A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors
An Open-label Phase 1 Study to Investigate PF-08046050 (SGN-CEACAM5C) in Adults With Advanced Solid Tumors
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety, dose, and cancer-fighting effects of PF-08046050, an experimental drug, alone or with other cancer drugs. It is for adults with certain solid tumors that have spread or cannot be removed by surgery. The cancer types and past treatments allowed depend on the study part.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have a solid tumor confirmed by a tissue or cell test that has spread or cannot be removed by surgery.
- Parts A and B include certain colon, rectal, stomach, lung, or pancreatic cancers. The cancer must have returned, resisted treatment, or worsened, with no suitable standard treatment available.
- Part C includes certain colon, rectal, pancreatic, stomach, or lung cancers. Each group has rules about which treatments you must have tried and how many you may have had.
- Parts D and E include colon or rectal cancer groups with different past-treatment rules. Some groups allow no past chemotherapy for advanced cancer; others allow one or two courses of treatment. Some do not allow past drugs such as irinotecan.
- Part E also includes pancreatic cancer that has spread and can be measured on scans. One group requires no prior treatment for cancer that has spread, with a limited exception for chemotherapy given around surgery.
- Some groups in Parts B, C, and E require a tumor that can be reached for a biopsy, where a small tissue sample is taken. You must agree to provide new samples and/or stored tumor tissue.
- Be fully active or able to walk and do light work, even if hard physical activity is limited.
- Have cancer that can be measured using the study's rules before treatment starts.
Who can't join
- Past treatment aimed at CEACAM5, a target on cancer cells.
- Past treatment with a TOPO1-targeting antibody-drug conjugate, a drug that carries chemotherapy to cells, such as Enhertu or Trodelvy.
- Another cancer within the past 3 years, or cancer still present from an earlier diagnosis.
- Active cancer in the brain or its coverings. Treated, stable disease may be allowed if you have no ongoing related side effects and have not needed steroids for related symptoms for at least 2 weeks.
- For bevacizumab groups in Parts D and E: allergy to bevacizumab, its ingredients, products made using Chinese hamster ovary cells, or certain lab-made human-like antibodies.
- For bevacizumab groups: a serious wound, open sore, or broken bone that has not healed.
- For bevacizumab groups: a blood clot in a deep vein within the past 4 weeks, or a blood-clotting problem that raises bleeding risk.
- For bevacizumab groups: a past life-threatening side effect linked to VEGF, a protein involved in blood vessel growth.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 (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
Study sites (21)
AZ
- Mayo Clinic Hospital · Phoenix, AZ 85054More trials in Phoenix
- Mayo Clinic · Scottsdale, AZ 85259More trials in Scottsdale
CA
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) · Duarte, CA 91010More trials in Duarte
- IP Address: City of Hope Investigational Drug Services(IDS) · Duarte, CA 91010More trials in Duarte
CO
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) · Aurora, CO 80045More trials in Aurora
- University of Colorado Hospital · Aurora, CO 80045More trials in Aurora
FL
- Florida Cancer Specialists · Orlando, FL 32827More trials in Orlando
- Sarah Cannon Research Institute at Florida Cancer Specialists · Orlando, FL 32827More trials in Orlando
MA
- Beth Israel Deaconess Medical Center · Boston, MA 02215More trials in Boston
MD
- Sidney Kimmel Comprehensive Cancer at Johns Hopkins · Baltimore, MD 21287More trials in Baltimore
MI
- START Midwest · Grand Rapids, MI 49546More trials in Grand Rapids
MN
- Mayo Clinic Cancer Center · Rochester, MN 55905More trials in Rochester
- Mayo Clinic · Rochester, MN 55905More trials in Rochester
MO
- MidAmerica Cancer Care · Kansas City, MO 64132More trials in Kansas City
TN
- Sarah Cannon Research Institute - Pharmacy · Nashville, TN 37203More trials in Nashville
- SCRI Oncology Partners · Nashville, TN 37203More trials in Nashville
TX
- The University of Texas MD Anderson Cancer Center · Houston, TX 77030More trials in Houston
- NEXT Dallas · Irving, TX 75039More trials in Irving
- South Texas Accelerated Research Therapeutics, LLC · San Antonio, TX 78229More trials in San Antonio
UT
- START Mountain Region · Salt Lake City, UT 84119More trials in Salt Lake City
- South Texas Accelerated Research Therapeutics Mountain Region · West Valley City, UT 84119More trials in West Valley City