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.
Clinical Trial Details
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Other or Multiple Cancer Types
PD-L1-directed Antibody Drug Conjugate
PF-08046054, SGN-PDL1V is an investigational compound. Its safety and efficacy have not been established
A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors
Phase 1
NCT05208762
Active enrolling
Locations
United States, Belgium, Canada, France, Germany, Italy, Netherlands, Spain, United Kingdom
Study design
Participant Group/Arm
EXPERIMENTAL: SGN-PDL1V Monotherapy
SGN-PDL1V monotherapy
Intervention/Treatment
DRUG: SGN-PDL1V
Given into the vein (IV; intravenously)
Participant Group/Arm
EXPERIMENTAL: SGN-PDL1V Combination Therapy
SGN-PDL1V + pembrolizumab
Intervention/Treatment
DRUG: SGN-PDL1V
Given into the vein (IV; intravenously)
DRUG: pembrolizumab
200 mg once every 3 weeks given into the vein (IV; intravenously)
Key eligibility criteria
Inclusion criteria
- Parts A and B:
- Participants must have one of the following histologically- or cytologically-confirmed metastatic or unresectable solid tumor types
- Parts A and B:
- 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 testi
- 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
- Part C:
- 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 testi
- Part D:
- Participants must have histologically or cytologically-confirmed disease of the HNSCC
- Participants must have PD-L1 expression based on historical testi
- 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 treatme
- 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.
Key dates
Study start date
- October 2022
Estimated primary completion date
- December 2026
Key endpoints
Primary Outcome Measures
Outcome Measure
Number of participants with adverse events (AEs)
Measure Description
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.
Time Frame
Through approximately 90 days after last study treatment; up to 3 years
Outcome Measure
Number of participants with laboratory abnormalities
Time Frame
Through approximately 90 days after last study treatment; up to 3 years
Outcome Measure
Number of participants with dose-limiting toxicities (DLTs)
Time Frame
Through the first cycle of study treatment; approximately 1 month
Outcome Measure
Number of participants with DLTs by dose level
Time Frame
Through the first cycle of study treatment; approximately 1 month
Secondary Outcome Measures:
Outcome Measure
Confirmed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) by investigator assessment
Measure Description
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.
Time Frame
Up to approximately 3 years
Outcome Measure
Duration of objective response (DOR) per RECIST v1.1 by investigator assessment
Measure Description
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.
Time Frame
Up to approximately 3 years
Outcome Measure
Progression-free survival (PFS) per RECIST v1.1 by investigator assessment
Measure Description
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.
Time Frame
Up to approximately 3 years
Outcome Measure
Overall survival (OS)
Measure Description
The time from the start of study treatment to death due to any cause.
Time Frame
Up to approximately 3 years
Outcome Measure
Pharmacokinetic (PK) parameter - Area under the concentration-time curve (AUC)
Measure Description
To be summarized using descriptive statistics
Time Frame
Through 30-37 days after last study treatment; up to approximately 3 years
Outcome Measure
PK parameter - Maximum concentration (Cmax)
Measure Description
To be summarized using descriptive statistics
Time Frame
Through 30-37 days after last study treatment; up to approximately 3 years
Outcome Measure
PK parameter - Trough concentration (Ctrough)
Measure Description
To be summarized using descriptive statistics
Time Frame
Through 30-37 days after last study treatment; up to approximately 3 years
Outcome Measure
Incidence of anti-drug antibodies (ADAs)
Measure Description
To be summarized using descriptive statistics
Time Frame
Through 30-37 days after last study treatment; up to approximately 3 years
Number of participants
322
Collaborators and investigators
Sponsor: Seagen Inc.
Collaborator: None