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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04082936




Registration number
NCT04082936
Ethics application status
Date submitted
4/09/2019
Date registered
10/09/2019
Date last updated
15/11/2023

Titles & IDs
Public title
A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
Scientific title
A Phase 1/2 Open-label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Imvotamab (IGM-2323) as a Single Agent and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphomas
Secondary ID [1] 0 0
IGM-2323-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin Lymphoma 0 0
Follicular Lymphoma 0 0
DLBCL 0 0
Mantle Cell Lymphoma 0 0
Marginal Zone 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 - imvotamab

Experimental: Phase 1a (Dose Escalation) - Subjects will receive imvotamab via intravenous (IV) infusion weekly. No longer enrolling.

Experimental: Phase 1a (Q3W) - Subjects will receive imvotamab via intravenous (IV) infusion every 3 weeks. No longer enrolling.

Experimental: Phase 1a (Prior bi-specific) - Subjects treated with prior bi-specifics will receive imvotamab via IV infusion weekly. No longer enrolling.

Experimental: Phase 2 (DLBCL) - DLBCL subjects will receive imvotamab via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data. No longer enrolling.

Experimental: Phase 2 (FL) - FL subjects will receive imvotamab via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data. No longer enrolling.

Experimental: Phase 1b (Combination) - Subjects will receive imvotamab via IV infusion weekly and loncastuximab tesirine via IV infusion every 3 weeks.


Treatment: Drugs: imvotamab
Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Frequency of Adverse Events
Timepoint [1] 0 0
Baseline through approximately 30 days after last study treatment
Primary outcome [2] 0 0
Overall Response Rate (ORR)
Timepoint [2] 0 0
Baseline up to 5 years
Secondary outcome [1] 0 0
Objective Response Rate (ORR)
Timepoint [1] 0 0
Baseline up to 5 years
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Baseline up to 5 years

Eligibility
Key inclusion criteria
Key

- > 18 years of age: ECOG PS 0 or 1

- Relapsed or Refractory Follicular Lymphoma (FL), and Diffuse Large B-cell Lymphoma
(DLBCL), Mantle cell Lymphoma (MCL), Marginal Zone Lymphoma (MZL) in dose escalation

- Relapsed or refractory to at least two prior systemic treatment regimens (must include
anti-CD20 chemo-immunotherapy regimen). FL/MZL may be enrolled with a least 2 prior
systemic regimens which must include an anti-CD20, without the need for a prior
chemotherapy regimen)

- At least one bi-dimensionally measurable lesion (>1.5cm in it's longest dimension by
computerized tomography (CT scan)

- Good organ function

- Not eligible for autologous stem cell transplant (DLBCL subjects), due to
chemoresistant disease, medically unfit (organ function), or unwilling.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior allogeneic transplant

- ASCT within 100 days prior to the first imvotamab administration.

- Lack of response to prior treatment with CAR-T therapy, subjects with less than 3
months from prior CAR-T therapy to first dose of imvotamab, and prior CAR-T therapy
only allowed with Medical Monitor approval.

- Concurrent serious co-morbidities that could limit patients full participation and
compliance.

- Prior CD-targeting bispecific antibodies.

- Prior loncastuximab tesirine.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Other
Other design features
Phase
Phase 1/Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
Accrual to date
Final
97
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Monash Health - Clayton
Recruitment hospital [2] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Linear Clinical Resaerch - Nedlands
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha 10
Country [10] 0 0
France
State/province [10] 0 0
Poitiers
Country [11] 0 0
France
State/province [11] 0 0
Villejuif
Country [12] 0 0
Italy
State/province [12] 0 0
BG
Country [13] 0 0
Italy
State/province [13] 0 0
RM
Country [14] 0 0
Italy
State/province [14] 0 0
Bologna
Country [15] 0 0
Korea, Republic of
State/province [15] 0 0
Seoul
Country [16] 0 0
Spain
State/province [16] 0 0
Barcelona
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
IGM Biosciences, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
ADC Therapeutics S.A.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 1/2 study of imvotamab in adult subjects with relapsed or refractory B-cell
Non-Hodgkin Lymphoma. This study will consist of a dose-escalation stage, a combination
stage, and a randomized dose-expansion stage where subjects will be enrolled into
indication-specific expansion cohorts. imvotamab will be administered intravenously (IV).

Additional CD20-positive NHL histologies (e.g. MZL and MCL), may be allowed with Medical
Monitor approval during the Dose-Escalation Phase of the study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04082936
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ibrahim Qazi
Address 0 0
IGM Biosciences, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04082936