A Study of SGN-CD228A in Advanced Solid Tumors

Seagen

Status and phase

Terminated

Phase 1

Conditions

Pleural Mesothelioma

Non-small Cell Lung Cancer

HER2 Negative Breast Neoplasms

Pancreatic Ductal Adenocarcinoma

Colorectal Cancer

Cutaneous Melanoma

Treatments

Drug: SGN-CD228A

Study type

Interventional

Funder types

Industry

Identifiers

NCT04042480

SGN228-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

88 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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. Disease-specific escalation/expansion includes the following tumor types.
- Metastatic cutaneous melanoma(MCM):
  - 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.
- Malignant pleural mesothelioma (MPM):
  - Participants must have received cisplatin and pemetrexed unless contraindicated.
- Advanced HER2-negative 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 non-small cell lung cancer (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 as a single agent or as part of a combination 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.
- Advanced pancreatic ductal adenocarcinoma (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)

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 SGN-CD228A or MMAE-containing agents