What is DB-1311 studying for advanced or metastatic solid tumors?

DB-1311 is being studied in combination with other drugs to evaluate its safety and preliminary effectiveness in adults with various advanced or metastatic solid tumors. The trial aims to find safe dose levels and observe tumor responses to these combinations. This research is sponsored by DualityBio Inc.

Who may be eligible for this solid tumor clinical trial?

Adults aged 18 years or older with advanced or metastatic solid tumors such as liver, cervical, melanoma, ovarian, lung, pancreatic, breast, colorectal, or prostate cancer may be eligible. Participants must have measurable tumors, a good performance status, and adequate organ function. Please review eligibility criteria for more details.

Is there any cost to participate in this solid tumor clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 2

Age: 18Years +

All Genders

ID06953089

Phase II study of DB-1311 combined with BNT327 or DB-1305 for adults with advanced or metastatic solid tumors

Led by DualityBio Inc. · Updated on 2026-05-22

450

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and preliminary effectiveness of DB-1311 combined with BNT327 or DB-1305 in adults with advanced or metastatic solid tumors. This phase II, open-label, multicenter trial includes participants with various cancers such as hepatocellular carcinoma, cervical cancer, melanoma, head and neck squamous cell carcinoma, ovarian cancer, non-small cell lung cancer, pancreatic ductal carcinoma, breast cancer, colorectal cancer, and metastatic castration-resistant prostate cancer. The trial involves escalating doses of the drug combinations DB-1311BNT324 with either BNT327 or DB-1305BNT325. These treatments are given intravenously to define recommended phase 2 doses in different patient groups. Participants are assigned to one of several study arms based on their cancer type and dose level, with treatment continuing as per protocol. The study aims to establish safe dosing and observe treatment responses over time. Participants will undergo regular assessments including monitoring for dose-limiting toxicities and adverse events up to 72 months. The study will measure tumor response using RECIST 1.1 criteria and evaluate overall survival, progression-free survival, and other outcomes. Blood samples will be collected to study drug concentrations and immune responses. The trial includes follow-up visits to monitor safety and effectiveness throughout the study duration.

CONDITIONS

Brief Title

DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 60 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 60 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): Confirmed diagnosis of ovarian, primary peritoneal, or fallopian tube cancer with high-grade serous histology and platinum-resistant disease.
For HNSCC patients: Histologically or cytologically confirmed recurrent or disseminated head and neck squamous cell carcinoma not curable by local therapies.
For NSCLC patients: Pathologically documented Stage IIIB, IIIC, or IV NSQ NSCLC without EGFR-sensitizing mutations or ALK rearrangements or other onco-driver mutations.
For PSOC: Radiographically documented disease recurrence or progression more than 6 months after last platinum-based chemotherapy.
For PDAC: Histologically or cytologically confirmed metastatic pancreatic ductal carcinoma with progression after at least one prior systemic treatment.
For breast cancer: Pathologically or cytologically documented HR-positive unresectable or metastatic breast cancer with HER2-low, HER2-ultralow or HER2-negative expression, or unresectable metastatic triple negative breast cancer.
For mCRC: Metastatic colorectal cancer relapsed or progressed after prior systemic therapies as clinically indicated.
For mCRPC: Histologically or cytologically confirmed adenocarcinoma of the prostate and metastatic castration resistant prostate cancer.

You will not qualify if you...

Prior treatment with B7H3 targeted therapy.
Prior treatment with antibody-drug conjugate containing a topoisomerase inhibitor.
Candidate for locoregional treatment expected to induce complete or near complete response.
Uncontrolled concomitant or intercurrent illness that limits compliance or increases risk.
Uncontrolled or significant cardiovascular disease.
Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring drainage or specialized therapy.
History of non-infectious interstitial lung disease or pneumonitis.
Autoimmune, connective tissue, or inflammatory disorders.
Spinal cord compression or active central nervous system metastases.
Unresolved toxicities from previous anticancer therapy not resolved to Grade 60 1 or baseline, except alopecia.

Research Team

Jay Ma

Qiaoli Jiang

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Phase II study of DB-1311 combined with BNT327 or DB-1305 for adults with advanced or metastatic solid tumors

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria