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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05896163




Registration number
NCT05896163
Ethics application status
Date submitted
10/05/2023
Date registered
9/06/2023

Titles & IDs
Public title
A Study to Learn About the Effects of Two Study Medicines (Maplirpacept [PF-07901801] And Glofitamab) When Given Together In People With Relapsed Or Refractory Diffuse Large B Cell Lymphoma.
Scientific title
A PHASE 1b/2, OPEN-LABEL STUDY OF PF-07901801 IN COMBINATION WITH GLOFITAMAB AFTER A FIXED, SINGLE DOSE OF OBINUTUZUMAB IN PARTICIPANTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA NOT ELIGIBLE FOR STEM CELL TRANSPLANTATION
Secondary ID [1] 0 0
2022-502822-41-00
Secondary ID [2] 0 0
C4971006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell 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 - maplirpacept (PF-07901801)
Treatment: Drugs - Glofitamab
Treatment: Drugs - Obinutuzumab

Experimental: Phase 1b - Participants will be allocated to sequential dose levels of PF-07901801, administered in combination with fixed doses of glofitamab after a dose of obinutuzumab, to select two doses of PF-07901801 for further evaluation in Phase 2. Approximately 20 participants will be enrolled.

Experimental: Phase 2 - Participants will be randomized to 1 of 2 different dose levels of PF-07901801 which will be administered in combination with fixed doses of glofitamab after a dose of obinutuzumab. Approximately 50 participants will be enrolled (25 per dose).

Experimental: PK Bridging Sub-Study - Participants will be allocated to 2 dose levels of PF-07901801 manufactured with process 3, administered in combination with fixed doses of glofitamab after a dose of obinutuzumab, to evaluate the pharmacokinetic of PF-07901801 using Process 3 material and determine a dose comparable to the recommended PF-07901801 dose for phase 3 determined in Phase 2. Approximately 20 participants will be enrolled.


Treatment: Drugs: maplirpacept (PF-07901801)
Intravenous infusion

Treatment: Drugs: Glofitamab
Intravenous infusion

Treatment: Drugs: Obinutuzumab
Intravenous infusion

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1b: Number of participants with Dose limiting toxicities (DLT)
Timepoint [1] 0 0
21 days following first PF-07901801 dose
Primary outcome [2] 0 0
Phase 2: Objective Response (OR)
Timepoint [2] 0 0
Time from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 24 months)
Primary outcome [3] 0 0
PK Bridging Sub-Study: Serum Concentration Versus Time Summary of PF-07901801 process 3
Timepoint [3] 0 0
Cycle 1: Pre-infusion (Pre) on Day 1 and 8, post-infusion (Post) on Day 1, 2 and 4. Cycle 2: Pre on Day 15, Post on Day 15, 16 and 18, Cycles 3, 4, 5, 7, 10, 13 and every 6 cycle thereafter until end of treatment (approximately 24 months)
Secondary outcome [1] 0 0
Phase 1b, Phase 2 and PK Bridging Sub-Study: Frequency of adverse events (AE)
Timepoint [1] 0 0
Time from the date of first dose of study intervention through 28 days after last dose of PF-07901801 or 90 days after last dose of glofitamab or obinutuzumab (assessed up to approximately 24 months)
Secondary outcome [2] 0 0
Phase 1b, Phase 2 and PK Bridging Sub-Study: Frequency of clinical laboratory abnormalities
Timepoint [2] 0 0
Time from the date of first dose of study intervention through 28 days after last dose of PF-07901801 or 90 days after last dose of glofitamab or obinutuzumab (assessed up to approximately 24 months)
Secondary outcome [3] 0 0
Phase 1b and PK Bridging Sub-Study: Objective Response (OR)
Timepoint [3] 0 0
Time from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 24 months)
Secondary outcome [4] 0 0
Phase 1b, Phase 2 and PK Bridging Sub-Study: Duration of Response (DoR)
Timepoint [4] 0 0
Time from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 24 months)
Secondary outcome [5] 0 0
Phase 1b, Phase 2 and PK Bridging Sub-Study: Complete Response (CR)
Timepoint [5] 0 0
Time from the date of first dose of study intervention until the first documentation of disease progression, death, or start of new anticancer therapy (assessed up to approximately 24 months)
Secondary outcome [6] 0 0
Phase 1b, Phase 2 and PK Bridging Sub-Study: Duration of Complete Response (DoCR)
Timepoint [6] 0 0
Time from the date of first dose of study intervention until PD, or death due to any cause, whichever occurs first (assessed up to approximately 24 months)
Secondary outcome [7] 0 0
Phase 1b, Phase 2 and PK Bridging Sub-Study: Progression Free Survival (PFS)
Timepoint [7] 0 0
Time from the date of first dose of study intervention until PD, or death due to any cause, whichever occurs first (assessed up to approximately 24 months)
Secondary outcome [8] 0 0
Phase 1b and Phase 2: Serum Concentration Versus Time Summary of PF-07901801
Timepoint [8] 0 0
Pre and post-infusion on Day 1 of Cycle 1 and 2 (each cycle is 21 days), Pre-infusion on Day 8 of Cycle 1, Pre-infusion on Day 1 of Cycles 3, 4, 5, 7, 10, 13 and every 6 cycle thereafter until end of treatment (approximately 24 months)
Secondary outcome [9] 0 0
Phase 1b and Phase 2: Number of participants with Anti-Drug Antibody (ADA) against PF-07901801
Timepoint [9] 0 0
On the first day of every 21-day cycle through 5 cycles, then every third cycle from cycle 7 through cycle 13 and then every sixth cycle thereafter until end of PF-07901801 treatment (assessed up to approximately 24 months)
Secondary outcome [10] 0 0
Phase 1b and Phase 2: Number of participants with Neutralizing antibody (NAb) for PF-07901801
Timepoint [10] 0 0
On the first day of every 21-day cycle through 5 cycles, then every third cycle from cycle 7 through cycle 13 and then every sixth cycle thereafter until end of PF-07901801 treatment (assessed up to approximately 24 months)
Secondary outcome [11] 0 0
PK Bridging Sub-Study: Number of participants with Anti-Drug Antibody (ADA) against PF-07901801 process 3
Timepoint [11] 0 0
On the first day of every 21-day cycle through 5 cycles, then every third cycle from cycle 7 through cycle 13 and then every sixth cycle thereafter until end of PF-07901801 treatment (assessed up to approximately 24 months)
Secondary outcome [12] 0 0
PK Bridging Sub-Study: Number of participants with Neutralizing antibody (NAb) for PF-07901801
Timepoint [12] 0 0
On the first day of every 21-day cycle through 5 cycles, then every third cycle from cycle 7 through cycle 13 and then every sixth cycle thereafter until end of PF-07901801 treatment (assessed up to approximately 24 months)

Eligibility
Key inclusion criteria
Key

* Histologically confirmed diagnosis of DLBCL
* Relapsed or refractory disease
* Participant is not be a candidate for or is unwilling to undergo high dose chemotherapy and subsequent stem cell transplant and/or is unable to receive chimeric antigen receptor (CAR) T-cell therapy
* Previous treatment with at least two prior lines of systemic therapy (for phase 2, at least 2 and no more than 4 prior lines of systemic therapy). Prior therapy must include an anti-CD20 antibody.
* Adequate bone marrow, hepatic and renal function
* Eastern Cooperative Oncology Group (ECOG) =2

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with anti-CD47 and/or prior glofitamab or anti-CD20 x CD3 containing regimen. Refractoriness to an obinutuzumab monotherapy containing regimen.
* Prior allogeneic stem cell transplantation or autologous stem cell transplantation within 12 weeks prior to enrolment
* High Grade B-Cell Lymphoma
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection.

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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Minnesota
Country [3] 0 0
United States of America
State/province [3] 0 0
Missouri
Country [4] 0 0
United States of America
State/province [4] 0 0
Washington
Country [5] 0 0
Israel
State/province [5] 0 0
Hamerkaz
Country [6] 0 0
Israel
State/province [6] 0 0
Hatsafon
Country [7] 0 0
Israel
State/province [7] 0 0
Yerushalayim
Country [8] 0 0
Japan
State/province [8] 0 0
Aichi
Country [9] 0 0
Japan
State/province [9] 0 0
Shizuoka
Country [10] 0 0
Japan
State/province [10] 0 0
Fukuoka
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taichung
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hoffmann-La Roche
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
ClinicalTrials.gov_Inquiries@pfizer.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests


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.