protocolSection identificationModule nctId: NCT06274437, orgStudyIdInfo id: BND-35-001, briefTitle: A Study of BND-35 in Participants With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-09, completionDateStruct date: 2027-11, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Biond Biologics, class: INDUSTRY, descriptionModule 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., conditionsModule conditions: Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 280, type: ESTIMATED, armsInterventionsModule interventions name: BND-35, interventions name: Nivolumab, interventions name: Cetuximab, outcomesModule primaryOutcomes measure: Part 1: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), primaryOutcomes measure: Part 1: Proportion of patients who discontinued study treatment due to TEAEs, primaryOutcomes measure: Part 1: Incidence of TEAEs dose limiting toxicities (DLT), primaryOutcomes measure: Part 2: Objective Response Rate (ORR) per RECIST v1.1, primaryOutcomes measure: Part 2: Incidence of TEAEs and SAEs, secondaryOutcomes measure: Part 1: Objective Response Rate (ORR) per RECIST v1.1, secondaryOutcomes measure: Part 1: Maximum observed plasma concentration (Cmax), secondaryOutcomes measure: Part 1: Serum concentration at the end of the dosing interval (Ctrough), secondaryOutcomes measure: Part 1: Time of maximum observed serum concentration (Tmax), secondaryOutcomes measure: Part 1: Terminal elimination half-life (T1/2), secondaryOutcomes measure: Part 1: Area under the plasma concentration-time curve (AUC), secondaryOutcomes measure: Part 1: Incidence of anti-drug antibodies (ADA), secondaryOutcomes measure: Part 2: Progression Free Survival (PFS), secondaryOutcomes measure: Part 2: PFS rate, secondaryOutcomes measure: Part 2: Duration of Response, secondaryOutcomes measure: Part 2: Maximum observed plasma concentration (Cmax), secondaryOutcomes measure: Part 2: Serum concentration at the end of the dosing interval (Ctrough), secondaryOutcomes measure: Part 2: Time of maximum observed serum concentration (Tmax), secondaryOutcomes measure: Part 2: Terminal elimination half-life (T1/2), secondaryOutcomes measure: Part 2: Area under the plasma concentration-time curve (AUC), secondaryOutcomes measure: Part 2: Incidence of anti-drug antibodies (ADA), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Rambam Health Care Campus, city: Haifa, zip: 3109601, country: Israel, contacts name: Ruth Perets, role: CONTACT, contacts role: CONTACT, phone: +97247776234, email: ru_perets@rambam.health.gov.il, geoPoint lat: 32.81841, lon: 34.9885, locations facility: Hadassah University Medical Center, city: Jerusalem, zip: 91120, country: Israel, contacts name: Jonathan Cohen, role: CONTACT, contacts role: CONTACT, phone: +97226776781, email: cohenjon@hadassah.org.il, geoPoint lat: 31.76904, lon: 35.21633, locations facility: Rabin Medical Center, city: Petah Tikva, zip: 49100, country: Israel, contacts name: Solomon Shtemer, role: CONTACT, contacts role: CONTACT, phone: +97239378110, email: shtemers@clalit.org.il, geoPoint lat: 32.08707, lon: 34.88747, locations facility: Sheba Medical Center, city: Ramat Gan, zip: 52621, country: Israel, contacts name: Gal Strauss, role: CONTACT, phone: +97235304498, email: gal.strauss@sheba.health.gov.il, geoPoint lat: 32.08227, lon: 34.81065, locations facility: Tel Aviv Sourasky Medical Center, city: Tel Aviv, zip: 6423906, country: Israel, contacts name: Ravit Geva, role: CONTACT, phone: +97236973193, email: ravitg@tlvmc.gov.il, geoPoint lat: 32.08088, lon: 34.78057, hasResults: False