Connexion
M'inscrire

Votre recherche

Filtres

Project précédent
Projet suivant

SGNSTNV-001

A study of sgn-stnv in advanced solid tumors
Source : Importé depuis le centre

Référence clinicaltrials.gov: NCT04665921
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
Source : Importé depuis le centre
Recrutement fermé
Dernière modification : 2025/02/06
Type de recherche

Interventionnel

Médicament expérimental

PHASE1


Population cible

Condition médicale (spécialité visée)

Donnée non disponible

Profil des participants

Sexe(s) des participants

ALL

Source : Importé depuis le centre

Critères de sélection

Critères d'inclusion

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.

Source : Importé depuis le centre

Thérapie ou Intervention proposée

Cohortes
SGN-STNV
État du recrutement
unknown
Données à jour depuis : 6 février 2025

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

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

Dernière modification : 6 février 2025
Données à jour depuis : 7 fév.
Origine des données : clinicaltrials.gov
Référence clinicaltrials.gov: NCT04665921