Informations générales (source: ClinicalTrials.gov)
A Phase 1, Multi-center, Open Label First-in-Human Study With ABBV-CLS-579 Alone and in Combination in Subjects With Locally Advanced or Metastatic Tumors
Interventional
Phase 1
AbbVie (Voir sur ClinicalTrials)
juin 2020
mai 2026
25 septembre 2024
The purpose of this study is to see how safe and effective ABBV-CLS-579 is when used
alone and in combination with a PD-1 target agent or with a VEGF TKI.
ABBV-CLS-579 is an investigational drug being developed for the treatment of tumors.
The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-579 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 Combination
Dose Expansion.
Part 1, ABBV-CLS-579 will be administered alone in escalating dose levels to eligible
subjects who have advanced solid tumors.
Part 2, ABBV-CLS-579 will be administered at escalating dose levels in combination with a
PD-1 targeting agent to eligible subjects who have advanced solid tumors.
Part 3, ABBV-CLS-579 will be administered at the determined recommended dose in
combination with a PD-1 target agent or with a VEGFR TKI 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).
Adult participants with a diagnosis of some solid tumors for which no effective standard
therapy exists or has failed will be enrolled. Participants will receive study treatment
until disease progresses or discontinued.
There may be a higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the course of the study
at a hospital or clinic. The effect of the treatment will be checked by medical
assessments, blood tests, checking for side effects, and completing questionnaires.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Rastilav BAHLEDA | 17/05/2024 14:01:17 | 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 | |||||
| Hopital Saint-Andre - 33000 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Must weigh at least 35 kilograms (kg).
- For Monotherapy and Combination Dose Escalation:
- Histologically or cytologically proven metastatic or locally advanced tumors
(with measurable disease defined by Response Evaluation Criteria In Solid
Tumors [RECIST] v1.1), 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 Combination Dose Expansion:
- For the following tumor types, the subject must have received at least 1 prior
line containing PD-1/PD-L1 target therapy.
Indication with outcome of Prior PD-1/PD-L1 Targeted Therapy and other disease
characteristics:
- NSCLC
- Relapsed: Tumors express PD-L1 (TPS ≥ 1%) as determined by the FDA-approved
Agilent PD-L1 IHC 22C3 pharmDx kit
- Refractory: Tumors express PD-L1 (TPS ≥ 1%) as determined by the FDA-approved
Agilent PD-L1 IHC 22C3 pharmDx kit
- ccRCC
- Relapsed or Refractory: Advanced disease (locally advanced or metastatic)
- MSI-H tumors
- Refractory: Locally advanced or metastatic MSI-H tumors whose tumors are
determined to have a MSI-H status by PCR or NGS tests, or dMMR by IHC tests.
- HNSCC
- Relapsed or Refractory: Tumors express PD-L1 (CPS ≥ 1] as determined by the FDA
approved PD-L1 Agilent IHC 22C3 pharmDx kit
- For Combination Dose Expansion:
- Locally advanced or metastatic, advanced ccRCC who have relapsed after at least
1 prior VEGFR TKI therapy
- Received at least 1 prior line containing PD 1/PD L1 targeted therapy with a best
response by RECIST v1.1 of CR/PR (any duration) or stable disease (for greater than
6 months)
- Received at least 1 prior line containing PD-1/PD-L1 targeted therapy and have had
disease progression (in the absence of best response of CR/PR/stable disease by
RECIST v1.1) with PD 1/PD L1 targeted therapy
- An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy of ≥ 12 weeks.
- Laboratory values meeting protocol criteria.
- If the subject is on anticoagulant therapy, INR must be within therapeutic goal.
- QT interval corrected for heart rate < 450 msec (using Fridericia's correction), and
no clinically significant electrocardiographic findings.
- Must weigh at least 35 kilograms (kg).
- For Monotherapy and Combination Dose Escalation:
- Histologically or cytologically proven metastatic or locally advanced tumors
(with measurable disease defined by Response Evaluation Criteria In Solid
Tumors [RECIST] v1.1), 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 Combination Dose Expansion:
- For the following tumor types, the subject must have received at least 1 prior
line containing PD-1/PD-L1 target therapy.
Indication with outcome of Prior PD-1/PD-L1 Targeted Therapy and other disease
characteristics:
- NSCLC
- Relapsed: Tumors express PD-L1 (TPS ≥ 1%) as determined by the FDA-approved
Agilent PD-L1 IHC 22C3 pharmDx kit
- Refractory: Tumors express PD-L1 (TPS ≥ 1%) as determined by the FDA-approved
Agilent PD-L1 IHC 22C3 pharmDx kit
- ccRCC
- Relapsed or Refractory: Advanced disease (locally advanced or metastatic)
- MSI-H tumors
- Refractory: Locally advanced or metastatic MSI-H tumors whose tumors are
determined to have a MSI-H status by PCR or NGS tests, or dMMR by IHC tests.
- HNSCC
- Relapsed or Refractory: Tumors express PD-L1 (CPS ≥ 1] as determined by the FDA
approved PD-L1 Agilent IHC 22C3 pharmDx kit
- For Combination Dose Expansion:
- Locally advanced or metastatic, advanced ccRCC who have relapsed after at least
1 prior VEGFR TKI therapy
- Received at least 1 prior line containing PD 1/PD L1 targeted therapy with a best
response by RECIST v1.1 of CR/PR (any duration) or stable disease (for greater than
6 months)
- Received at least 1 prior line containing PD-1/PD-L1 targeted therapy and have had
disease progression (in the absence of best response of CR/PR/stable disease by
RECIST v1.1) with PD 1/PD L1 targeted therapy
- An Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Life expectancy of ≥ 12 weeks.
- Laboratory values meeting protocol criteria.
- If the subject is on anticoagulant therapy, INR must be within therapeutic goal.
- QT interval corrected for heart rate < 450 msec (using Fridericia's correction), and
no clinically significant electrocardiographic findings.
- Untreated brain or meningeal metastases (participants with history of metastases are
eligible provide 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.
- 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, cardiac arrythmia or peripheral
artery disease.
- 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 participation
in this study or would make the participant an unsuitable candidate to receive study
drug.
- History of uncontrolled, clinically significant endocrinopathy.
- Known gastrointestinal disorders making absorption of oral medications problematic.
Inability to swallow capsules.
- If treated with anti-programmed cell death protein-1 (aPD-1)/antiprogrammed cell
death protein-ligand 1(aPD-L1) targeting or other immunostimulatory 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 interstitial lung disease or pneumonitis.
- Major surgery ≤ 28 days prior to first dose of study drug.
- Poorly controlled hypertension
- History of hemorrhage, including hemoptysis, hematemesis, or melena
- History of other malignancy, with the following exceptions:
- No known active disease present for 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
- Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
per local testing practices.