A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDualityBio Inc.
About this trial
This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female adults (defined as ≥ 18 years of age or acceptable age according to local regulations at the time of voluntarily signing of informed consent).
Histologically or cytologically confirmed unresectable advanced/metastatic solid tumor that has relapsed or progressed on or after standard systemic treatments, or is intolerable with standard treatment; or for which no standard treatment is available.
At least one measurable lesion as assessed by the investigator according to response evaluation criteria in solid tumors (RECIST) version 1.1 criteria (measurable disease as defined by RANO 2.0 criteria for GBM subjects). Castrate-resistant prostate cancer (CRPC) subjects with bone only disease may be eligible on a case-by- case basis after discussion with the Medical Monitor.
Has a life expectancy of ≥ 3 months.
Disqualifiers
Prior treatment with B7-H3 targeted therapy.
Prior treatment with antibody drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan).
Has a medical history of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] classes II-IV) or serious cardiac arrhythmia requiring treatment.
Has a medical history of myocardial infarction or unstable angina within 6 months before enrollment.
Trial design
Design model
Sequential
Treatments tested in this trial
DB-1311
DrugAdministered I.V.(intravenous infusion)
Lopinavir and Ritonavir Tablets
DrugLopinavir and Ritonavir Tablets
itraconazole
Drugitraconazole
Enzalutamide
Drugoral administration
Abiraterone
Drugoral administration
Treatment groups
862 Participants
are divided into 23 treatment groups23
Treatment groupsSee each treatment group below.
Group A: DB-1311/BNT324 Dose Level 1Experimental treatment 1 intervention
Group B: DB-1311/BNT324 Dose Level 2Experimental treatment 1 intervention
Group C: DB-1311/BNT324 Dose Level 3Experimental treatment 1 intervention
Group D: DB-1311/BNT324 Dose Level 4Experimental treatment 1 intervention
Group E: DB-1311/BNT324 Dose Level 5Experimental treatment 1 intervention
Group F: DB-1311/BNT324 Dose Expansion 1Experimental treatment 1 intervention
Group G: DB-1311/BNT324 Dose Expansion 2Experimental treatment 1 intervention
Group H: DB-1311/BNT324 Dose Expansion 3Experimental treatment 1 intervention
Group I: DB-1311/BNT324 Dose Expansion 4Experimental treatment 1 intervention
Group J: DB-1311/BNT324 Dose Expansion 5Experimental treatment 1 intervention
Group K: DB-1311/BNT324 Dose Expansion 6Experimental treatment 1 intervention
Group L: DB-1311/BNT324 Dose Expansion 7Experimental treatment 1 intervention
Group M: DB-1311/BNT324 Dose Expansion 8Experimental treatment 1 intervention
Group N: DB-1311/BNT324 Dose Expansion 9Experimental treatment 1 intervention
Group O: DB-1311/BNT324 Dose Expansion 10Experimental treatment 1 intervention
Group P: DB-1311/BNT324 Dose Expansion 11Experimental treatment 1 intervention
Group Q: DB-1311/BNT324 Dose Expansion 12Experimental treatment 1 intervention
Group R: DB-1311/BNT324 Dose Expansion 13Experimental treatment 1 intervention
Group S: DB-1311/BNT324 Dose Expansion 14Experimental treatment 1 intervention
Group T: DB-1311/BNT324 Dose Expansion 15Experimental treatment 3 interventions
Group U: DB-1311/BNT324 Dose Expansion 16Experimental treatment 2 interventions
Group V: DB-1311/BNT324 Dose Expansion 17Experimental treatment 2 interventions
Group W: DB-1311/BNT324 Dose Expansion 18Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Phase 1: Percentage of Participants with Dose-Limiting Toxicities (DLTs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Percentage of participants in Part 1 with DLTs
Percentage of participants in Part 1 with DLTs
Time frame
up to 21 days after Cycle 1 Day 12
Phase 1& Phase 2a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Percentage of participants with TEAEs graded according to National Cancer Institute (NCI) CTCAE v5.0
Time frame
Up to follow-up period, approximately 1 year post-treatment3
Phase 1& Phase 2a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Percentage of Participants with SAEs graded according to NCI CTCAE v5.0
Time frame
Up to follow-up period, approximately 1 year post-treatment4
Phase 1 & Phase 2a: vital sign measurements
Time frame
Up to follow-up period, approximately 1 year post-treatmentSecondary outcomes
1
Phase 1: Objective response rate (ORR)
ORR will be determined by investigator per RECIST v1.1 in non-CRPC participants, and per RECIST v1.1 for soft tissue and PCWG3 criteria for bone metastases in CRPC participants
Time frame
Up to follow-up period, approximately 1 year post-treatment2
Phase 1 & Phase 2a: duration of response (DoR)
DoR will be determined by investigator per RECIST v1.1 in non-PC/non-GBM participants, per RECIST v1.1 for soft tissue and PCWG3 criteria for bone metastases in PC participants, and per RANO 2.0 criteria in GBM participants
Time frame
Up to follow-up period, approximately 1 year post-treatment3
Phase 1 & Phase 2a: disease-control rate (DCR)
DCR will be determined by investigator per RECIST v1.1 in non-PC/non-GBM participants, per RECIST v1.1 for soft tissue and PCWG3 criteria for bone metastases in PC participants, and per RANO 2.0 criteria in GBM participants
Time frame
Up to follow-up period, approximately 1 year post-treatment4
Phase 1 & Phase 2a: Time to Response (TTR)
TTR will be determined by investigator per RECIST v1.1 in non-PC/non-GBM participants, per RECIST v1.1 for soft tissue and PCWG3 criteria for bone metastases in PC participants, and per RANO 2.0 criteria in GBM participants
Time frame
Up to follow-up period, approximately 1 year post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
DualityBio Inc.
Lead sponsor
BioNTech SE
Collaborator
Source ClinicalTrials.gov