OncoMatch/Clinical Trials/NCT05914116
A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
Is NCT05914116 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments for advanced solid tumors.
Treatment: DB-1311 · Lopinavir and Ritonavir Tablets · itraconazole · Enzalutamide · Abiraterone — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Tumor Agnostic
Biomarker criteria
Required: CD276 expression (testing required; no minimum threshold for eligibility) (testing required; no eligibility threshold specified)
willing to provide pre-existing resected tumor samples or undergo fresh tumor biopsy for the measurement of B7-H3 level and other biomarkers if no contraindication. Note: there is no minimum B7-H3 expression level mandatory for entry into the study.
Disease stage
Required: Stage IV, STAGE III
unresectable advanced/metastatic solid tumor; measurable disease as assessed by RECIST 1.1 (RANO 2.0 for GBM subjects)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — advanced/unresectable or metastatic NSCLC
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
Must have received: anti-PD-1 therapy — advanced/unresectable or metastatic NSCLC, melanoma, HCC, cervical cancer
Previously treated with a PD-1 or PD-L1 inhibitor
Must have received: anti-PD-L1 therapy — advanced/unresectable or metastatic NSCLC, melanoma, HCC, cervical cancer
Previously treated with a PD-1 or PD-L1 inhibitor
Must have received: docetaxel (docetaxel) — CRPC
Having received prior docetaxel (before or after an AR-targeted therapy). Docetaxel rechallenge was allowed.
Must have received: novel hormone therapy — CRPC
Having received prior novel hormone therapy.
Must have received: systemic chemotherapy doublet (paclitaxel, cisplatin, carboplatin, topotecan, bevacizumab) — cervical cancer
Has experienced disease progression during or after treatment with a standard of care systemic chemotherapy doublet, or platinum-based therapy (if eligible), defined as either: d. paclitaxel + cisplatin + bevacizumab + anti-PD-(L)1 agent, or e. paclitaxel + carboplatin + bevacizumab + anti-PD-(L)1 agent, or f. paclitaxel + topotecan + bevacizumab + anti-PD-(L)1 agent
Cannot have received: B7-H3 targeted therapy
Prior treatment with B7-H3 targeted therapy
Cannot have received: antibody-drug conjugate
Exception: with topoisomerase inhibitor
Prior treatment with antibody drug conjugate with topoisomerase inhibitor (e.g., trastuzumab deruxtecan)
Cannot have received: TOP I inhibitor (irinotecan, topotecan)
Prior treatment regimens with irinotecan, topotecan or any other TOP I inhibitor including investigational TOP I inhibitors are not allowed
Lab requirements
Blood counts
adequate organ function within 7 days prior to Day 1 of Cycle 1
Kidney function
adequate organ function within 7 days prior to Day 1 of Cycle 1
Liver function
Has a Child-Pugh class A liver score within 7 days of first dose of study drug (HCC subjects); adequate organ function within 7 days prior to Day 1 of Cycle 1
Cardiac function
Has LVEF ≥ 50% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days before enrollment; no symptomatic CHF (NYHA II-IV), no serious cardiac arrhythmia requiring treatment, no MI or unstable angina within 6 months, QTcF ≤ 470 ms
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 a Child-Pugh class A liver score within 7 days of first dose of study drug (HCC subjects).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site 111 · Tucson, Arizona
- Research Site 125 · Los Angeles, California
- Research Site 133 · Los Angeles, California
- Research Site 103 · Los Angeles, California
- Research Site 128 · Santa Monica, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05914116 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior B7-H3 targeted therapy, antibody-drug conjugate, TOP I inhibitor disqualifies patients from enrollment.
Does this trial require CD276?
Yes, CD276 expression (testing required; no minimum threshold for eligibility) is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV or STAGE III is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify