Appendiceal Adenocarcinoma, Carcinoma, Non-Small Cell Lung, Colorectal Neoplasms, Endometrial Neoplasms, Esophageal Neoplasms, Exocrine Pancreatic Adenocarcinoma, Gastroesophageal Junction Carcinoma, HER2 Negative Breast Neoplasms, Ovarian Neoplasms, Pseudomyxoma Peritonei, Stomach Neoplasms, Uterine Cervical Neoplasms
Conditions
Keywords
NSCLC, Non-Small Cell Lung Cancer, HER2-Negative Breast Cancer, High-Grade Serous Ovarian Cancer, HGSOC, Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Esophageal Cancer, Gastric Cancer, GEJ Carcinoma, Colorectal Cancer, Seattle Genetics
Brief summary
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.
Detailed 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.
Interventions
DRUGSGN-STNV
Given into the vein (IV; intravenously)
Sponsors
Seagen Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | To be summarized using descriptive statistics |
| Incidence of laboratory abnormalities | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | To be summarized using descriptive statistics |
| Incidence of dose limiting toxicities | Up to 28 days | To be summarized using descriptive statistics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of objective response (DOR) | Up to approximately 3 years | DOR is defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or to death due to any cause, whichever comes first. |
| Area under the concentration-time curve (AUC) | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | Pharmacokinetic (PK) endpoint |
| Time to maximum concentration (Tmax) | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | PK endpoint |
| Objective response rate (ORR) as assessed by the investigator per RECIST v1.1 | Up to approximately 3 years | ORR is defined as the proportion of subjects achieving a partial response (PR) or complete response (CR). |
| Trough concentration (Ctrough) | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | PK endpoint |
| Incidence of antidrug antibodies (ADA) | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | Immunogenicity endpoint |
| Maximum concentration (Cmax) | Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years | PK endpoint |
| Progression-free survival (PFS) | Up to approximately 3 years | PFS is defined as the time from the start of any study treatment to first documentation of disease progression or to death due to any cause, whichever comes first. |
| Overall survival (OS) | Up to approximately 3 years | OS is defined as the time from the start of any study treatment to the date of death due to any cause. |
Countries
Canada, France, Italy, Spain, United Kingdom, United States
Outcome results
None listed