A Study of SGN-STNV in Advanced Solid Tumors

Seagen

Status and phase: Terminated; Phase 1

Conditions: Uterine Cervical Neoplasms; Ovarian Neoplasms; Gastroesophageal Junction Carcinoma; Esophageal Neoplasms; Endometrial Neoplasms; Exocrine Pancreatic Adenocarcinoma; Appendiceal Adenocarcinoma; Carcinoma, Non-Small Cell Lung; HER2 Negative Breast Neoplasms; Colorectal Neoplasms; Stomach Neoplasms; Pseudomyxoma Peritonei

Treatments: Drug: SGN-STNV

Study type: Interventional

Funder types: Industry

Identifiers

NCT04665921

SGNSTNV-001

Details and patient eligibility

About

This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors.

The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.

Full description

The study will include dose escalation (Part A) and dose expansion (Part B), with multiple disease-specific cohorts and a biology cohort in dose expansion. The biology cohort will require additional biopsies. At the completion of dose escalation, up to 5 disease specific expansion cohorts and 1 biology expansion cohort may be activated by the sponsor in consultation with the Safety Monitoring Committee (SMC). Expansion cohorts in Part B will enroll subjects with selected tumors that are eligible for enrollment in Part A. The dose(s) to be examined in Part B will be at or below the maximum tolerated dose and/or the recommended dose determined in Part A. The recommended dose and/or schedule may differ between cohorts.

Enrollment: 111 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Disease indication

  • Must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic option.

    • Non-small cell lung cancer (NSCLC)
    • HER2 negative breast cancer
    • Ovarian cancer
    • Cervical cancer
    • Endometrial cancer
    • Esophageal cancer
    • Gastric cancer and GEJ carcinoma
    • Colorectal cancer
    • Exocrine pancreatic adenocarcinoma
    • Appendiceal adenocarcinoma and pseudomyxoma peritonei of unknown origin

• Participants enrolled in the following study parts should have an appropriate tumor site that satisfies the following criteria:

  • Site has tumor that is not a target lesion and has not been previously irradiated (unless progression has occurred since end of radiotherapy)

  • Site has tumor that is accessible for a minimally invasive biopsy that does not present a significant risk, AND

  • Participant must agree to a biopsy as follows

    • Disease-specific expansion cohorts: pre-treatment biopsy, unless medically infeasible following consultation with the medical monitor
    • Biology expansion cohort: pretreatment biopsy (required) and additional on-treatment biopsy during Cycle 1 (unless medically infeasible following consultation with the medical monitor)

• Measurable disease per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) at baseline

• An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

• Adequate renal, hepatic, and hematologic function

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.
• Known active central nervous system metastases
• Carcinomatous meningitis
• Previous receipt of monomethylauristatin E (MMAE)-containing drugs
• Pre-existing neuropathy ≥ Grade 2 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
• Any uncontrolled ≥ Grade 3 (per the NCI CTCAE, Version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of SGN-STNV

There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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111 participants in 1 patient group

SGN-STNV

Experimental group

Description:

SGN-STNV monotherapy

Treatment:

Drug: SGN-STNV