Informations générales (source: ClinicalTrials.gov)
A Phase 1 Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
Interventional
Phase 1
Seagen Inc. (Voir sur ClinicalTrials)
octobre 2022
décembre 2027
16 octobre 2024
This study will test the safety of a drug called PF-08046054/SGN-PDL1V alone and with
pembrolizumab in participants with solid tumors. It will also study the side effects of
this drug. A side effect is anything a drug does to your body besides treating your
disease.
Participants will have solid tumor cancer that has spread through the body (metastatic)
or cannot be removed with surgery (unresectable).
This study will have five parts. Parts A and B of the study will find out how much
PF-08046054/SGN- PDL1V should be given to participants. Part C will use the dose found in
Parts A and B to find out how safe PF-08046054/SGN-PDL1V is and if it works to treat
solid tumor cancers. In Part D and E, participants will be given PF-08046054/SGN-PDL1V
with pembrolizumab to find out how safe this combination is and if it works to treat
solid tumor cancers.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/09/2024 13:49:41 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | St�phane CHAMPIAT | 24/06/2024 21:05:27 | Contacter | ||
Critères
Tous
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
- 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
- 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.