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

Registration Number
NCT06254495
Lead Sponsor
Seagen Inc.
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).
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Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
170
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)

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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.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
SGN-35CSGN-35CSGN-35C Monotherapy
Primary Outcome Measures
NameTimeMethod
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 abnormalitiesThrough 30-37 days after last study treatment, approximately 1 year
Number of participants with DLTs by dose levelUp to 21 days
Number of participants with dose modifications due to AEsUp to approximately 1 year
Number of participants with dose-limiting toxicities (DLTs)Up to 21 days
Secondary Outcome Measures
NameTimeMethod
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 investigatorUp 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 investigatorUp 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 (9)

Rigshospitalet University Hospital of Copenhagen

🇩🇰

Copenhagen, Other, Denmark

City of Hope

🇺🇸

Duarte, California, United States

UC San Diego / Moores Cancer Center

🇺🇸

La Jolla, California, United States

University of California, San Francisco | HDFCCC - Hematopoietic Malignancies

🇺🇸

San Francisco, California, United States

University of Miami

🇺🇸

Miami, Florida, United States

University of Kansas Cancer Center

🇺🇸

Fairway, Kansas, United States

University of Nebraska Medical Center

🇺🇸

Omaha, Nebraska, United States

Fred Hutchinson Cancer Research Center | Seattle, WA

🇺🇸

Seattle, Washington, United States

Centro Ricerche Cliniche di Verona s.r.l.

🇮🇹

Verona, Other, Italy

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