The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Maplirpacept (TTI-622/PF-07901801) is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Australia, Israel, Japan, Taiwan
for more information at clinicaltrials.gov
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.
DRUG: maplirpacept (PF-07901801)
Intravenous infusionDRUG: Glofitamab
Intravenous infusionDRUG: Obinutuzumab
Intravenous infusionEXPERIMENTAL: 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).
DRUG: maplirpacept (PF-07901801)
Intravenous infusionDRUG: Glofitamab
Intravenous infusionDRUG: Obinutuzumab
Intravenous infusionEXPERIMENTAL: 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.
DRUG: maplirpacept (PF-07901801)
Intravenous infusionDRUG: Glofitamab
Intravenous infusionDRUG: Obinutuzumab
Intravenous infusionPhase 1b: Number of participants with Dose limiting toxicities (DLT)
DLTs are a predefined set of adverse events that are at least possibly related to any or all of the investigational agents.
21 days following first PF-07901801 dose
Phase 2: Objective Response (OR)
OR defined as proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Lugano Response Classification Criteria 2014.
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)
PK Bridging Sub-Study: Serum Concentration Versus Time Summary of PF-07901801 process 3
Pre and post-dose concentrations of PF-07901801 process 3
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)
Phase 1b, Phase 2 and PK Bridging Sub-Study: Frequency of adverse events (AE)
Type and severity (severity according to the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0). Severity of Cytokine Release Syndrome (CRS) and Immune effector cell-associated neurotoxicity syndrome (ICANS) assessed according to ASTCT criteria.
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)
Phase 1b, Phase 2 and PK Bridging Sub-Study: Frequency of clinical laboratory abnormalities
Type and severity (severity according to the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0).
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)
Phase 1b and PK Bridging Sub-Study: Objective Response (OR)
OR defined as proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Lugano Response Classification Criteria 2014.
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)
Phase 1b, Phase 2 and PK Bridging Sub-Study: Duration of Response (DoR)
DoR defined as the time from the first documentation of OR until progressive disease (PD), or death due to any cause, whichever occurs first.
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)
Phase 1b, Phase 2 and PK Bridging Sub-Study: Complete Response (CR)
CR defined per Lugano Response Classification Criteria 2014
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)
Phase 1b, Phase 2 and PK Bridging Sub-Study: Duration of Complete Response (DoCR)
DoCR defined as the time from the first documentation of a CR until PD, or death due to any cause, whichever occurs first.
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)
Phase 1b, Phase 2 and PK Bridging Sub-Study: Progression Free Survival (PFS)
PFS is defined as the time from the date of first dose until PD per Lugano Response Classification Criteria 2014, or death due to any cause, whichever occurs first.
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)
Phase 1b and Phase 2: Serum Concentration Versus Time Summary of PF-07901801
Pre- and post-dose concentrations of PF-07901801
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)
Phase 1b and Phase 2: Number of participants with Anti-Drug Antibody (ADA) against PF-07901801
To evaluate immunogenicity of PF-07901801
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)
Phase 1b and Phase 2: Number of participants with Neutralizing antibody (NAb) for PF-07901801
To evaluate immunogenicity of PF-07901801
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)
PK Bridging Sub-Study: Number of participants with Anti-Drug Antibody (ADA) against PF-07901801 process 3
To evaluate immunogenicity of PF-07901801
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)
PK Bridging Sub-Study: Number of participants with Neutralizing antibody (NAb) for PF-07901801
To evaluate immunogenicity of PF-07901801
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)
90
Sponsor: Pfizer
Collaborator: Hoffmann-La Roche
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT05896163
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