diseases under study will be Renal Cell Carcinoma RCCNasopharyngeal Carcinoma NPC and Non-Hodgkin Lymphoma NHL
This study will test the safety including side effects and determine the characteristics of a drug called PRO1160 in participants with solid tumors
Participants will have solid tumor or liquid cancer that has spread through the body metastatic or cannot be removed with surgery unresectable
This Phase 12 study will have two parts Part A of the study will find out how much and how frequently PRO1160 should be given to participants Part B will use the dose and schedule found in Part A to find out how safe PRO1160 is and if it works to treat the diseases under study The diseases under study will be Renal Cell Carcinoma RCCNasopharyngeal Carcinoma NPC and Non-Hodgkin Lymphoma NHL
Detailed Description:
This is a Phase 12 study of PRO1160 a CD70 targeted antibody-drug conjugate to evaluate the safety tolerability PK and antitumor activity of PRO1160 in patients with selected locally advanced or metastatic solid and liquid tumors including renal cell carcinoma nasopharyngeal carcinoma and non-hodgkin lymphoma This study consists of 2 parts Part A Dose Escalation and Part B Dose Expansion
Part A may evaluate up to 7 dose levels of PRO1160 on Day 1 of a 21 day cycle by IV infusion
Part B will be initiated at a dose level based on a comprehensive analysis of safety tolerability clinical PK PD and activity data from Part A in up to 4 different cohorts of up to 20 patients per cohort
Patients will continue to receive study treatment until the first instance of disease progression unacceptable toxicity investigator decision consent withdrawal study termination by the Sponsor pregnancy or death
Part A may evaluate up to 7 dose levels of PRO1160 on Day 1 of a 21 day cycle by IV infusion
Part B will be initiated at a dose level based on a comprehensive analysis of safety tolerability clinical PK PD and activity data from Part A in up to 4 different cohorts of up to 20 patients per cohort
Patients will continue to receive study treatment until the first instance of disease progression unacceptable toxicity investigator decision consent withdrawal study termination by the Sponsor pregnancy or death
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