Informations générales (source: ClinicalTrials.gov)
A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors
Interventional
Phase 1
AbbVie (Voir sur ClinicalTrials)
février 2021
août 2025
05 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 10/04/2025 13:12:11 | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM - Hopital de la Timone /ID# 225779 - 13385 - Marseille CEDEX 05 - Bouches-du-Rhone - France | Contact (sur clinicalTrials) | ||||
| Centre Georges François Leclerc /ID# 226760 - 21079 - Dijon - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonie /ID# 225778 - 33000 - Bordeaux - Gironde - France | Contact (sur clinicalTrials) | ||||
| Institut Claudius Regaud /ID# 225780 - 31052 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Histologic solid tumor diagnosis (Part 1).
- For Part 2 docetaxel combination therapy: EGFR WT expressing relapsed/refractory
(R/R) non-small cell lung cancer (NSCLC) participants.
- For Part 3 osimertinib combination therapy: mutEGFR-expressing RR NSCLC
participants.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- For Part 1 only - history of R/R disease that has progressed on all standard of care
therapy.
- For Part 2 only - history of RR NSCLC that has progressed after treatment with
platinum-based chemotherapy regimen and either immune checkpoint inhibitor or
targeted therapy and may not have been treated with prior single agent chemotherapy.
- For Part 3 only - history of RR NSCLC that has progressed on osimertinib
- Meet the laboratory values as described in the protocol.
- Histologic solid tumor diagnosis (Part 1).
- For Part 2 docetaxel combination therapy: EGFR WT expressing relapsed/refractory
(R/R) non-small cell lung cancer (NSCLC) participants.
- For Part 3 osimertinib combination therapy: mutEGFR-expressing RR NSCLC
participants.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- For Part 1 only - history of R/R disease that has progressed on all standard of care
therapy.
- For Part 2 only - history of RR NSCLC that has progressed after treatment with
platinum-based chemotherapy regimen and either immune checkpoint inhibitor or
targeted therapy and may not have been treated with prior single agent chemotherapy.
- For Part 3 only - history of RR NSCLC that has progressed on osimertinib
- Meet the laboratory values as described in the protocol.
- History (within 6 months) of congestive heart failure (defined as New York Heart
Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia
requiring pharmacological or surgical intervention, pericardial effusion, or
pericarditis.
- Unresolved Grade 2 or higher toxicities related to previous anticancer therapy
except alopecia.
- For Part 3 only: History of interstitial lung disease (ILD) or pneumonitis that
required treatment with systemic steroids, nor any evidence of active ILD or
pneumonitis.