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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.
PF-08046040, SGN-CD70 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Netherlands
EXPERIMENTAL: Part A
SEA-CD70 dose escalation cohort in relapsed/refractory (HMA-failure) MDS
DRUG: SEA-CD70
Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycleEXPERIMENTAL: Part B
SEA-CD70 expansion cohort in relapsed/refractory (HMA-failure) MDS
DRUG: SEA-CD70
Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycleEXPERIMENTAL: Part C
SEA-CD70 expansion cohort in relapsed/refractory AML
DRUG: SEA-CD70
Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycleEXPERIMENTAL: Part D
SEA-CD70 + azacitidine dose-finding/dose optimization cohorts in relapsed/refractory MDS or MDS/AML, and previously untreated higher-risk MDS or MDS/AML
DRUG: SEA-CD70
Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycleDRUG: azacitidine
75mg/m\^2 injected under the skin (SC; subcutaneous) or given into the vein (IV; intravenously) on Days 1 through 7 of each treatment cycle.EXPERIMENTAL: Part E
SEA-CD70 + azacitidine expansion cohort in previously untreated higher-risk MDS or MDS/AML
DRUG: SEA-CD70
Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycleDRUG: azacitidine
75mg/m\^2 injected under the skin (SC; subcutaneous) or given into the vein (IV; intravenously) on Days 1 through 7 of each treatment cycle.EXPERIMENTAL: Part F
SEA-CD70 + azacitidine expansion cohort in relapsed/refractory MDS or MDS/AML
DRUG: SEA-CD70
Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycleDRUG: azacitidine
75mg/m\^2 injected under the skin (SC; subcutaneous) or given into the vein (IV; intravenously) on Days 1 through 7 of each treatment cycle.Exclusion Criteria (All Parts)
Number of participants with adverse events (AEs)
Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Number of participants with laboratory abnormalities
To be summarized using descriptive statistics.
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Number of participants with a dose-limiting toxicity (DLT) at each dose level (Parts A and D only)
To be summarized using descriptive statistics.
Though end of DLT evaluation period; up to approximately 4 weeks
AUC - Area under the plasma concentration-time curve
To be summarized using descriptive statistics.
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Tmax - Time to maximum concentration attained
To be summarized using descriptive statistics.
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Cmax - Maximum observed plasma concentration
To be summarized using descriptive statistics.
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Ctrough - Minimum plasma concentration per dosing interval
To be summarized using descriptive statistics.
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
T1/2 - Terminal elimination half-life
To be summarized using descriptive statistics.
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Incidence of antidrug antibodies (ADA)
To be summarized using descriptive statistics.
Through 30-37 days following last dose of SEA-CD70; up to approximately 2 years
Complete remission (CR) Rate and complete remission equivalent (CReq) rate
Proportion of participants with AML, MDS/AML or MDS who achieve CR or CReq
Up to approximately 4 years
Complete remission with incomplete blood count recovery (CRi) rate
Proportion of participants with AML who achieve CRi
Up to approximately 4 years
Complete remission with limited count recovery (CRL) rate for participants with MDS or MDS/AML
Proportion of participants with MDS or MDS/AML who achieve CRL
Up to approximately 4 years
Complete remission with partial hematologic recovery (CRh) rate
Proportion of participants with AML, MDS/AML, or MDS who achieve CRh
Up to approximately 4 years
Hematologic response (HI) rate
Proportion of participants with MDS or MDS/AML with HI
Up to approximately 4 years
Overall response rate (ORR)
For AML, the proportion of participants who achieve a best response of CR, CRi, CRh, or partial response (PR). For MDS, the proportion of participants who achieve a best response of CR, CReq, CRL, CRh, PR, or HI
Up to approximately 4 years
Duration of remission (DOR)
For AML, the time from first CR/CRi/CRh/PR response to the first documentation of disease progression, start of new anticancer therapy, or death due to any cause. For MDS, the time from first CR (or Req)/CRL/CRh/PR to the first documentation of disease progression, start of new anticancer therapy, or death due to any cause
Up to approximately 4 years
Overall survival (OS)
Time from start of study treatment to the date of death due to any cause
Up to approximately 4 years
Event-free survival (EFS)
Time from first dose to the first documentation of progression, failure to achieve remission within 6 months of study entry, disease relapse, or death due to any cause, whichever comes first.
Up to approximately 4 years
Progression-free survival (PFS)
Time from first dose to the first documentation of progression, disease relapse, or death from any cause, whichever comes first
Up to approximately 4 years
MRD-negative ORR
Proportion of participants with AML or MDS who achieve MRD-negative ORR
Up to approximately 4 years
Time to response (TTR)
Time from start of study treatment to the first documentation of objective response
Up to approximately 4 years
Rate of conversion to transfusion independence (TI)
Proportion of participants who convert from transfusion dependence at baseline to TI post-baseline
Up to approximately 4 years
Rate of TI maintenance
Proportion of participants who were TI at baseline and maintain TI post-baseline
Up to approximately 4 years
140
Sponsor: Seagen Inc.
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: