NCT05914116 · DualityBio Inc.
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
What this study is about
This is a gradually increasing doses and dose-expansion Phase 1/2a trial to evaluate the safety and how well patients handle the treatment of DB-1311/BNT324 in subjects with advanced solid tumors.
View original scientific description
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.
Interventions
DRUG
DB-1311
Administered I.V.(intravenous infusion)
DRUG
Lopinavir and Ritonavir Tablets
Lopinavir and Ritonavir Tablets
DRUG
itraconazole
itraconazole
DRUG
Enzalutamide
oral administration
DRUG
Abiraterone
oral administration
Primary outcome measures
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
Time frame: up to 21 days after Cycle 1 Day 1
Percentage of participants in Part 1 with DLTs
Phase 1& Phase 2a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of participants with TEAEs graded according to National Cancer Institute (NCI) CTCAE v5.0
Phase 1& Phase 2a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Time frame: Up to follow-up period, approximately 1 year post-treatment
Percentage of Participants with SAEs graded according to NCI CTCAE v5.0
Phase 1 & Phase 2a: vital sign measurements
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1& Phase 2a: clinical safety laboratory parameters
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1& Phase 2a: Electrocardiogram (ECG) parameters
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1& Phase 2a: Eastern Cooperative Oncology Group (ECOG) performance status (PS)
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1& Phase 2a: left ventricular ejection fraction (LEVF)
Time frame: Up to follow-up period, approximately 1 year post-treatment
Phase 1: Maximum Tolerated Dose (MTD) of DB-1311/BNT324
Time frame: Up to the completion of Part 1 (assessed up to 12 months)
MTD on the data collected during Part 1
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1311/BNT324
Time frame: Up to the completion of Part 1 (assessed up to 12 months)
RP2D of DB-1311/BNT324 based on the data collected during Part 1
Phase 2a: Objective Response Rate (ORR) as determined by investigator
Time frame: Up to follow-up period, approximately 1 year post-treatment
Objective Response Rate (ORR) as determined by investigator per RECIST 1.1 in non-PC/non-GBM participants per RECIST v1.1 for soft tissue and Prostate Cancer Working Group 3 (PCWG3) criteria for bone metastases in PC participants, and ORR per neuro-oncology 2.0 (RANO 2.0) criteria in GBM participants.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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). 2. 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. 3. 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. 4. Has a life expectancy of ≥ 3 months. 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1. 6. Has LVEF ≥ 50% by either echocardiography (ECHO) or
Where
- Tucson, Arizona
- Los Angeles, California
- Santa Monica, California
- Celebration, Florida
- Margate, Florida
- Orlando, Florida
- Plantation, Florida
- Tamarac, Florida
- Atlanta, Georgia
- Louisville, Kentucky
- Detroit, Michigan
- Saint Paul, Minnesota
And 12 more locations — see the full list below.
Collaborators
BioNTech SE
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 21, 2025 · Source of record for eligibility and locations