A Safety Study of PF-08046044/SGN-35C in Adults With Advanced Cancers
- Conditions
- Lymphoma, T-Cell, PeripheralLymphoma, Large B-Cell, DiffuseHodgkin DiseaseLymphoma, Large-Cell, Anaplastic
- Interventions
- Drug: PF-08046044/SGN-35C
- Registration Number
- NCT06254495
- Lead Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Brief Summary
This clinical trial is studying lymphoma. Lymphoma is a cancer that starts in the blood cells that fight infection. There are several types of lymphoma. This study will enroll people who have classical Hodgkin lymphoma (cHL), peripheral T cell lymphoma (PTCL), or diffuse large B cell lymphoma (DLBCL).
This clinical trial uses a drug called PF-08046044/SGN-35C . The study drug is in testing and has not been approved for sale. This is the first time SGN -35C will be used in people.
This study will test the safety of SGN-35C in participants with lymphoma. It will also study the side effects of this drug. A side effect is anything a drug does to the body besides treating the disease.
This study will have three parts. Parts A and B of the study will find out the best dose and dosing schedule for SGN-35C. Part C will use the dose found in parts A and B to find out how safe SGN-35C is and if it works to treat select lymphomas.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 210
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Tumor type
-
For dose escalation and back fill and dose optimization (Parts A and B):
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Participants with a histologically confirmed lymphoid neoplasm who in the judgement of the investigator have no appropriate standard therapy available at the time of enrollment and are a candidate for PF-08046044/SGN- 35C treatment. Eligible subtypes and treatment status are as follows:
- Participants with relapsed/refractory (R/R) cHL: should have received at least 3 prior systemic therapies including autologous stem cell transplant [ASCT] (ASCT and the associated high-dose chemotherapy prior to ASCT are considered to be 1 prior line, along with post-transplant consolidation if progression has not occurred between transplant and start of consolidation) or an anti-PD-1 agent (or refused/were ineligible); or 2 prior systemic therapies if, according to the investigator, no other appropriate standard treatment is available.
- Participants with R/R PTCL (excluding systematic anaplastic large cell lymphoma [sALCL]): should have received at least 2 prior systemic therapies, or 1 prior systemic therapy if, according to the investigator, no other appropriate standard treatment is available.
- Participants with R/R sALCL: should have received at least 2 prior systemic therapies, including 1 brentuximab vedotin-containing regimen, or 1 prior line of systemic therapy including brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone.
- Participants with R/R DLBCL: should have received at least 2 prior systemic therapies, including ASCT and chimeric antigen receptor (CAR) T-cell therapy, or were ineligible, or refused.
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Participants with PTCL and DLBCL must have a detectable cluster of differentiation 30 (CD30) expression level (≥1%) in tumor tissue from the most recent biopsy obtained at or after relapse by local testing.
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For dose expansion (Part C):
- Participants are eligible irrespective of CD30 expression on tumor tissue; however, participants must provide tumor tissue for evaluation of CD30 expression from the most recent biopsy obtained at or after relapse.
- Participants with cHL, PTCL, sALCL, and DLBCL: Eligible subtypes are the same as defined in Parts A and B
- If activated, the biology cohort may enroll the populations included in Parts A, B, and C.
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Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1
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Fluorodeoxyglucose positron emission tomography (FDG-PET) avid and bidimensional measurable disease as documented by radiographic technique (spiral computed tomography [CT] preferred)
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Previous exposure to any antibody-drug conjugates (ADCs) with camptothecin-based payload.
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History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death
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Active central nervous system (CNS) disease related to the underlying malignancy. Participants with a history of CNS disease related to the underlying malignancy are allowed if prior CNS disease has been treated and the participant is clinically stable (defined as not currently receiving steroid treatment for symptoms related to cerebral/meningeal disease and with no ongoing related AE).
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Received previous ASCT infusion <12 weeks prior to the first dose of SGN-35C.
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Previous allogeneic stem cell transplant (SCT) if they meet any of the following criteria:
- <100 days from allogeneic SCT. Participants ≥100 days from allogeneic SCT who are stable without immunosuppressive therapy for at least 12 weeks are permitted.
- Active acute or chronic graft-versus-host disease (GVHD) or receiving immunosuppressive therapy as treatment for or prophylaxis against GVHD.
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History of clinically significant GI bleeding, intestinal obstruction, or GI perforation within 6 months of initiation of trial treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description PF-08046044/SGN-35C PF-08046044/SGN-35C PF-08046044/SGN-35C Monotherapy
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Through 30-37 days after last study treatment, approximately 1 year An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention
Number of participants with laboratory abnormalities Through 30-37 days after last study treatment, approximately 1 year Number of participants with dose modifications due to AEs Up to approximately 1 year Number of participants with dose-limiting toxicities (DLTs) Up to 21 days Number of participants with DLTs by dose level Up to 21 days
- Secondary Outcome Measures
Name Time Method Number of participants with antidrug antibodies (ADA) Through 30-37 days after last study treatment, approximately 1 year To be summarized using descriptive statistics
Maximum concentration (Cmax) Through 30-37 days after last study treatment, approximately 1 year To be summarized using descriptive statistics
CR rate as assessed by the investigator Up to approximately 1 year CR rate is defined as the proportion of participants with CR.
Area under the concentration time curve (AUC) Through 30-37 days after last study treatment, approximately 1 year To be summarized using descriptive statistics
Time at which the maximum concentration occurs (Tmax) Through 30-37 days after last study treatment, approximately 1 year To be summarized using descriptive statistics
Apparent terminal half-life (t1/2) Through 30-37 days after last study treatment, approximately 1 year To be summarized using descriptive statistics
Trough concentration (Ctrough) Through 30-37 days after last study treatment, approximately 1 year To be summarized using descriptive statistics
Objective response rate (ORR) as assessed by the investigator Up to approximately 1 year A participant is determined to have an objective response if, based on Lugano criteria (Cheson 2014), they achieve a complete response (CR) or partial response (PR) as assessed by the investigator. The ORR is defined as the percentage of participants with an objective response.
Duration of response (DOR) Up to approximately 1 year DOR is defined as the time from the start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per Lugano criteria (Cheson 2014) as assessed by the investigator or to death due to any cause, whichever comes first.
Trial Locations
- Locations (42)
The University of Kansas Hospital Cambridge Tower A
🇺🇸Kansas City, Kansas, United States
The University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
The University of Kansas Medical Center Medical Office Building
🇺🇸Kansas City, Kansas, United States
The University of Kansas Cancer Center - Overland Park
🇺🇸Overland Park, Kansas, United States
The University of Kansas Cancer Center - Indian Creek Campus
🇺🇸Overland Park, Kansas, United States
University of Kansas Cancer Center
🇺🇸Westwood, Kansas, United States
The University of Kansas Cancer Center - Lee's Summit
🇺🇸Lee's Summit, Missouri, United States
Nebraska Medicine - Bellevue Medical Center
🇺🇸Bellevue, Nebraska, United States
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Nebraska Medicine - Village Pointe
🇺🇸Omaha, Nebraska, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Fred Hutchinson Cancer Research Center | Seattle, WA
🇺🇸Seattle, Washington, United States
University of Washington
🇺🇸Seattle, Washington, United States
Rigshospitalet University Hospital of Copenhagen
🇩🇰Copenhagen Ø, Denmark
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States
Charite Universitatsmedizin berlin
🇩🇪Berlin, Germany
UC San Diego / Moores Cancer Center
🇺🇸La Jolla, California, United States
City of Hope (City of Hope National Medical Center, City Of Hope Medical Center)
🇺🇸Duarte, California, United States
Labor Berlin - Charite Vivantes GmbH
🇩🇪Berlin, Germany
City of Hope
🇺🇸Duarte, California, United States
IP Address: City of Hope Investigational Drug Services(IDS)
🇺🇸Duarte, California, United States
Centro Ricerche Cliniche di Verona s.r.l.
🇮🇹Verona, Italy
UCSD Medical Center - Encinitas
🇺🇸Encinitas, California, United States
UC San Diego/Moores Cancer Center
🇺🇸La Jolla, California, United States
UCSD Koman Family Outpatient Pavilion
🇺🇸La Jolla, California, United States
UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
🇺🇸La Jolla, California, United States
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
UC San Diego Medical Center - Hillcrest
🇺🇸San Diego, California, United States
The Royal Marsden NHS Foundation Trust (RM)
🇬🇧London, United Kingdom
UCSD Medical Center - Rancho Bernardo
🇺🇸San Diego, California, United States
UCSD Medical Center - Vista
🇺🇸Vista, California, United States
University of California San Francisco | HDFCCC - Hematopoietic Malignancies
🇺🇸San Francisco, California, United States
University of California, San Francisco | HDFCCC - Hematopoietic Malignancies
🇺🇸San Francisco, California, United States
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
🇺🇸Coral Gables, Florida, United States
University of Miami Hospital and Clinics - Deerfield Beach
🇺🇸Deerfield Beach, Florida, United States
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Sylvester Comprehensive Cancer Center - Hollywood
🇺🇸Hollywood, Florida, United States
University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Sylvester Comprehensive Cancer Center - Kendall
🇺🇸Miami, Florida, United States
The University of Kansas Cancer Center, Investigational Drug Services
🇺🇸Fairway, Kansas, United States
University of Kansas Clinical Research Center
🇺🇸Fairway, Kansas, United States
University Of Miami Hospitals And Clinics
🇺🇸Miami, Florida, United States