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BP29889: An Open-Label, Multicenter, Dose Escalation Phase Ib Study With Expansion Cohorts to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of RO7009789 (CD40 Agonistic Monoclonal Antibody) in Combination With Vanucizumab (Anti-Ang2 and Anti-VEGF Bi-Specific Monoclonal Antibody, Part I) or Bevacizumab (Anti-VEGF Monoclonal Antibody, Part II) in Patients With Metastatic Solid Tumors

Studio Clinico

Patologia: Neoplasie della mammella, Tumori dell’ovaio, Tumori della testa e del collo, Neoplasie del polmone, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: I, I B

Richiesta mandatoria di tessuto: 

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Patients ≥ 18 years
- Part I: Histologically confirmed advanced/metastatic solid tumor (except prostate cancer and squamous non-small cell lung cancer [NSCLC])
- Part II: Histologically confirmed advanced/metastatic platinum-resistant ovarian carcinoma (aPROC), head and neck squamous cell carcinoma (HNSCC), or non-squamous NSCLC previously treated with anti-PD-L1/PD-1 inhibitor alone or in combination (e.g. atezolizumab, nivolumab, pembrolizumab, durvalumab, avelumab)
- Checkpoint inhibitor (CPI)- experienced patients must have experienced documented disease progression on or after PD-L1/PD-1 inhibitor therapy
- In CPI-experienced patients, the PD-L1/PD-1 inhibitor must have been part of the most recent systemic anticancer therapy administered prior to study enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Life expectancy >/= 16 weeks
- Adequate hematologic, renal, hepatic, and cardiovascular function
- Measurable disease per Response Evaluation Criteria in Solid Tumors, v 1.1 (RECIST v1.1)
- Tumors must be acceptable for biopsy
- Agreement to use adequate contraceptive measures among men or among women of childbearing potential

Criteri di esclusione: 

- Prostate cancer or squamous NSCLC
- Recent systemic anti-cancer treatment
- Prior treatment with anti-programmed death (PD) 1 or anti-programmed death ligand (PD-L) 1 therapeutic antibody, vanucizumab, or compounds targeting cluster of differentiation (CD) 40
- Part II: Treatment targeting vascular endothelial growth factor (VEGF) or receptor within 12 months prior to enrollment
- Systemic immunosuppressive medication within 2 weeks prior to day 1 of cycle 1
- Chronic daily treatment with non-steroidal anti-inflammatory drugs
- Unacceptable/unresolved toxicity from prior anti-cancer therapy
- Patients who have had a surgical procedure or significant traumatic injury within 28 days prior to initiation of study treatment, or a core biopsy or other minor surgical procedure within 7 days prior to initiation of study treatment
- Bisphosphonate therapy for symptomatic hypercalcemia
- Significant vascular disease
- History of hypertensive crisis or hypertensive encephalopathy
- Current or recent use of aspirin (>325 mg/day) or clopidogrel (>75 mg/day)
- History of vein thrombosis/thromboembolism, or use of anticoagulants within 7 days prior to study drug
- Primary tumor in place in participants with colorectal cancer, or evidence of bowel involvement (metastasis, direct tumor invasion) in participants with other non-gastrointestinal cancer
- Significant cardiovascular or cerebrovascular disease within 6 months prior to D1 of C1
- History of bowel obstruction, perforation, or abscess
- Prior radiotherapy to pelvis or abdomen, recto-sigmoid involvement, or bowel involvement among participants with aPROC
- Severe non-healing wound, active ulcer or untreated bone fracture
- Pregnant or lactating women
- History of autoimmune disease
- Human immunodeficiency virus (HIV) or hepatitis B or C
- Severe infection or receipt of a live/attenuated vaccine within 4 weeks prior to D1 of C1
- Other significant malignancies within 3 years prior to D1 of C1
- Allergy/hypersensitivity to study drug
- Prior allogeneic bone marrow or solid organ transplant
- Other conditions/findings that may contraindicate use of study drug
- Major surgery within 4 weeks prior to study drug
- Known clinically significant liver disease
- History of hemoptysis or bleeding diathesis, or known coagulopathies
- Known symptomatic or untreated central nervous system (CNS) malignancy

Trattamento sperimentale: 

Part I (Dose Escalation): Selicrelumab, Vanucizumab
Part II (Expansion): Selicrelumab, Bevacizumab

Trattamento di controllo: 


Obiettivi primari dello studio: 

- Percentage of Participants With Dose-Limiting Toxicities (DLTs) [Time Frame: From Day (D) 1 until D28 of Cycle (C)1]
- MTD of Selicrelumab in Combination With Vanucizumab [Time Frame: From D1 until D28 of C1]
- Recommended Phase II Dose of Selicrelumab in Combination With Vanucizumab [Time Frame: From D1 until D28 of C1]
- Percentage of Participants With Adverse Events (AEs) [Time Frame: From D1 of C1 until treatment discontinuation and approximately 45 days after last dose (up to 9 months in Part I and 15 months in Part II; cycle length=28 days)]
- Clinical Activity of SC Selicrelumab in Combination with Bevacizumab as Assessed by Response Evaluation in Solid Tumors, Version 1.1 (RECIST v1.1) [Time Frame: From D1 of C1 through safety follow up visit (45 days post final dose; Cycle = 28 days)]
- Clinical Activity of SC Selicrelumab in Combination with Bevacizumab as Assessed by Unidimensional Immune-Related Response Criteria (irRC) [Time Frame: From D1 of C1 through safety follow up visit (45 days post final dose; Cycle = 28 days)]

Note generali: 

Arruolamento momentaneamento sospeso

La linea di trattamento dipende dalla coorte e dalla patologia

Centri partecipanti

Nord Italia

Via P. Maroncelli 40 - 47014 Meldola - FC


Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI

Riferimento: Dr. Luca Gianni
Telefono: 0226436529

Informazioni Generali


Numero di iscrizione a registro: 2015-003480-11

Data di inserimento: 07.03.2019


Hoffmann-La Roche



Principal Investigator ITALIA

Ospedale San Raffaele IRCCS, Milano

Riferimento: Dr. Luca Gianni

Telefono: 0226436529


Localita: Milano


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