Informations générales (source: ClinicalTrials.gov)
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of Mocertatug Rezetecan for Injection in Subjects With Advanced Solid Tumors
Interventional
Phase 1
GlaxoSmithKline (Voir sur ClinicalTrials)
juillet 2024
décembre 2029
28 juin 2026
The goal of this study is to assess the safety and tolerability of Mocertatug Rezetecan .
The study will also see how the levels of Mo-Rez change over time at different dose
amount
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alexandra LEARY | 12/06/2026 08:00:07 | Contacter | ||
Critères
Tous
- 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.
- PROC cohort
1. Histologically documented, advanced (metastatic and/or unresectable) high-grade
serous/endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
2. Must have received or are intolerant to 1 but no more than 4 lines of prior
systemic therapy.
3. Platinum-resistant disease, defined as progression or relapse within 6 months
after the completion of platinum-based therapy.
4. Must have had prior bevacizumab , unless there is a documented contraindication
or intolerance.
5. Participants with known Folate receptor-α (FR-α) expressing tumors must have
received mirvetuximab soravtansine if the regimen is locally available, unless
there is a documented contraindication or intolerance.
Participants with known Breast cancer susceptibility gene (BRCA) mutated tumors should
have received a Poly adenosine diphosphate-ribose polymerase (PARP) inhibitor if the
regimen is locally available, unless there is a documented contraindication or
intolerance.
- Endometrial cancer cohort
1. Histologically documented, advanced (metastatic and/or unresectable) or
recurrent endometrial cancer.
2. Must have received or are intolerant to 1 but no more than 4 lines of prior
systemic therapy.
3. Must have had prior platinum and PD(L)-1 inhibitor (in same regimen or in
separate regimens), if the regimen is locally available, unless there is a
documented contradiction or intolerance
4. All epithelial histologies are permitted including carcinosarcoma.
- 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 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.
Exclusion Criteria:
- Have received any B7-H4-targeted therapy
- 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 28 days 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) QTcF >450 msec or QTcF >480 msec for
participants with bundle branch blocK;
- Evidence of current clinically significant arrhythmias or ECG abnormalities
- 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
- Has current active pneumonitis/ILD or any history of ILD, any history of pneumonitis
requiring steroids or immunomodulatory treatment within 90 days of planned
randomization/enrollment or any history of drug-induced pneumonitis/ILD.Have
received prior therapy with topoisomerase inhibitors or topoisomerase inhibitor
Antibody-drug conjugate (ADCs)
- PROC
1. Primary platinum refractory disease defined as those who have progressed on or
within 12 weeks of last dose of first line platinum therapy not permitted.
2. 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.