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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06088654




Registration number
NCT06088654
Ethics application status
Date submitted
12/10/2023
Date registered
18/10/2023

Titles & IDs
Public title
Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma
Scientific title
A Phase 1/2, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of IPH6501 in Patients With Relapsed and/or Refractory CD20-expressing Non-Hodgkin Lymphoma
Secondary ID [1] 0 0
IPH6501-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Hodgkin Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - IPH6501

Experimental: IPH6501 monotherapy -


Treatment: Drugs: IPH6501
phase 1 (dose finding) and phase 2 (dose expansion)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability
Timepoint [1] 0 0
From time of informed consent through treatment period and including the follow-up: up to 22 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
From time of informed consent through treatment period and including the follow-up: up to 22 months
Secondary outcome [2] 0 0
Duration Of Response (DoR)
Timepoint [2] 0 0
From time of informed consent through treatment period and including the follow-up: up to 22 months
Secondary outcome [3] 0 0
Progression Free Survival (PFS)
Timepoint [3] 0 0
From time of informed consent through treatment period and including the follow-up: up to 22 months
Secondary outcome [4] 0 0
Maximum Observed Plasma Concentration (Cmax)
Timepoint [4] 0 0
From time of informed consent through treatment period and including the follow-up: up to 22 months
Secondary outcome [5] 0 0
Area Under the Plasma Concentration (AUC)
Timepoint [5] 0 0
From time of informed consent through treatment period and including the follow-up: up to 22 months
Secondary outcome [6] 0 0
Incidence of antidrug antibodies (ADA) against IPH6501
Timepoint [6] 0 0
From time of informed consent through treatment period and including the follow-up: up to 22 months

Eligibility
Key inclusion criteria
Main Inclusion criteria

* Patients with advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin's lymphoma (NHL) including the following types defined by WHO 2016: Diffuse Large B Cell Lymphoma (DLBCL); high grade; thymic; Follicular Lymphoma (FL); Mantle cell lymphoma (MCL); Marginal zone lymphoma (MZL)
* Relapsed, progressive and/or refractory disease without established alternative therapy
* Must have received at least 2 prior systemic therapies including at a minimum anti-CD20 antibody therapy (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
* Eastern Cooperative Oncology Group (ECOG) performance status of = 2
* Adequate organ and hematological function
* Able to provide a fresh biopsy from a safely accessible site (or historical biopsy), per investigator determination.

Main
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Patients with another invasive malignancy in the last 2 years
* Prior chemotherapy, immunotherapy or other anti-cancer therapy within less than 4 weeks before study drug administration.
* Autologous stem cell transplant or treatment with CAR-T (Chimeric Antigen Receptor T-Cell) cell therapy within 100 days prior to first dose of study drug
* Subjects with brain or subdural metastases are not eligible, nor those with history of central nervous system (CNS) lymphoma
* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
* Known history of infection with human immunodeficiency virus (HIV) or hepatitis B or C
* Major surgery within 4 weeks before the first dose of study drug
* Comorbidities including diabetes, cardiovascular diseases, immunodeficiencies/autoimmune condition
* Pregnant / breastfeeding woman

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2028
Actual
Sample size
Target
184
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Wollongong Private Hospital - Wollongong
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Peninsula Private Hospital - Frankston
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3910 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
France
State/province [4] 0 0
Lille
Country [5] 0 0
France
State/province [5] 0 0
Lyon
Country [6] 0 0
France
State/province [6] 0 0
Nantes

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Innate Pharma
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Innate pharma
Address 0 0
Country 0 0
Phone 0 0
+33430303030
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06088654