Type : | Industriel |
Statut : | Ouvert |
Phase : | I |
Étape du traitement : | Traitements combinés |
Date d'ouverture : | 23/02/2021 |
Date clôture : | 28/11/2026 |
Promoteur : | AbbVie |
Progression du cancer: | Loco-régional |
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumors (NSCLC). Adverse events and change in disease activity will be assessed.
ABBV-637 is an investigational drug being developed for the treatment of solid tumors. Study consists of 3 parts - monotherapy dose escalation (Part 1), combination dose escalation and expansion (Parts 2a and 2b) with docetaxel and combination dose escalation and expansion (Parts 3a and 3b) with osimertinib. Approximately 109 adult participants with relapsed/refractory (R/R) solid tumors will be enrolled in approximately 30 sites across the world.
In Part 1, participants with solid tumors will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28-day cycle.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. Treatment effects will be monitored by medical assessments, blood tests, side effect reporting, and questionnaires.
- Cancers de la peau
- Mélanome
- Cancers basocellulaires
- Autres cancers de la peau
- Cancers digestifs
- Œsophage
- Estomac
- Colon
- Rectum
- Foie –Voie biliaire
- Pancréas
- Carcinose péritionéale
- Tumeurs neuro-endocrines gastro-intestinales
- Autres cancers digestifs
- Tumeurs neuro-endocrines pancréatiques
- Cancers de la thyroïde et Tumeurs endocrines
- Thyroide
- Corticosurrénalome
- Phéochromocytome
- Tumeurs neuro-endocrines
- Paragangliome
- Autres cancers de la thyroïde
- Cancers gynécologiques
- Ovaire
- Endomètre
- Col de l’utérus
- Trompe de Fallope
- Péritoine
- Autres cancers gynécologiques
- Cancers uro-génitaux
- Rein
- Vessie
- Prostate
- Testicule
- Autres cancers uro-génitaux
- Cancers du système nerveux central
- Médulloblastome
- Gliomes
- Chordome
- Craniopharyngiome
- Lymphome
- Métastase cérébrale
- Méningiome
- Méningite carcinomateuse
- Autres cancers du système nerveux central
- Cancers thoraciques respiratoires
- Cancer bronchique non à petites cellules
- Cancer bronchique à petites cellules
- Mésothéliome
- Tumeur thymiques
- Tumeur médiastinales
- Métastases pulmonaires
- Autre cancers thoraciques respiratoires
- Tumeurs neuro-endocrines pulmonaires
- Cancers des VADS
- Adénopathie(s) cervicale(s) métastatique(s) de primitif inconnu sans métastase à distance
- Carcinome épidermoïde de l'hypopharynx et du larynx
- Carcinome épidermoïde de l'oropharynx
- Carcinome épidermoïde de la cavité buccale
- Carcinome épidermoïde des lèvres
- Carcinomes nasopharyngés
- Tumeurs des glandes salivaires
- Tumeurs malignes nasosinusiennes
- Autre cancers des VADS
- Cancer du sein
- Sarcomes (tissus mous et os)
- Tumeurs stromales gastro-intestinales (GIST)
- Cancer de site primitif inconnu
- Cancer de la tête et du cou