Informations générales (source: ClinicalTrials.gov)
A Phase 1 Study With ABBV-CLS-484 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors
Interventional
Phase 1
AbbVie (Voir sur ClinicalTrials)
mars 2021
octobre 2026
05 avril 2025
The study will assess the safety, PK, PD, and preliminary efficacy of ABBVCLS-484 as
monotherapy and in combination with a PD-1 targeting agent or with a or a vascular
endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI).
The trial aims to establish a safe, tolerable, and efficacious dose of ABBVCLS-484 as
monotherapy and in combination. The study will be conducted in three parts. Part 1
Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion
(Monotherapy and Combination therapy).
Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible
subjects who have advanced solid tumors.
Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a
PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid
tumors.
Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined
recommended dose in subjects with locally advanced or metastatic, relapsed or refractory
head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung
cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will
also be administered at the determined recommended dose in combination with a PD-1
targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic,
HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | Jaafar BENNOUNA | 05/05/2025 07:12:09 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Antoine-Lacassagne /ID# 252606 - 06189 - Nice - Provence-Alpes-Cote-d Azur - France | Contact (sur clinicalTrials) | ||||
| Institut Paoli-Calmettes /ID# 260956 - 13009 - Marseille - Bouches-du-Rhone - France | Contact (sur clinicalTrials) | ||||
| IUCT Oncopole /ID# 252673 - 31059 - Toulouse Cedex 9 - Occitanie - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Must weigh at least 35 kilograms (kg).
- An Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
- Life expectancy of >= 12 weeks.
- Laboratory values meeting protocol criteria.
- QT interval corrected for heart rate < 470 msec (using Fridericia's correction), and
no clinically significant electrocardiographic findings.
- Measurable disease defined by RECIST 1.1 criteria.
For Monotherapy and Combination Dose Escalation:
- Participants with histologically or cytologically proven metastatic or locally
advanced tumors, for which no effective standard therapy exists, or where standard
therapy has failed. Participants must have received at least 1 prior systemic
anticancer therapy for the indication being considered.
For Monotherapy Dose Expansion only:
- Participants must have received at least 1 prior line containing PD-1/PD-L1 targeted
therapy with a best response by RECIST v1.1 of CR/PR/stable (any duration) or stable
disease (for greater than 6 months); AND
- Must have been previously treated with 1 or more prior lines of therapy in the
locally advanced or metastatic setting with the following tumor types:
- Relapsed/refractory HNSCC
- Relapsed/refractory NSCLC
- Advanced ccRCC
For PD-1 Targeting Agent Combination Dose Expansion only:
- For the following tumor types, subject must have received at least 1 prior line
containing PD-1/PD-L1 targeted therapy with response by RECIST v1.1 of CR/PR (any
duration) or stable disease (for greater than 6 months):
- Relapsed HNSCC
- Relapsed NSCLC
- Relapsed Advanced ccRCC
- For the following tumor types, subject must have received at least 1 prior line
containing PD-1/PD-L1 targeted therapy and have had disease progression with
PD-1/PD-L1 targeted therapy:
- Locally Advanced or metastatic MSI-H tumors
For VEGFR TKI Combination Dose Expansion only:
- Relapsed advance ccRCC with no more than 1 prior VEGFR TKI
- Participants no recent history of hemorrhage, including hemoptysis, hematemesis, or
melena
- Participants with poorly controlled hypertension are excluded.
- Must weigh at least 35 kilograms (kg).
- An Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
- Life expectancy of >= 12 weeks.
- Laboratory values meeting protocol criteria.
- QT interval corrected for heart rate < 470 msec (using Fridericia's correction), and
no clinically significant electrocardiographic findings.
- Measurable disease defined by RECIST 1.1 criteria.
For Monotherapy and Combination Dose Escalation:
- Participants with histologically or cytologically proven metastatic or locally
advanced tumors, for which no effective standard therapy exists, or where standard
therapy has failed. Participants must have received at least 1 prior systemic
anticancer therapy for the indication being considered.
For Monotherapy Dose Expansion only:
- Participants must have received at least 1 prior line containing PD-1/PD-L1 targeted
therapy with a best response by RECIST v1.1 of CR/PR/stable (any duration) or stable
disease (for greater than 6 months); AND
- Must have been previously treated with 1 or more prior lines of therapy in the
locally advanced or metastatic setting with the following tumor types:
- Relapsed/refractory HNSCC
- Relapsed/refractory NSCLC
- Advanced ccRCC
For PD-1 Targeting Agent Combination Dose Expansion only:
- For the following tumor types, subject must have received at least 1 prior line
containing PD-1/PD-L1 targeted therapy with response by RECIST v1.1 of CR/PR (any
duration) or stable disease (for greater than 6 months):
- Relapsed HNSCC
- Relapsed NSCLC
- Relapsed Advanced ccRCC
- For the following tumor types, subject must have received at least 1 prior line
containing PD-1/PD-L1 targeted therapy and have had disease progression with
PD-1/PD-L1 targeted therapy:
- Locally Advanced or metastatic MSI-H tumors
For VEGFR TKI Combination Dose Expansion only:
- Relapsed advance ccRCC with no more than 1 prior VEGFR TKI
- Participants no recent history of hemorrhage, including hemoptysis, hematemesis, or
melena
- Participants with poorly controlled hypertension are excluded.
- Untreated brain or meningeal metastases (i.e., subjects with history of metastases
are eligible provided they do not require ongoing steroid treatment and have shown
clinical and radiographic stability for at least 28 days after definitive therapy)
- Unresolved Grade 2 or higher toxicities related to previous anticancer therapy
except alopecia.
- Unresolved Grade 2 or higher peripheral neuropathy.
- History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
infection.
- Recent history (within 6 months) of congestive heart failure (defined as New York
Heart Association, Class 2 or higher), ischemic cardiovascular event, pericarditis,
or clinically significant pericardial effusion or arrythmia.
- Recent history (within 6 months) of Childs-Pugh B or C classification of liver
disease.
- History of clinically significant medical and/or psychiatric conditions or any other
reason that, in the opinion of the investigator, would interfere with the subject's
participation in this study or would make the subject an unsuitable candidate to
receive study drug.
- History of uncontrolled, clinically significant endocrinopathy.
- Known gastrointestinal disorders making absorption of oral medications problematic;
subject must be able to swallow capsules.
- If treated with a PD-1/aPD-L1 targeting or other immune-oncology agents in the past,
excluded if had prior pneumonitis, prior Grade 3 or higher immune mediated toxicity,
hypersensitivity to administered drug or drug related toxicity requiring
discontinuation.
- Active autoimmune disease requiring systemic treatment in past 2-years (exceptions
for endocrinopathies, vitiligo or atopic conditions).
- History of solid organ transplant or allogeneic stem cell transplant.
- History of other malignancy, with the following exceptions:
- No known active disease present within >= 3 years before first dose of study
treatment and felt to be at low recurrence by investigator.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- History of interstitial lung disease or pneumonitis.
- Major surgery <= 28 days prior to first dose of study drug
- Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
per local testing practices.