A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors
A Study of SGN-PDL1V in Advanced Solid Tumors
Kawai Norisuke
Pfizer R&D Japan G.K.
Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo
+81-3-5309-7000
clinical-trials@pfizer.com
Clinical Trials Information Desk
Pfizer R&D Japan G.K.
Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo
+81-3-5309-7000
clinical-trials@pfizer.com
Recruiting
April. 24, 2025
315
Interventional
non-randomized controlled trial
open(masking not used)
uncontrolled control
single assignment
treatment purpose
Inclusion Criteria:
*Parts A and B:
-Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types
#Non-small cell lung cancer (NSCLC)
#Head and neck squamous cell carcinoma (HNSCC) (except nasopharyngeal cancer)
#Esophageal squamous cell carcinoma (SCC)
#Triple negative breast cancer (TNBC)
-Participants must have disease that is relapsed or refractory, that has progressed on approved therapies, be intolerant to or refused such therapies, or such and therapies are contraindicated and in the judgement of the investigator, should have no appropriate SoC therapeutic option
-Participants must have PD-L1 expression based on historical testing
*Part C:
-Participants must have disease that is relapsed or refractory or be intolerant to SoC therapies and must have one of the following tumor types
#HNSCC
#Participants with HNSCC must have histologically or cytologically-confirmed HNSCC
#NSCLC
#Participants must have histologically or cytologically-confirmed NSCLC. Participants with SCC and non--SCC histology are eligible. Note: Participants with a neuroendocrine component or histology are not eligible.
#Esophageal SCC
#Ovarian cancer
#Melanoma
#TNBC
#Gastric cancer
-Participants must have been previously tested for PD-L1 expression and should have PD-L1 expression >=1 or <1 by CPS or TPS based on historical testing
*Part D and Part E:
-Participants must have histologically or cytologically-confirmed disease of the HNSCC or NSCLC
-Participants must have PD-L1 expression based on historical testing
-Participants with NSCLC; PD-L1 expression >= 1% by TPS
-Participants with HNSCC; PD--L1 expression >=1 by CPS
*Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
*Measurable disease per RECIST v1.1 at baseline
Exclusion Criteria:
*History of another malignancy within 3 years of first dose of study treatment or any evidence of residual disease from a previously diagnosed malignancy.
*Known active central nervous system metastases. Participants with previously-treated brain metastases may participate provided they:
-Are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment
-Have no new or enlarging brain metastases
-And are off of corticosteroids prescribed for symptoms associate with brain metastases for at least 7 days prior to first dose of study treatment
*Lepto-meningeal disease
*Prior treatment with an anti-PD-L1 agent within less than 5 half-lives. This duration of time will vary according to the half-life of the specific agent.
*Previous receipt of an monomethylauristatin E (MMAE)-containing agent.
*Pre-existing neuropathy >=Grade 2 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
There are additional inclusion criteria. The study center will determine if criteria for participations are met.
18age old over
No limit
Both
NSCLC
HNSCC
Esophageal SCC
4 more
*Drug: PF-08046054
-Given into the vein (IV; intravenously)
-Other Names:
#SGN-PDL1V
*Drug: pembrolizumab
-200 mg once every 3 weeks given into the vein (IV; intravenously)
-Other Names:
#Keytruda
*Number of participants with adverse events (AEs) [Time Frame: Through approximately 90 days after last study treatment; up to 3 years]
-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.
*Number of participants with laboratory abnormalities [Time Frame: Through approximately 90 days after last study treatment; up to 3 years]
*Number of participants with dose-limiting toxicities (DLTs) [Time Frame: Through the first cycle of study treatment; approximately 1 month]
*Number of participants with DLTs by dose level [Time Frame: Through the first cycle of study treatment; approximately 1 month]
*Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment [Time Frame: Up to approximately 3 years]
-The proportion of participants with a partial response (PR) or complete response (CR) which is subsequently confirmed per RECIST v1.1 as assessed by the investigator.
*Duration of objective response (DOR) per RECIST v1.1 by investigator assessment [Time Frame: Up to approximately 3 years]
-The time from the start of the first documentation of objective tumor response (CR or PR that is subsequently confirmed) to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or to death due to any cause.
*Progression-free survival (PFS) per RECIST v1.1 by investigator assessment [Time Frame: Up to approximately 3 years]
-The time from the start of study treatment to the first documentation of PD (per RECIST v1.1 as assessed by the investigator) or death due to any cause.
*Overall survival (OS) [Time Frame: Up to approximately 3 years]
-The time from the start of study treatment to death due to any cause.
*Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC) [Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years]
-To be summarized using descriptive statistics
*PK parameter - Maximum concentration (Cmax) [Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years]
-To be summarized using descriptive statistics
*PK parameter - Trough concentration (Ctrough) [Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years]
-To be summarized using descriptive statistics
*Incidence of anti-drug antibodies (ADAs) [Time Frame: Through 30-37 days after last study treatment; up to approximately 3 years]
-To be summarized using descriptive statistics
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.
NCT05208762
ClinicalTrials.gov
Belgium/Canada/France/Germany/Italy/Netherlands/Spain/United Kingdom/United States
