A Study of SGN-CD228A in Advanced Solid Tumors

  • Interventional
  • Recruiting
  • NCT04042480
Eligibility Details Visit Clinicaltrials.gov

A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors

This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.

This study is designed to evaluate the safety, tolerability, PK, and antitumor activity of SGN-CD228A in select advanced solid tumors. The study will include dose escalation and dose expansion, with multiple disease-specific expansion cohorts.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria

         - Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below. Participants must have relapsed, refractory, or progressive disease (PD) and should have no appropriate standard therapy available.

         - Dose escalation

             - Advanced cutaneous melanoma

             - Malignant pleural mesothelioma (MPM)

             - Advanced HER2-negative breast cancer

             - Advanced non-small cell lung cancer (NSCLC)

             - Advanced colorectal cancer

             - Advanced pancreatic ductal adenocarcinoma (PDAC)

         - Disease-specific dose expansion

             - Metastatic or advanced cutaneous melanoma: Excludes acral or mucosal varieties. Participants must have received at least 1 PD-1-targeted therapy unless contraindicated. Participants with targetable mutations should have received at least 1 therapy targeting that mutation unless contraindicated.

             - MPM: Participants must have received cisplatin and pemetrexed unless contraindicated.

             - Advanced HER2- breast cancer: Participants must have received 1 or more prior lines of therapy for locally advanced or metastatic disease. Prior therapies must include taxane. Hormone-receptor-positive subjects should have received CDK4/6 inhibitor therapy and have received at least 1 prior hormonally-directed therapy, unless contraindicated.

             - Advanced NSCLC: Participants must have locally advanced or metastatic EGFR wild-type NSCLC. Participants must have received platinum-based therapy and at least 1 PD-1- or PD-L1-targeted therapy unless contraindicated.

             - Advanced colorectal cancer: Participants must have received 2 or more prior lines of therapy for locally advanced or metastatic disease, including targeted therapies as appropriate.

             - PDAC: Participants must have unresectable or advanced PDAC. Participants must have received 1 or more prior line of therapy for locally advanced or metastatic disease unless contraindicated.

         - Participants should be able to provide adequate tumor tissue for biomarker analysis

         - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

         - Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1) at baseline

        Exclusion Criteria

         - 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.

         - Pre-existing neuropathy Grade 2 or greater

         - Retinal or macular disease requiring treatment or ongoing active monitoring

         - Prior receipt of SGN228A or MMAE-containing agents

At a Glance

National Government IDNCT04042480

IRB#IRB20-0465

Lead SponsorSeagen Inc.

Lead PhysicianHedy Kindler

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting