nctId: NCT06274437 id: BND-35-001 briefTitle: A Study of BND-35 in Participants With Advanced Solid Tumors overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2027-09 date: 2027-11 date: 2024-02-23 date: 2024-02-23 name: Biond Biologics class: INDUSTRY briefSummary: This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with cetuximab. The study will enroll advanced cancer patients with unresectable or metastatic disease who are refractory to or are not candidates for standard approved therapy. The study will be comprised of two parts - a dose escalation phase (Part 1) and a dose optimization (Part 2). Part 1 is comprised of three sub-parts: BND-35 administered alone (Sub-Part 1A), BND-35 administered in combination with nivolumab (Sub-Part 1B), and BND-35 administered in combination with cetuximab (Sub-Part 1C). Part 2 is composed of two sub-parts: a dose optimization part where up to two doses of BND-35 per indication are administered in combination with nivolumab or with cetuximab. conditions: Cancer studyType: INTERVENTIONAL phases: PHASE1 allocation: NON_RANDOMIZED interventionModel: SEQUENTIAL primaryPurpose: TREATMENT masking: NONE count: 280 type: ESTIMATED name: BND-35 name: Nivolumab name: Cetuximab measure: Part 1: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) measure: Part 1: Proportion of patients who discontinued study treatment due to TEAEs measure: Part 1: Incidence of TEAEs dose limiting toxicities (DLT) measure: Part 2: Objective Response Rate (ORR) per RECIST v1.1 measure: Part 2: Incidence of TEAEs and SAEs measure: Part 1: Objective Response Rate (ORR) per RECIST v1.1 measure: Part 1: Maximum observed plasma concentration (Cmax) measure: Part 1: Serum concentration at the end of the dosing interval (Ctrough) measure: Part 1: Time of maximum observed serum concentration (Tmax) measure: Part 1: Terminal elimination half-life (T1/2) measure: Part 1: Area under the plasma concentration-time curve (AUC) measure: Part 1: Incidence of anti-drug antibodies (ADA) measure: Part 2: Progression Free Survival (PFS) measure: Part 2: PFS rate measure: Part 2: Duration of Response measure: Part 2: Maximum observed plasma concentration (Cmax) measure: Part 2: Serum concentration at the end of the dosing interval (Ctrough) measure: Part 2: Time of maximum observed serum concentration (Tmax) measure: Part 2: Terminal elimination half-life (T1/2) measure: Part 2: Area under the plasma concentration-time curve (AUC) measure: Part 2: Incidence of anti-drug antibodies (ADA) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Rambam Health Care Campus city: Haifa zip: 3109601 country: Israel name: Ruth Perets role: CONTACT role: CONTACT phone: +97247776234 email: ru_perets@rambam.health.gov.il lat: 32.81841 lon: 34.9885 facility: Hadassah University Medical Center city: Jerusalem zip: 91120 country: Israel name: Jonathan Cohen role: CONTACT role: CONTACT phone: +97226776781 email: cohenjon@hadassah.org.il lat: 31.76904 lon: 35.21633 facility: Rabin Medical Center city: Petah Tikva zip: 49100 country: Israel name: Solomon Shtemer role: CONTACT role: CONTACT phone: +97239378110 email: shtemers@clalit.org.il lat: 32.08707 lon: 34.88747 facility: Sheba Medical Center city: Ramat Gan zip: 52621 country: Israel name: Gal Strauss role: CONTACT phone: +97235304498 email: gal.strauss@sheba.health.gov.il lat: 32.08227 lon: 34.81065 facility: Tel Aviv Sourasky Medical Center city: Tel Aviv zip: 6423906 country: Israel name: Ravit Geva role: CONTACT phone: +97236973193 email: ravitg@tlvmc.gov.il lat: 32.08088 lon: 34.78057 hasResults: False