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

Lymphoma, Large B-Cell, Diffuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06254495
• Other study ID #: SGN35C-001
• Status: Recruiting
• Phase: Phase 1
• Start date: May 31, 2024
• Est. completion date: August 31, 2028

Study information

• Verified date: April 2024
• Source: Seagen Inc.
• Contact: Seagen Trial Information Support
• Phone: 866-333-7436
• Email: clinicaltrials[@]seagen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: August 31, 2028
• Est. primary completion date: February 28, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Tumor type

• For dose escalation 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 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) 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 cerebral/meningeal disease related to the underlying malignancy

• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• SGN-35C
Given into the vein (IV; intravenously)

Locations

Country	Name	City	State
United States	City of Hope	Duarte	California

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)	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	Through 30-37 days after last study treatment, approximately 1 year
Primary	Number of participants with laboratory abnormalities		Through 30-37 days after last study treatment, approximately 1 year
Primary	Number of participants with dose modifications due to AEs		Up to approximately 1 year
Primary	Number of participants with dose-limiting toxicities (DLTs)		Up to 21 days
Primary	Number of participants with DLTs by dose level		Up to 21 days
Secondary	Number of participants with antidrug antibodies (ADA)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, approximately 1 year
Secondary	Area under the concentration time curve (AUC)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, approximately 1 year
Secondary	Maximum concentration (Cmax)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, approximately 1 year
Secondary	Time at which the maximum concentration occurs (Tmax)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, approximately 1 year
Secondary	Apparent terminal half-life (t1/2)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, approximately 1 year
Secondary	Trough concentration (Ctrough)	To be summarized using descriptive statistics	Through 30-37 days after last study treatment, approximately 1 year
Secondary	Objective response rate (ORR) as assessed by the investigator	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.	Up to approximately 1 year
Secondary	CR rate as assessed by the investigator	CR rate is defined as the proportion of participants with CR.	Up to approximately 1 year
Secondary	Duration of response (DOR)	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.	Up to approximately 1 year