C5851001 - SGNPDL1V-001 - A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors

Studio Clinico

Patologia: Melanoma, Neoplasie della mammella, Neoplasie del polmone, Neoplasie dello stomaco, Tumori dell’esofago, Tumori dell’ovaio, Tumori della testa e del collo

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: 1,

Linee di trattamento: Non applicabile

Criteri di inclusione: 

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.

Criteri di esclusione: 

- 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.

Numero di pazienti previsti: 

20

Schema di trattamento: 

Experimental: PF-08046054 (SGN-PDL1V) Monotherapy given into the vein (IV; intravenously).
Experimental: PF-08046054 Combination Therapy: PF-08046054 (SGN-PDL1V) given into the vein (IV; intravenously) + pembrolizumab 200 mg once every 3 weeks given into the vein (IV; intravenously).

Trattamento sperimentale: 

PF-08046054 (PD-L1-directed Antibody Drug Conjugate) Monotherapy

Trattamento di controllo: 

PF-08046054 (PD-L1-directed Antibody Drug Conjugate) + pembrolizumab

Obiettivi primari dello studio: 

- Number of participants with adverse events (AEs)
- Number of participants with laboratory abnormalities
- Number of participants with dose-limiting toxicities (DLTs)
- Number of participants with DLTs by dose level.

Data di inizio dell'arruolamento: 21.01.2022

Data di fine dell'arruolamento: 31.12.2025

Centri partecipanti

Nord Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2023-506604-18-00

Data di inserimento: 16.04.2025

Data di aggiornamento: 08.07.2025

Promotore

Seagen Inc.

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd