* 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.
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
SGN-STNV
SGN-STNV monotherapy
Donnée non disponible
Inconnu
SGN-STNV
État du recrutement
unknown
SGN-STNV monotherapy
Données à jour depuis :
6 février 2025
Description de l'étude
Description de l'étude
Résumé de l'étude
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.
Source : Importé depuis le centre
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.
Source : Importé depuis le centre
Centres participants
Sites
Centres participants
10
affichés
sur
18
centres
BETH ISRAEL DEACONESS MEDICAL CENTER
Boston
MASSACHUSETTS, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
DANA FARBER CANCER INSTITUTE
Boston
MASSACHUSETTS, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
HOSPITAL UNIVERSITARI VALL D'HEBRON
Barcelona
OTHER, SPAIN
Recrutement local
État du recrutement:
FERMÉ
INSTITUT GUSTAVE ROUSSY
Villejuif cedex
OTHER, FRANCE
Recrutement local
État du recrutement:
FERMÉ
ISTITUTO EUROPEO DI ONCOLOGIA
Milano
LOMBARDIA, ITALY
Recrutement local
État du recrutement:
FERMÉ
MAGEE WOMENS HOSPITAL OF UPMC
Pittsburgh
PENNSYLVANIA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
MEMORIAL SLOAN KETTERING CANCER CENTER
New york
NEW YORK, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
OREGON HEALTH AND SCIENCE UNIVERSITY
Beaverton
OREGON, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
SHANDS CANCER CENTER / UNIVERSITY OF FLORIDA
Gainesville
FLORIDA, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
SOUTH TEXAS ACCELERATED RESEARCH THERAPEUTICS (START)
San antonio
TEXAS, UNITED STATES
Recrutement local
État du recrutement:
FERMÉ
Centres participants
Source d'information
Dernière modification :
6 février 2025
Données à jour depuis :
7 fév.
Origine des données :
clinicaltrials.gov