Clinical trial NCT06254495: A Safety Study of PF-08046044/SGN-35C in Adults With Advanced Cancers
Official title: A Phase 1, Open-label Study to Evaluate PF-08046044/SGN-35C in Adults With Advanced Malignancies.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hodgkin Disease
Lymphoma, T-Cell, Peripheral
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Anaplastic
Keywords: cHL
PTCL
sALCL
DLBCL
Seattle Genetics
ADC
Anti Drug Conjugate
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-12
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Tumor type
* For dose escalation and back fill and dose optimization (Parts A and B):

  * 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.
  * 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.
* 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.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of ≤1
* Fluorodeoxyglucose positron emission tomography (FDG-PET) avid and bidimensional measurable disease as documented by radiographic technique (spiral computed tomography \[CT\] preferred)

Exclusion Criteria:

* Previous exposure to any antibody-drug conjugates (ADCs) with camptothecin-based payload.
* 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
* 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).
* Received previous ASCT infusion \<12 weeks prior to the first dose of SGN-35C.
* 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.
* History of clinically significant GI bleeding, intestinal obstruction, or GI perforation within 6 months of initiation of trial treatment.

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Through 30-37 days after last study treatment, approximately 1 year
measure: Number of participants with laboratory abnormalities
timeFrame: Through 30-37 days after last study treatment, approximately 1 year
measure: Number of participants with dose modifications due to AEs
timeFrame: Up to approximately 1 year
measure: Number of participants with dose-limiting toxicities (DLTs)
timeFrame: Up to 21 days
measure: Number of participants with DLTs by dose level
timeFrame: Up to 21 days
Secondary outcomes:
measure: Number of participants with antidrug antibodies (ADA)
timeFrame: Through 30-37 days after last study treatment, approximately 1 year
measure: Area under the concentration time curve (AUC)
timeFrame: Through 30-37 days after last study treatment, approximately 1 year
measure: Maximum concentration (Cmax)
timeFrame: Through 30-37 days after last study treatment, approximately 1 year
measure: Time at which the maximum concentration occurs (Tmax)
timeFrame: Through 30-37 days after last study treatment, approximately 1 year
measure: Apparent terminal half-life (t1/2)
timeFrame: Through 30-37 days after last study treatment, approximately 1 year
measure: Trough concentration (Ctrough)
timeFrame: Through 30-37 days after last study treatment, approximately 1 year
measure: Objective response rate (ORR) as assessed by the investigator
timeFrame: Up to approximately 1 year
measure: CR rate as assessed by the investigator
timeFrame: Up to approximately 1 year
measure: Duration of response (DOR)
timeFrame: Up to approximately 1 year
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope (City of Hope National Medical Center, City Of Hope Medical Center)
state: California
city: Duarte
country: United States
facility: IP Address: City of Hope Investigational Drug Services(IDS)
state: California
city: Encinitas
country: United States
facility: UCSD Medical Center - Encinitas
state: California
city: La Jolla
country: United States
facility: UC San Diego / Moores Cancer Center
state: California
city: La Jolla
country: United States
facility: UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)
state: California
city: La Jolla
country: United States
facility: UC San Diego/Moores Cancer Center
state: California
city: La Jolla
country: United States
facility: UCSD Koman Family Outpatient Pavilion
state: California
city: San Diego
country: United States
facility: UC San Diego Medical Center - Hillcrest
state: California
city: San Diego
country: United States
facility: UCSD Medical Center - Rancho Bernardo
state: California
city: San Francisco
country: United States
facility: University of California San Francisco | HDFCCC - Hematopoietic Malignancies
state: California
city: Vista
country: United States
facility: UCSD Medical Center - Vista
state: California
city: Coral Gables
country: United States
facility: Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
state: Florida
city: Deerfield Beach
country: United States
facility: University of Miami Hospital and Clinics - Deerfield Beach
state: Florida
city: Hollywood
country: United States
facility: Sylvester Comprehensive Cancer Center - Hollywood
state: Florida
city: Miami
country: United States
facility: University Of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center
state: Florida
city: Miami
country: United States
facility: University Of Miami Hospitals And Clinics
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center - Kendall
state: Florida
city: Fairway
country: United States
facility: The University of Kansas Cancer Center, Investigational Drug Services
state: Kansas
city: Fairway
country: United States
facility: University of Kansas Clinical Research Center
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Hospital Cambridge Tower A
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Hospital
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Medical Center Medical Office Building
state: Kansas
city: Overland Park
country: United States
facility: The University of Kansas Cancer Center - Overland Park
state: Kansas
city: Overland Park
country: United States
facility: The University of Kansas Cancer Center - Indian Creek Campus
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Lee's Summit
country: United States
facility: The University of Kansas Cancer Center - Lee's Summit
state: Missouri
city: Bellevue
country: United States
facility: Nebraska Medicine - Bellevue Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska Medicine - Village Pointe
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center | Seattle, WA
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Copenhagen Ø
country: Denmark
facility: Rigshospitalet University Hospital of Copenhagen
city: Caen
country: France
facility: Centre Hospitalier Universitaire (CHU) de Caen
city: Montpellier
country: France
facility: CHU Montpellier
city: Pierre-Benite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Villejuif Cedex
country: France
facility: Institut Gustave Roussy
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Verona
country: Italy
facility: Centro Ricerche Cliniche di Verona s.r.l.
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: London
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust (RM)
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: