| Titre |
A Phase 1/2 Open-label, First-in-human, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR444200-based Regimen in Participants With Advanced Solid Tumors. |
| Protocole ID |
TCD17240 |
| ClinicalTrials.gov ID |
NCT05450562 |
| Type(s) de cancer |
Tumeurs solides |
| Phase |
Phase I-II |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Clinique |
| Médicament |
SAR444200 en monothérapie ou avec cémiplimab |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 L'HOTEL-DIEU DE QUEBEC ET CRCEO
11 Côte du Palais, Québec, QC, G1R 2J6
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dr Maxime Chénard-Poirier
|
| Coordonnateur(trice) |
Marie-Pierre Brochu
418-525-4444 poste 15768
|
| Statut |
 Actif en recrutement |
| Date d'activation |
06-07-2022 |
| Critètes d'éligibilité |
-
Cancer diagnosis for participants for Part 1A and Part 1B:
- Metastatic and/or unresectable HCC diagnosed by histology and/or cytology, or diagnosed clinically by the American Association for the Study of Liver Diseases (AASLD) criteria for participants with liver cirrhosis (participants without liver cirrhosis must be diagnosed histologically) OR Other histology/cytology proven advanced and/or metastatic non-HCC solid tumors
- Not amenable to available standard of care: participants must have experienced disease progression on/after standard of care, or no acceptable standard curative or palliative treatments exist (or are no longer effective), according to Investigator judgement, or the patient declines standard of care therapy.
- Cancer diagnosis for participants for Part 2A: Metastatic NSCLC diagnosed by histology and/or cytology not amenable to available standard of care
- Additional for Part 2A: At least 1 measurable lesion per RECIST 1.1 criteria
-
For all participants:
- Positive GPC3 expression on tumor tissue as determined locally or centrally
- Capable of giving signed informed consent
|
| Critètes d'exclusion |
- Eastern Cooperative Oncology Group (ECOG) performance status of ≥2.
- Predicted life expectancy ≤3 months.
- For participants with HCC: Child Pugh Class B or C liver score within 14 days of initiation of IMP. Participants with Child Pugh Class B-7 score are allowed for Part 1A.
- Known active brain metastases or leptomeningeal metastases.
- History of allogenic or solid organ transplant
- Treatment-related immune-mediated (or immune-related) AEs from immune-modulatory agents (including but not limited to anti-PD1/PD-L1 agents and anti-cytotoxic T lymphocyte associated protein 4 monoclonal antibodies) that caused permanent discontinuation of the agent, or that were Grade 4 in severity
- Significant cardiovascular disease within 3 months prior to initiation of IMP, uncontrolled arrhythmia requiring medication, or unstable angina.
- Ongoing AEs caused by any prior anti-cancer therapy >Grade 2
- Known uncontrolled human immunodeficiency virus (HIV), hepatitis B infection, or known untreated current hepatitis C infection
- Known second malignancy either progressing or requiring active treatment within the last year.
- For combination therapy: Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events
- Receipt of a live-virus vaccination within 28 days of planned treatment start.
- For Part 2A, has received prior GPC3 targeted anticancer treatment.
- Current pneumonitis or interstitial lung disease, or history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management.
NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
|
Groupe d'étude en oncologie du Québec