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 Not-enrolling
United States, Japan, Korea, Republic of, Puerto Rico
for more information at clinicaltrials.gov
EXPERIMENTAL: Phase 1b
Participants will be allocated to sequential dose levels of maplirpacept (PF-07901801), administered in combination with standard doses of tafasitamab and lenalidomide, to select two doses for further evaluation in Phase 2. Approximately 20 participants will be enrolled.
DRUG: Maplirpacept
Intravenous infusionDRUG: Tafasitamab
Intravenous infusionDRUG: Lenalidomide
Oral (by mouth)EXPERIMENTAL: Phase 2
Participants will be randomized to 1 of 2 different dose levels of maplirpacept (PF-07901801) which will be administered in combination with standard doses of tafasitamab and lenalidomide. Approximately 50 participants will be enrolled (25 per dose).
DRUG: Maplirpacept
Intravenous infusionDRUG: Tafasitamab
Intravenous infusionDRUG: Lenalidomide
Oral (by mouth)Key Exclusion Criteria:
Phase 1b: Dose limiting toxicity (DLT) rate
DLTs are a predefined set of adverse events that are at least possibly related to any or all of the investigational agents.
28 days following first dose
Phase 2: Objective Response Rate (ORR)
OR defined as complete response or partial response as 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 and Phase 2: 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).
Time from the date of first dose of study intervention through 28 days after last dose of study intervention (assessed up to approximately 24 months)
Phase 1b and Phase 2: 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 study intervention (assessed up to approximately 24 months)
Phase 1b: Objective Response Rate (ORR)
OR defined as complete response or partial response 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 and Phase 2: Duration of Response (DoR)
CR and PR defined per Lugano Response Classification Criteria 2014
Time from the first documentation of objective response until disease progression or death due to any cause, whichever occurs first (assessed up to approximately 24 months)
Phase 1b and Phase 2: Complete Response Rate (CRR)
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 and Phase 2: Duration of Complete Response (DoCR)
CR defined per Lugano Response Classification Criteria 2014
Time from the first documentation of a CR until PD, or death due to any cause, whichever occurs first (assessed up to approximately 24 months)
Phase 1b and Phase 2: Progression Free Survival (PFS)
Progression defined per Lugano Response Classification Criteria 2014
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: Pharmacokinetic parameters of PF-07901801
Pre- and post-dose concentrations of PF-07901801
On the first and 8th day of the first 28-day cycle, then the first day of every cycle through 6 cycles, then every third cycle through 13 cycles and every sixth cycle thereafter until end of treatment (assessed up to approximately 24 months)
Phase 1b and Phase 2: Pharmacokinetic parameters of tafasitamab
Pre-dose concentrations of tafasitamab
On the first day of every 28-day cycle through 6 cycles, then every third cycle through 13 cycles and every sixth cycle thereafter until end of treatment (assessed up to approximately 24 months)
Phase 1b and Phase 2: Pharmacokinetic parameters of of lenalidomide
Pre-dose concentrations of lenalidomide.
On the first first day of the first four 28-day cycles.
Phase 1b and Phase 2: Incidence of Anti-Drug Antibody (ADA) against PF-07901801
To evaluate immunogenicity of PF-07901801
On the first day of every 28-day cycle through 6 cycles, then every third cycle through 13 cycles and every sixth cycle thereafter until end of treatment (assessed up to approximately 24 months)
Phase 1b and Phase 2: Incidence of Anti-Drug Antibody (ADA) against tafasitamab
To evaluate immunogenicity of tafasitamab
On the first day of every 28-day cycle through 6 cycles, then every third cycle through 13 cycles and every sixth cycle thereafter until end of treatment (assessed up to approximately 24 months)
Phase 1b and Phase 2: Neutralizing antibody (NAb) titers for PF-07901801
To evaluate immunogenicity of PF-07901801
On the first day of every 28-day cycle through 6 cycles, then every third cycle through 13 cycles and every sixth cycle thereafter until end of treatment (assessed up to approximately 24 months)
Phase 1b and Phase 2: Neutralizing antibody (NAb) titers for tafasitamab
To evaluate immunogenicity of tafasitamab
On the first day of every 28-day cycle through 6 cycles, then every third cycle through 13 cycles and every sixth cycle thereafter until end of treatment (assessed up to approximately 24 months)
4
Sponsor: Pfizer
Collaborator: MorphoSys AG, Incyte Corporation
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.
NCT05626322
Back
