A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors

Launched by SEAGEN, A WHOLLY OWNED SUBSIDIARY OF PFIZER · Nov 9, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating an experimental drug called PF-08046050, which is designed to treat adults with advanced solid tumors, including types of cancer like colorectal, stomach, pancreatic, and lung cancers. Participants in this study must have solid tumors that have either come back after treatment or did not respond to standard treatments and cannot be treated with conventional drugs. The trial is divided into three parts: the first two parts will determine the right dosage for the drug, while the third part will assess how safe it is and if it effectively treats these difficult-to-treat cancers.

To be eligible for this trial, participants need to have a confirmed diagnosis of specific cancer types, have previously tried certain treatments, and have tumors that can be accessed for testing. Participants can expect to receive careful monitoring and support throughout the study, which aims to find a new option for patients whose cancer is not responding to existing therapies. It's important to note that this trial is currently recruiting and is open to both men and women aged 65 and older.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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 and must have received prior treatment (in 1 or more lines of therapy) containing fluoropyrimidine, oxaliplatin, and irinotecan.
• • PDAC and must have received 1 prior line of therapy and received no more than 3 prior lines of therapy in the advanced or metastatic setting.
• • 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.
• • Participants in Part D (bevacizumab combination therapy dose escalation) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must have demonstrated progressive disease or intolerance to their last treatment regimen. Prior treatment regimens must have included fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and/or an anti-EGFR monoclonal antibody for RAS wildtype participants.
• • Participants in Part E (bevacizumab combination therapy dose expansion) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum. Must have received a maximum of 2 prior chemotherapy regimens for the treatment of advanced CRC and had demonstrated progressive disease or intolerance to their last regimen. Prior treatment regimens must have included a fluoropyrimidine, irinotecan, oxaliplatin, an anti-VEGF monoclonal antibody and/or an anti-EGFR monoclonal antibody for RAS wildtype participants.
• 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 bevacizumab 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 an antibody-drug conjugate (ADC) with a camptothecin payload
• • 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