Clinical Trials Logo

Clinical Trial Summary

The aim of this study is to investigate the safety and the clinical activities of NP137 when combined with pembrolizumab and/or chemotherapies in patients with advanced/metastatic gynecological cancers (2 types: endometrial carcinoma and cervix carcinoma).


Clinical Trial Description

The prognosis of patients with locally advanced/metastatic uterine (endometrial or cervical) cancer progressing/relapsing after at least one prior systemic treatment remains poor. The development of new innovative anti-tumor drug candidates as single agent or in combination with chemotherapy or check point inhibitors is needed. NP137 is a first-in-class humanized monoclonal antibody targeting specifically and selectively Netrin-1. By blocking Netrin-1, NP137 is capable of restoring apoptosis in tumor cells in vitro and in vivo, leading to therapeutic activity in various animal cancer models. Dependence receptors inhibitor such as NP137 might be a novel choice to improve the clinical outcomes of these patients. The herein proposed study will be a multicenter, open-label, randomized, Phase I/II trial with: A safety run in part to assess the safety of the therapeutic combinations for the first 6 patients enrolled in each of the therapeutic combinations independently of the tumor type. According to safety rules, these therapeutic combinations will be investigated or not in the Phase II part. A Phase II part will be then conducted using an adaptive Bayesian approach allowing to quickly stop treatment cohorts without evidence of efficacy and/or select promising treatment cohorts. The Phase II part will be initiated with a preliminary step to assess the clinical activity of the proposed therapeutic combinations in 2 tumor types before proceeding to the activation of extension phase II part of the study. For each cohorts, clinical activity will be assessed through by sequential statistical analysis at specific timepoints. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04652076
Study type Interventional
Source NETRIS Pharma
Contact Ray-Coquard Isabelle, MD, PhD
Phone +33(0)4 78 78 28 28
Email isabelle.ray-coquard@lyon.unicancer.fr
Status Recruiting
Phase Phase 1/Phase 2
Start date December 14, 2020
Completion date July 30, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Recruiting NCT05036681 - A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma Phase 2
Completed NCT00729586 - Temsirolimus With or Without Megestrol Acetate and Tamoxifen Citrate in Treating Patients With Advanced, Persistent, or Recurrent Endometrial Cancer Phase 2
Completed NCT00756847 - Safety Study of XL147 (SAR245408), in Combination With Paclitaxel and Carboplatin in Adults With Solid Tumors Phase 1
Completed NCT02983279 - Caloric Restriction Before Surgery in Treating Patients With Endometrial, Prostate, or Breast Cancer N/A
Completed NCT02017353 - Effect of Curcumin Addition to Standard Treatment on Tumour-induced Inflammation in Endometrial Carcinoma Phase 2
Completed NCT00997373 - Letrozole as a Treatment of Endometrial Cancer N/A
Recruiting NCT04851119 - Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors Phase 1/Phase 2
Recruiting NCT04576104 - Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer Phase 2
Not yet recruiting NCT06102252 - Combination Chemotherapy of Paclitaxel and Carboplatin With or Without Anthracycline as an Adjuvant Treatment in Endometrial Carcinoma N/A
Active, not recruiting NCT02598219 - Evaluation of Sentinel Node Policy in Early Stage Endometrial Carcinomas at Intermediate and High Risk of Recurrence. Phase 3
Recruiting NCT04159155 - A Study of Various Treatments in Serous or p53 Abnormal Endometrial Cancer Phase 2/Phase 3
Recruiting NCT05139368 - Hypofractionated Radiotherapy for the Treatment of Cervical or Endometrial Cancer N/A
Recruiting NCT02611024 - Pharmacokinetic Study of Lurbinectedin in Combination With Irinotecan in Patients With Selected Solid Tumors Phase 1/Phase 2
Completed NCT03849469 - A Study of XmAb®22841 Monotherapy & in Combination w/ Pembrolizumab in Subjects w/ Selected Advanced Solid Tumors Phase 1
Suspended NCT06253494 - Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer Phase 1/Phase 2
Active, not recruiting NCT03917381 - GEN1046 Safety Trial in Patients With Malignant Solid Tumors Phase 1/Phase 2
Completed NCT03372720 - Fractional CO2 Laser Therapy in Minimizing Genitourinary Syndrome of Menopause in Gynecological Cancer Survivors N/A
Recruiting NCT06413992 - Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer Phase 2
Recruiting NCT05316467 - Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma Phase 2/Phase 3