Informations générales (source: ClinicalTrials.gov)
An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors
Interventional
Phase 1
Seagen, a wholly owned subsidiary of Pfizer (Voir sur ClinicalTrials)
novembre 2023
septembre 2030
23 juillet 2026
This clinical trial is studying advanced solid tumors. Solid tumors are cancers that
start in a part of your body like your lungs or liver instead of your blood. Once tumors
have grown bigger in one place but haven't spread, they're called locally advanced. If
your cancer has spread to other parts of your body, it's called metastatic. When a cancer
has gotten so big it can't easily be removed or has spread to other parts of the body, it
is called unresectable. These types of cancer are harder to treat.
Participants in this study must have cancer that has come back or did not get better with
treatment. Participants must have a solid tumor cancer that can't be treated with
standard of care drugs.
This clinical trial uses an experimental drug called PF-08046050. PF-08046050 is a type
of antibody-drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill
them. They may also stick to some normal cells.
This study will test the safety of PF-08046050 in participants with solid tumors that are
hard to treat or have spread throughout the body.
This study has 5 different study parts. Part A and Part B of the study will find out how
much PF-08046050 should be given to participants. Part C will use the information from
Parts A and B to see if PF-08046050 is safe and if it works to treat certain solid tumor
cancers. Part D and E of the study, together with information from Parts A and B, will
find out how much PF-08046050 should be given in combination with other anti-cancer
agents. Part E will use the information from Parts A, B, and D to see if PF-08046050 is
safe in combination with other anti-cancer agents and if it works to treat a certain
solid tumor.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Yohann LORIOT | 08/06/2026 11:30:06 | Contacter | ||
Critères
Tous
1. Tumor type:
- Participants in Part A (dose escalation) and Part B (dose optimization) must
have histologically- or cytologically-confirmed metastatic or unresectable
solid tumor malignancy. Must have relapsed, refractory, or progressive disease,
and should have no appropriate standard therapy available.
- Participants in Part A must have one of the following tumor types:
colorectal cancer (CRC); gastric carcinoma (GC) or gastroesophageal
junction adenocarcinoma (GEJ); non-small cell lung cancer (NSCLC); or
pancreatic ductal adenocarcinoma (PDAC).
- The tumor types to be enrolled in Part B will be identified by the sponsor
from among those specified in Part A.
- Participants in Part C (dose expansion) must have one of the following
histologically- or cytologically-confirmed metastatic or unresectable solid
tumor malignancies.
- CRC (adenocarcinoma of the colon or rectum) and must have received no more
than 2 prior chemotherapy regimens for the treatment of advanced
colorectal cancer and evidence of either progressive disease or
intolerance to their last regimen.
- PDAC with one or more metastatic lesions measurable by computed
tomography/magnetic resonance imaging according to RECIST v1.1 criteria;
and must have received no more than 1 prior chemotherapy regimen for the
treatment of advanced PDAC and evidence of either progressive disease or
intolerance to that regimen.
- GC or GEJ and must have received prior platinum and fluoropyrimidine-based
chemotherapy.
- NSCLC and must have received platinum-based therapy. If eligible and
consistent with local standard of care must have received a PD-1/PD-L1
inhibitor. In addition, participants with tumor genomic
mutations/alterations for which approved targeted therapies are available
per local standard of care, must have received such therapies.
- Small cell lung cancer (SCLC) and must have received platinum-based
therapy for extensive-stage disease and no more than 3 prior lines of
therapy. If eligible and consistent with local standard of care must have
received a PD 1/PD-L1 inhibitor.
- CRC participants in Part D and Part E (bevacizumab combination therapy) must
have histologically confirmed unresectable or metastatic adenocarcinoma of the
colon or rectum. Received a maximum of 2 prior chemotherapy regimens for the
treatment of advanced colorectal cancer and had demonstrated progressive
disease or intolerance to their last regimen.
- CRC participants in Part D and Part E (5FU/LV + bevacizumab and 5FU/LV +
oxaliplatin + bevacizumab combination therapy) must have histologically
confirmed unresectable or metastatic adenocarcinoma of the colon or rectum.
Must not have received a prior TOPO1 inhibitor (such as irinotecan or
nanoliposomal irinotecan) in any setting. 1L cohorts: No prior chemotherapy for
advanced disease. 2L cohorts (applicable to 5FU/LV + bevacizumab combination
only): 1 prior chemotherapy regimen for the treatment of advanced disease,
which must have included a fluoropyrimidine and oxaliplatin.
> 2L PDAC participants in Part E (5FU/LV combination therapy) must have
histologically or cytologically confirmed metastatic pancreatic ductal
adenocarcinoma. One or more metastatic lesions measurable by computed
tomography/magnetic resonance imaging according to Response Evaluation Criteria in
Solid Tumors (RECIST) version 1.1 criteria.
> 1L PDAC participants in Part E (5FU/LV + oxaliplatin combination therapy) must
have histologically or cytologically confirmed metastatic pancreatic ductal
adenocarcinoma that has not been previously treated in the metastatic setting. One
or more metastatic lesions measurable by computed tomography/magnetic resonance
imaging according to Response Evaluation Criteria in Solid Tumors (RECIST) version
1.1 criteria. No prior chemotherapy for PDAC with the following exception: Patients
who received adjuvant/neoadjuvant chemotherapy and who had recurrence more than 12
months after completion of adjuvant/neoadjuvant chemotherapy are eligible.
2. Participants enrolled in the following study parts should have a tumor site that is
accessible for biopsy(ies) and agree to biopsy(ies) and/or submission of archival
tissue:
- Monotherapy dose optimization (Part B)
- Monotherapy (Part C) and combination therapy (Part E) disease-specific
expansion cohorts
3. An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
4. Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at
baseline.
Exclusion Criteria:
1. Previous exposure to CEACAM5-targeted therapy.
2. Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu
(trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).
3. History of another malignancy within 3 years before the first dose of study
intervention, or any evidence of residual disease from a previously diagnosed
malignancy.
4. Active cerebral/meningeal disease related to the underlying malignancy. Participants
with a history of cerebral/meningeal disease related to the underlying malignancy
are allowed if prior central nervous system disease has been treated and the
participant is clinically stable (defined as not having received steroid treatment
for symptoms related to cerebral/meningeal disease for at least 2 weeks prior to
enrollment and with no ongoing related AEs).
> Criteria related to bevacizumab administration (participants in Parts D and E)
5. History of allergic reactions or hypersensitivity to bevacizumab or any of its
excipients.
6. History of hypersensitivity to Chinese Hamster Ovary cell products or other
recombinant human or humanized antibodies.
7. Serious non-healing wound, non-healing ulcer, or non-healing bone fracture.
8. Deep venous thromboembolic event within 4 weeks prior to enrollment
9. Known coagulopathy that increases risk of bleeding, bleeding diatheses.
10. History of any life-threatening VEGF-related adverse event