A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors (NCT05914116) | Clinical Trial Compass
RecruitingPhase 1/2
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
United States, Australia, China862 participantsStarted 2023-08-17
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
. 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.
. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
. Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment.
. Has adequate organ function within 7 days prior to Day 1 of Cycle 1
. Has adequate treatment washout period prior to Day 1 of Cycle 1
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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
Timeframe: up to 21 days after Cycle 1 Day 1
2
Phase 1& Phase 2a: Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) as assessed by CTCAE v5.0.
Timeframe: Up to follow-up period, approximately 1 year post-treatment
3
Phase 1& Phase 2a: Percentage of Participants with Serious Adverse Events (SAEs) as assessed by CTCAE v5.0.
Timeframe: Up to follow-up period, approximately 1 year post-treatment
4
Phase 1 & Phase 2a: vital sign measurements
Timeframe: Up to follow-up period, approximately 1 year post-treatment
. 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.
. Has an average of Fredericia's formula-QT corrected interval (QTcF) prolongation to \> 470 millisecond (ms) in males and females based on a 12-lead electrocardiogram (ECG) in triplicate.
. Use of concomitant medications known to prolong the QT interval. If the use is deemed necessary, they should be administered with caution and closely monitoring the QT interval, after discussed with the Sponsor.
. Has a medical history of interstitial lung diseases (e.g., non-infectious interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung diseases or who are suspected to have these diseases by imaging at screening.
. Has a history of underlying pulmonary disorder including, but not limited to, pulmonary emboli within 3 months of the start of study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.
7
Phase 1& Phase 2a: Eastern Cooperative Oncology Group (ECOG) performance status (PS)
Timeframe: Up to follow-up period, approximately 1 year post-treatment
8
Phase 1& Phase 2a: left ventricular ejection fraction (LEVF)
Timeframe: Up to follow-up period, approximately 1 year post-treatment
9
Phase 1: Maximum Tolerated Dose (MTD) of DB-1311/BNT324
Timeframe: Up to the completion of Part 1 (assessed up to 12 months)
10
Phase 1: Recommended Phase 2 Dose (RP2D) of DB-1311/BNT324
Timeframe: Up to the completion of Part 1 (assessed up to 12 months)
11
Phase 2a: Objective Response Rate (ORR) as determined by investigator
Timeframe: Up to follow-up period, approximately 1 year post-treatment