Hodgkin Disease, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Anaplastic, Lymphoma, T-Cell, Peripheral
Conditions
Keywords
cHL, PTCL, sALCL, DLBCL, Seattle Genetics, ADC, Anti Drug Conjugate
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.
Interventions
DRUGPF-08046044/SGN-35C
Given into the vein (IV; intravenously)
Sponsors
Seagen, a wholly owned subsidiary of Pfizer
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with antidrug antibodies (ADA) | Through 30-37 days after last study treatment, approximately 1 year | To be summarized using descriptive statistics |
| Area under the concentration time curve (AUC) | 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 |
| 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. |
| CR rate as assessed by the investigator | Up to approximately 1 year | CR rate is defined as the proportion of participants with CR. |
| 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. |
Countries
Denmark, France, Italy, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed