TITRE |
(EN) A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Subjects With Advanced Solid Tumors |
PROTOCOLE ID |
BEHOLD-1 |
CLINICAL TRIAL.gov ID |
NCT06431594 |
TYPE(S) DE CANCER |
Endomètre |
PHASE |
Phase I |
TYPE D'ÉTUDE |
Clinique |
INSTITUTION |
CHUM
1051 rue Sanguinet
(514) 890-8000
|
VILLE |
Montréal
|
INVESTIGATEUR(RICE) PRINCIPAL(E) |
Diane Provencher
|
COORDONATEUR(RICE) |
Adeline Hamon parc.eligibilite.chum@ssss.gouv.qc.ca 514-890-8000 poste 30737
|
STATUT |
Actif en recrutement
|
CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- Males or females aged 18 years or older (≥18 years).
- Participants with pathologically confirmed advanced solid tumor (who have failed or are intolerant to standard of care).
- Participants have at least one target lesion as assessed per the RECIST 1.1
- Tumor tissue from a newly obtained biopsy or archival tumor tissue is required for retrospective detection of B7 homolog 4 (B7-H4) expression by Immunohistochemistry (IHC) in central laboratory and other biomarker analysis. Tissue from a newly obtained biopsy is preferred. If a newly obtained biopsy is not feasible, archival tumor tissue within 2 years prior to the first dose of study drug is acceptable.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 and no deterioration within 2 weeks before the first dose.
- Have a life expectancy of at least 12 weeks.
PROC cohort
- Histologically documented, advanced (metastatic and/or unresectable) high-grade serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
- Must have received or are intolerant to 1 but no more than 3 lines of prior systemic therapy.
- Platinum-resistant disease, defined as progression or relapse within 6 months after the completion of platinum-based therapy.
- Must have had prior bevacizumab if the participant was considered a candidate for this regimen and the regimen is locally available.
- Participants with known Folate receptor-α (FR-α) expressing tumors must have received mirvetuximab soravtasine if the participants was considered a candidate for this regimen and the regimen is locally available.
- Participants with known Breast cancer susceptibility gene (BRCA) mutated tumors should have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor if the participant was considered a candidate for this regimen and the regimen is locally available.
- Maintenance therapy will be considered part of the preceding line of therapy (ie, not counted independently).
Endometrial cancer cohort
- Histologically documented, advanced (metastatic and/or unresectable) or recurrent endometrial cancer.
- Must have received or are intolerant to 1 but no more than 2 lines of prior systemic therapy.
- Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or in separate regimens), if considered a candidate for this regimen and the regimen is locally available.
- Maintenance therapy will be considered part of the preceding line of therapy (ie, not counted independently
- All epithelial histologies are permitted including carcinosarcoma.
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CRITÈRES D'EXCLUSION |
(EN)
- Have received any of B7-H4-targeted therapies.
- Have received any of cytotoxic chemotherapy drugs, anti-tumor traditional Chinese medicines or other anti-tumor drugs within 28 days prior to the first dose of study drug; or need to continue these drugs during the study.
- Have received locoregional radiation therapy within 2 weeks prior to the first dose of study drug; more than 30% of bone marrow irradiation or wide-field radiation therapy within 4 weeks prior to the first dose of study treatment.
- Presence of pleural/abdominal effusion/ascites requiring clinical intervention; presence of pericardial effusion
- Major surgery within 4 weeks prior to the first dose of study treatment.
- Evidence of brain metastasis unless asymptomatic.
- Has inadequate bone marrow reserve or hepatic/renal functions.
- Mean Fridericia-corrected QT interval (QTcF) > 470 millisecond (msec) on resting ECG.
- Evidence of current clinically significant arrhythmias or ECG abnormalities
- Risk factors of prolonged QTc or arrhythmia events,
- Left ventricular ejection fraction (LVEF) < 50%.
- Have severe, uncontrolled or active cardiovascular disorders, serious or poorly controlled hypertension, clinically significant bleeding symptoms or serious arteriovenous thromboembolic events
- Any evidence of current Interstitial lung disease (ILD) or pneumonitis or a prior history of ILD or pneumonitis requiring high-dose systemic glucocorticoids.
- Have received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor Antibody-drug conjugate (ADCs)
PROC
- Primary platinum refractory not permitted.
- Non-epithelial carcinoma, clear-cell, mucinous, germ-cell, low-grade serous, or low-grade endometrioid carcinoma not permitted.
Endometrial cancer
- a Mesenchymal tumors of the uterus (uterine sarcomas) not permitted.
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