Clinical trial for Colorectal Neoplasms
Official title A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06131840
What this study is testing
What is PF-08046050?
An investigational intravenous antibody‑drug conjugate being studied for advanced solid tumors such as colorectal cancer. It is designed to target cancer cells and deliver a toxic payload to kill them.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the safest dose of PF-08046050 and see if it can help treat certain solid tumors that are hard to treat or have spread.
- Who it's for
- Adults whose solid tumors have returned or did not improve after standard treatments and cannot be treated with usual drugs.
- What's involved
- Participants will receive the experimental drug and have regular visits and tests to monitor safety and effectiveness.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or...
- Participants in Part A must have one of the following tumor types: colorectal cancer (CRC)
- 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...
- CRC (adenocarcinoma of the colon or rectum) and must have received no more than 2 prior chemotherapy regimens for the treatment of advanced...
You likely can't join if
- Previous exposure to CEACAM5-targeted therapy.
- Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).
- History of another malignancy within 3 years before the first dose of study intervention, or any evidence of residual disease from a previously...
- Active cerebral/meningeal disease related to the underlying malignancy.
- History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.
- History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
See the full eligibility criteria
- Participants in Part A (dose escalation) and Part B (dose optimization) must have histologically- or cytologically-confirmed metastatic or unresectable solid tumor malignancy.
- 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)
- 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...
- PDAC with one or more metastatic lesions measurable by computed tomography/magnetic resonance imaging according to RECIST v1.1 criteria
- 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.
- 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.
- CRC participants in Part D and Part E (bevacizumab combination therapy) must have histologically confirmed unresectable or metastatic adenocarcinoma of the colon or rectum.
- 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...
- Monotherapy dose optimization (Part B)
- Monotherapy (Part C) and combination therapy (Part E) disease-specific expansion cohorts
- An Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
- Measurable disease per Response Evaluation in Solid Tumors (RECIST) v1.1 at baseline.
- Previous exposure to CEACAM5-targeted therapy.
- Prior treatment with a TOPO1-targeting ADC (CPT payload), such as Enhertu (trastuzumab deruxtecan) or Trodelvy (sacituzumab govitecan).
- 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.
- 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...
- History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients.
- History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
- Serious non-healing wound, non-healing ulcer, or non-healing bone fracture.
- Deep venous thromboembolic event within 4 weeks prior to enrollment
- Known coagulopathy that increases risk of bleeding, bleeding diatheses.
- History of any life-threatening VEGF-related adverse event
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Duarte, California, United States
- Aurora, Colorado, United States
- Orlando, Florida, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- Rochester, Minnesota, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
- West Valley City, Utah, United States
- Ottawa, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Guangzhou, Guangdong, China
- Villejuif, Paris, France
- Villejuif, France
+ 13 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Duarte, California, United States; Aurora, Colorado, United States; Orlando, Florida, United States; Baltimore, Maryland, United States and 27 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.