ACTIVE_NOT_RECRUITING

A Safety Study of PF-08046044/SGN-35C in Adults With Advanced Cancers

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Conditions

Hodgkin DiseaseLymphoma, T-Cell, PeripheralLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, AnaplasticcHLPTCLsALCLDLBCLSeattle GeneticsADCAnti Drug Conjugate

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1, Open-label Study to Evaluate PF-08046044/SGN-35C in Adults With Advanced Malignancies.

Quick Facts

Study Start:2024-05-28
Study Completion:2029-04-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06254495

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Tumor type
  2. * For dose escalation and back fill and dose optimization (Parts A and B):
  3. * 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:
  4. * 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.
  5. * 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.
  6. * 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.
  7. * 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.
  8. * 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.
  9. * For dose expansion (Part C):
  10. * 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.
  11. * Participants with cHL, PTCL, sALCL, and DLBCL: Eligible subtypes are the same as defined in Parts A and B
  12. * If activated, the biology cohort may enroll the populations included in Parts A, B, and C.
  13. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1
  14. * Fluorodeoxyglucose positron emission tomography (FDG-PET) avid and bidimensional measurable disease as documented by radiographic technique (spiral computed tomography \[CT\] preferred)
  1. * Previous exposure to any antibody-drug conjugates (ADCs) with camptothecin-based payload.
  2. * 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
  3. * 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).
  4. * Received previous ASCT infusion \<12 weeks prior to the first dose of SGN-35C.
  5. * Previous allogeneic stem cell transplant (SCT) if they meet any of the following criteria:
  6. * \<100 days from allogeneic SCT. Participants ≥100 days from allogeneic SCT who are stable without immunosuppressive therapy for at least 12 weeks are permitted.
  7. * Active acute or chronic graft-versus-host disease (GVHD) or receiving immunosuppressive therapy as treatment for or prophylaxis against GVHD.
  8. * History of clinically significant GI bleeding, intestinal obstruction, or GI perforation within 6 months of initiation of trial treatment.

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

City of Hope (City of Hope National Medical Center, City Of Hope Medical Center)
Duarte, California, 91010
United States
IP Address: City of Hope Investigational Drug Services(IDS)
Duarte, California, 91010
United States
University of California San Francisco | HDFCCC - Hematopoietic Malignancies
San Francisco, California, 94143
United States
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables, Florida, 33146
United States
University of Miami Hospital and Clinics - Deerfield Beach
Deerfield Beach, Florida, 33442
United States
Sylvester Comprehensive Cancer Center - Hollywood
Hollywood, Florida, 33021
United States
University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
University Of Miami Hospitals And Clinics
Miami, Florida, 33136
United States
Sylvester Comprehensive Cancer Center - Kendall
Miami, Florida, 33176
United States
The University of Kansas Cancer Center, Investigational Drug Services
Fairway, Kansas, 66205
United States
University of Kansas Clinical Research Center
Fairway, Kansas, 66205
United States
The University of Kansas Hospital Cambridge Tower A
Kansas City, Kansas, 66160
United States
The University of Kansas Hospital
Kansas City, Kansas, 66160
United States
The University of Kansas Medical Center Medical Office Building
Kansas City, Kansas, 66160
United States
The University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, 66210
United States
The University of Kansas Cancer Center - Indian Creek Campus
Overland Park, Kansas, 66211
United States
University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
The University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, 64064
United States
Nebraska Medicine - Bellevue Medical Center
Bellevue, Nebraska, 68123
United States
Nebraska Medical Center
Omaha, Nebraska, 68105
United States
Nebraska Medicine - Village Pointe
Omaha, Nebraska, 68118
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Fred Hutchinson Cancer Research Center | Seattle, WA
Seattle, Washington, 98109
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-28
Study Completion Date2029-04-18

Study Record Updates

Study Start Date2024-05-28
Study Completion Date2029-04-18

Terms related to this study

Keywords Provided by Researchers

  • cHL
  • PTCL
  • sALCL
  • DLBCL
  • Seattle Genetics
  • ADC
  • Anti Drug Conjugate

Additional Relevant MeSH Terms

  • Hodgkin Disease
  • Lymphoma, T-Cell, Peripheral
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Large-Cell, Anaplastic