a study of sgn-stnv in advanced solid tumors

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

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.

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.

Eligibility 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.

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