Phase 1/2a Study of DB-1311/BNT324 for Advanced Solid Tumors
This study is testing a new drug called DB-1311/BNT324 for people with advanced or metastatic (spread to other parts of the body) solid tumors. You might be able to join if your cancer has progressed after standard treatments or if you can't tolerate those treatments. The main goals are to find a safe dose of DB-1311/BNT324 and to see how well it is tolerated. Researchers will also look at side effects (adverse events) and serious side effects. The study plans to enroll 862 participants. The current recruitment status is unclear.
- Study design
- This is an open-label (you and your doctor will know what treatment you are receiving) Phase 1/2a study. It will involve multiple doses and aims to find the maximum tolerated dose and recommended dose for future studies.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for side effects for up to approximately 1 year after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05914116
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentDualityBio Inc.
~862 participants
Updated 2025-11-21 on ClinicalTrials.gov
What's tested:DB-1311Lopinavir and Ritonavir TabletsitraconazoleEnzalutamideAbiraterone
At a glance
Recruiting sites
107 of 107 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over up to 21 days after Cycle 1 Day 1
+10 more outcomes measured
Conditions
Where it's being run
107 sites across 41 statesTaiwan9
New South Wales8
Guangdong6
Zhejiang6
Florida5
California4
Chongqing Municipality4
Henan4
Study leadership
- Lily Hu · STUDY_DIRECTOR · DualityBio Inc.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Pathologically documented locally advanced, or metastatic SCLC not amenable to curative surgery or radiation.
Prior therapy with at least one platinum-based line as systemic therapy for extensive stage disease with at least two cycles of therapy (except in the case of early objective PD).
Prior treatment regimens with irinotecan, topotecan or any other TOP I inhibitor including investigational TOP I inhibitors are not allowed. 15. NSCLC subjects (Phase 2a Cohort 2 ONLY):
Pathologically documented locally advanced, or metastatic NSCLC and is not amenable to curative surgery or radiation.
Has received prior treatment with platinum-based chemotherapy regimen and/or anti-PD-1/PD-L1 antibody-based regimen in the advanced/unresectable, or metastatic setting unless unable or unwilling. Subjects with NSCLC known to harbor a genomic alteration(s) other than EGFR mutation(s) (e.g., ALK rearrangement, ROS1 rearrangement, KRAS G12C mutation, BRAF V600E mutation, NTRK1/2/3 Gene fusion, MET Exon 14 skipping, RET rearrangement etc.) for which treatment is available must have also received prior treatment with at least 1 genotype-directed therapy. 16. ESCC subjects (Phase 2a Cohort 3 ONLY):
Pathologically documented locally advanced, or metastatic ESCC and is not amenable to curative surgery or radiation.
Having received at least one prior therapy for unresectable disease. Patients with recurrence within 6 months of completion of neoadjuvant or adjuvant therapy will be considered as having received one prior therapy for unresectable disease. 17. CRPC subjects (Phase 2a Cohort 4 ONLY):
Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND 2) progressive disease as defined by PCWG3 criteria.
Having received prior docetaxel (before or after an AR-targeted therapy). Docetaxel rechallenge was allowed.
Having received prior novel hormone therapy. 18. Melanoma subjects (Phase 2a Cohort 5 ONLY) • Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma not amenable to local therapy, must have had either:
Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria (fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC are not eligible), and:
Has received 1 or 2 prior systemic therapy regimens for recurrent or metastatic disease;
Has experienced disease progression during or after treatment with an anti-PD-1/L1 agent administered either as monotherapy or in combination.
Pathologically documented metastatic adenocarcinoma of the prostate cancer. Progressive metastatic CRPC as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND 2) progressive disease as defined by PCWG3 criteria.
Subjects must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous or endometrioid histology..
Subjects must have platinum-resistant disease:
Received at least 1 but ≤ 3 lines of prior systemic anticancer therapy and have radiographic progressed on or after their most recent line of therapy.
Pathologically documented adenocarcinoma of the prostate cancer.
Having advanced/unresectable, or metastatic disease and confirmed by imaging (e.g., CT and/or bone scan).
Having received ADT and enzalutamide or abiraterone for ≥4 months, with suboptimal PSA response.
What this trial 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 DLTsup 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.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.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 measurementsUp to follow-up period, approximately 1 year post-treatment
- Phase 1& Phase 2a: clinical safety laboratory parametersUp to follow-up period, approximately 1 year post-treatment
- Phase 1& Phase 2a: Electrocardiogram (ECG) parametersUp to follow-up period, approximately 1 year post-treatment
- Phase 1& Phase 2a: Eastern Cooperative Oncology Group (ECOG) performance status (PS)Up to follow-up period, approximately 1 year post-treatment
- Phase 1& Phase 2a: left ventricular ejection fraction (LEVF)Up to follow-up period, approximately 1 year post-treatment
- Phase 1: Maximum Tolerated Dose (MTD) of DB-1311/BNT324Up 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/BNT324Up 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 investigatorUp 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.