DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Cervical Cancer
Liver Cancer / Hepatoblastoma
Lung Cancer
Melanoma
18 Years and older, Male and Female
DB-1311-201 (primary)
NCI-2025-05085
Summary
A Phase II, Multicenter, Open-Label Trial of DB-1311 in combination with BNT327 or
DB-1305 in Participants with Advanced/Metastatic Solid Tumors
Objectives
This is a phase II, multicenter, open-label, two-part trial designed to evaluate the
safety and preliminary efficacy of DB-1311 in combination with BNT327 or DB-1311 in
combination with DB-1305 in targeted participants.
Participants with recurrent, progressive as well as advanced, metastatic hepatocellular
carcinoma (HCC), cervical cancer (CC), melanoma, head and neck squamous cell carcinoma
(HNSCC), platinum-resistant ovarian cancer (PROC) or non-small cell lung cancer (NSCLC)
are eligible to participate in the trial.
Eligibility
- Adults aged = 18 years or acceptable age according to local regulations at the time of voluntarily signing informed consent.
- At least one measurable lesion as assessed by the Investigator according to RECIST v1.1 criteria.
- Has a life expectancy of = 3 months.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
- Has adequate organ function within 7 days prior to enrollment/randomization,
- Has adequate treatment washout period prior to the first dose of trial treatment.
- For HCC patients: Histological/cytological confirmed diagnosis of HCC or clinically confirmed diagnosis of HCC; Has a Child-Pugh class A liver score.
- For CC patients: Has persistent, recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology
- For Melanoma patients: Histologically or cytologically confirmed diagnosis of unresectable Stage III or metastatic melanoma.
- For PROC patients (Cohort A): Participants must have a confirmed diagnosis of OC, primary peritoneal cancer, or fallopian tube cancer, all of which with high-grade serous histology. Patients must have platinum-resistant disease.
- For HNSCC patients: Histologically or cytologically confirmed recurrent (recurrent disease that is not amendable to curative treatment with local/ or systemic therapies)/ (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies.
- For NSCLC patients: Pathologically documented Stage IIIB or IIIC NSCLC not amenable for radical surgery or definitive chemoradiation or Stage IV NSQ NSCLC. Not harboring an EGFR-sensitizing mutation or ALK gene rearrangements or other onco-driver gene mutations
Treatment Sites in Georgia
4877 Bill Gardner Pkwy
Locust Grove, GA 30248
Piedmont Cancer Institute – Sandy Springs
755 Mount Vernon Hwy
Suite 320
Atlanta, GA 30328
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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