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Identifiant
GO45416
Titre
Une étude pour évaluer la sécurité, la pharmacocinétique et l'activité de gdc-7035 en tant qu'agent unique et en combinaison chez des patients atteints de tumeurs solides avancées
Source : traduction non-officielle opérée par intelligence artificielle
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a study to evaluate safety, pharmacokinetics, and activity of gdc-7035 as a single agent and in combination in patients with advanced solid tumors
* Tumeur solide avancée ou métastatique documentée histologiquement avec mutation KRAS G12D
* Accord pour adhérer aux exigences de contraception décrites dans le protocole pour les participants en âge de procréer et les participants qui produisent du sperme
Critères d'exclusion :
* Malabsorption ou autre condition qui interférerait avec l'absorption entérale
* Métastases cérébrales actives
* Dysfonction cardiovasculaire ou maladie hépatique cliniquement significative
Source : traduction non-officielle opérée par intelligence artificielle
voir le texte original
Inclusion Criteria:
* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
Exclusion criteria:
* Malabsorption or other condition that would interfere with enteral absorption
* Active brain metastases
* Clinically significant cardiovascular dysfunction or liver disease
Critères d'exclusion
Individuals who meet any of the following criteria will be excluded from study entry:
* Known hypersensitivity or medical contraindication to any component of GDC-7035 formulation
*Inability or unwillingness to swallow pills
*Inability to comply with study and follow-up procedures
*Malabsorption syndrome or other condition that would interfere with enteral absorption
*Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
Participants with a history of treated CNS metastases are eligible, provided they meet all of the following criteria:
-Measurable or evaluable disease outside the CNS
-No history of intracranial hemorrhage or spinal cord hemorrhage
-No ongoing requirement for corticosteroids as therapy for CNS metastases, with corticosteroids discontinued for „d 2 weeks prior to
enrollment and no ongoing symptoms attributed to CNS metastases
-No stereotactic radiation within 7 days or whole-brain radiation within 14 days prior to Cycle 1 Day 1
_ No evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study Note: Participants with new asymptomatic CNS metastases detected at screening are eligible for the study after receiving radiotherapy and/or surgery. Following treatment, these participants may be eligible without the need to repeat the additional brain scan, if all other criteria are met.
*Pregnant or breastfeeding, or intention of becoming pregnant during study treatment and for 2 months after the final dose of GDC-7035 and 2 months after the final dose of panitumumab (see Section 5.4)
*Participants of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.
*Participants with chronic diarrhea, short bowel syndrome or significant upper GI surgery including gastric resection, a history of inflammatory bowel disease (e.g., Crohn¡¦s disease or ulcerative colitis) or any active bowel inflammation (including diverticulitis)
*Treatment with chemotherapy, immunotherapy, biologic therapy, or an investigational agent as anti-cancer therapy within 3 weeks or five half-lives prior to initiation of study treatment, whichever is shorter, or endocrine therapy within 2 weeks prior to initiation of study treatment, except for the following: Hormonal therapy with gonadotropin-releasing hormone (GnRH) agonists or antagonists for endocrine-sensitive cancers (e.g., prostate, endometrial, hormone receptor-positive breast cancer) is allowed. Kinase inhibitors, approved by regulatory authorities, may be used up to 2 weeks prior to initiation of study treatment, provided any drug-related toxicity has completely resolved and upon consultation with the Medical Monitor.
*Radiation therapy (other than palliative radiation to bony metastases and radiation to CNS metastases as described above) as cancer therapy within 4 weeks prior to initiation of study treatment
*Palliative radiation to bony metastases within 2 weeks prior to initiation of study treatment
*Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better except for alopecia, vitiligo, endocrinopathy managed with replacement therapy, or Grade „T 2 peripheral neuropathy
*Treatment with a strong CYP3A inhibitor or strong CYP3A inducer within 14 days or5 drug elimination half-lives, whichever is longer, prior to initiation of study treatment
*Expected need for ongoing treatment with a strong CYP3A inhibitor or strongCYP3A inducer
*Poor peripheral venous access without central access
*Major surgical procedure within 28 days prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
*Participants with biliary obstruction for whom a biliary drain or stent has been placed are eligible, provided that the drain or stent has been in place for at least 10 days prior to initiation of study treatment, and the liver function has stabilized.
*Prophylactic routine immunizations or vaccinations within 2 weeks prior to initiation of study treatment or planned vaccine treatment during the DLT assessment window
*Infection requiring systemic (i.e., oral, IV, or intramuscular) antibiotics within 7 days prior to initiation of study treatment or any evidence of current infection (e.g., bacterial, viral, fungal) In the setting of a pandemic or epidemic, screening for active infections should be considered according to local or institutional guidelines or guidelines of applicable professional societies.
*Any medical condition or abnormal clinical laboratory finding that, in the investigator's judgment, would preclude the individual's safe participation in and completion of the study or could affect the interpretation of the results
*Any prior treatment with RAS targeted small molecule inhibitors (e.g., KRAS G12Cinhibitors, KRAS G12D inhibitors, pan KRAS inhibitors, and pan RAS inhibitors) Prior treatment with inhibitors targeting other components of the MAPK pathway (e.g., MEK or BRAF inhibitors) is permitted.
*History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome (such as appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ,or Stage I uterine cancer)
*Known clinically significant liver disease, including active viral, alcoholic, or other forms of hepatitis, cirrhosis, and inherited liver disease, or current alcohol abuse, or evidence of active or clinically significant biliary disease
*History of or active clinically significant cardiovascular dysfunction,
* QT interval corrected through use of Fridericia's formula (QTcF) Ĩ 450 ms
*Medications that are well known to prolong the QT interval within 14 days or 5 drug elimination half-lives, whichever is longer, prior to initiation of study treatment or anticipated need during study treatment with GDC-7035 and for 30 days after the final dose of GDC-7035
* Any other diseases, metabolic dysfunction, physical examination finding, and/or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications
Source : Importé depuis le centre
Cohortes
Thérapie ou Intervention proposée
Cohortes
Nom
Condition médicale
Traitement
État du recrutement
Phase I Arm A
Branche d'escalade de dose et d'expansion
Donnée non disponible
Inconnu
Phase I Arm B
Branche d'escalade de dose et d'expansion
Donnée non disponible
Inconnu
Phase I Arm A
État du recrutement
inconnu
Branche d'escalade de dose et d'expansion
Phase I Arm B
État du recrutement
inconnu
Branche d'escalade de dose et d'expansion
Données à jour depuis :
28 juin 2025
Description de l'étude
Description de l'étude
Résumé de l'étude
Il s'agit d'une étude de phase I/II, première chez l'homme, ouverte, multicentrique, avec augmentation de dose et expansion conçue pour évaluer la sécurité, la pharmacocinétique et l'activité préliminaire de GDC-7035 en tant qu'agent unique et en combinaison avec d'autres thérapies anticancéreuses chez des participants atteints de tumeurs solides avancées ou métastatiques qui portent la mutation KRAS G12D.
Source : traduction non-officielle opérée par intelligence artificielle
voir le texte original
This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.
Centres participants
Sites
Centres participants
10
affichés
sur
16
centres
CENTRE INTÉGRÉ UNIVERSITAIRE DE SANTÉ ET DE SERVICES SOCIAUX DU CENTRE-OUEST-DE-L’ÎLE-DE-MONTRÉAL
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