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DB-1311 in Combination with BNT327 or DB-1305 for Patients with Advanced or Metastatic Solid Tumors

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying people with advanced or metastatic solid tumors, which are cancers that have spread from the place where they started. The cancers being studied include non-small cell lung cancer (NSCLC), cervical cancer, melanoma, hepatocellular carcinoma (a type of liver cancer), ovarian cancer, and squamous cell carcinoma of the head and neck. The trial is testing DB-1311 together with either BNT327 or DB-1305, both given through a vein. The purpose of the study is to find the best dose and to learn how safe these drug combinations are in these cancers.

The study has more than one part. In the first part, small groups of people receive the drug combinations so that researchers can watch for side effects and choose a dose that can be used more widely. In the later part, more people receive the combinations to learn more about how the treatment works in the different cancer groups and to compare dose options in some groups. Because this is an open-label trial, everyone knows which treatment is being given.

During the trial, the treatment is given over time, and participants are followed closely while they are receiving it and for a period afterward. Doctors check for side effects, how well the cancer seems to respond, and how the body handles the drugs. The study includes people with several cancer types, and the treatment plan may differ depending on the cancer group and the study part.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Start of trial treatment

    After you join the study, you begin treatment with DB-1311 given by intravenous infusion, which means it is delivered into a vein.

    You also receive one of the study partner medicines by intravenous infusion: either BNT327 or DB-1305.

    The source data lists the dose for BNT324, BNT325/DB-1305, and BNT327 as 00 mg/kg. No other dose, frequency, or treatment length is specified in the source data for these medicines.

  2. Step 2

    Safety checks during treatment

    During treatment, your health is checked for safety and tolerability, which means how well you handle the study medicines.

    The study looks for dose limiting toxicities, also called DLTs. These are side effects that may limit how much medicine can be given.

    The study also records treatment-emergent adverse events, also called TEAEs, which are side effects that start or become worse after treatment begins.

    The study also records treatment-emergent serious adverse events, also called TESAEs, which are serious side effects that occur after treatment begins.

  3. Step 3

    Dose selection part of the study

    In part 1, the study uses your safety results to determine the recommended phase 2 dose, also called RP2D. This is the dose planned for later study use.

    One dose decision is for DB-1311 combined with BNT327.

    Another dose decision is for DB-1311 combined with DB-1305.

    In the randomized dose optimization part, the study also determines the best dose of DB-1311 with BNT327 and the best dose of DB-1311 with DB-1305 by looking at safety and how well the treatment works.

  4. Step 4

    Checks of how the treatment is working

    The study measures how well the treatment works by looking for tumor shrinkage or disappearance.

    A complete response, or CR, means no signs of cancer are seen.

    A partial response, or PR, means the cancer has shrunk.

    The study uses RECIST v1.1, which is a standard way to measure tumor changes on scans and other assessments.

    The study records objective response rate, or ORR, which is the proportion of participants with a confirmed CR or PR.

    The study also measures duration of response (DoR), disease-control rate (DCR), time to response (TTR), progression-free survival (PFS), and overall survival (OS).

    For participants with platinum-resistant ovarian cancer, the study also checks CA-125, a blood marker that can help show how the cancer is responding.

  5. Step 5

    Laboratory and immune checks

    The study measures how the study medicines move through your body. This is called pharmacokinetics, or PK.

    For DB-1311, the study measures the antibody-drug conjugate, the total antibody, and unconjugated P1021. An antibody-drug conjugate is a medicine made by linking an antibody to a drug.

    The study also checks for anti-drug antibodies, or ADA. These are antibodies your body may make against the study medicine.

    The study records both ADA prevalence, which means how many participants are ADA positive at any time, and ADA incidence, which means how many participants develop ADA after treatment starts.

    In part 2, the study also measures total anti-B7H3 antibody and unconjugated P1021.

Who can join the trial?

14 criteria

  • Be an adult, meaning at least 18 years old, or meet the minimum age allowed by local rules when signing the consent form.
  • Have one of the cancers included in the study: non-small cell lung cancer, cervical cancer, melanoma (skin cancer that starts in pigment cells), hepatocellular carcinoma (a type of liver cancer), ovarian cancer, or squamous cell carcinoma of the head and neck.
  • Have at least one measurable tumor, meaning a cancer area that the study doctor can measure using standard imaging rules.
  • Have an expected life expectancy of at least 3 months.
  • Have an ECOG performance status of 0 to 1, which means being fully active or only slightly limited in daily activities.
  • Have adequate organ function within 7 days before joining the study, meaning the main organs are working well enough for treatment.
  • Have had enough time since the last treatment before starting the study treatment, as required by the study rules.
  • Be able to understand the study procedures and risks, sign the written consent form, and agree to follow the study visits and tests.
  • If a person of childbearing potential is a woman who could become pregnant, have a negative blood pregnancy test before joining.
  • If a person of childbearing potential is a woman who could become pregnant, agree to use a highly effective form of birth control and require male partners to use condoms from the time of consent until the required time after the last study dose.
  • If a woman of childbearing potential, agree not to donate eggs for assisted reproduction from the time of consent until the required time after the last study dose.
  • If a fertile male or a male who could still father a child, agree to use condoms and ask female partners to use a highly effective form of birth control from the time of consent until the required time after the last study dose.
  • If a fertile male or a male who could still father a child, agree not to donate sperm from the time of consent until the required time after the last study dose.
  • Meet any additional cohort or arm specific requirements listed in the study rules.

Who cannot join the trial?

11 criteria

  • Having had previous treatment with a B7H3-targeted therapy (a treatment that is made to attack the B7H3 target on cancer cells).
  • Having had previous treatment with an antibody-drug conjugate that contains a topoisomerase inhibitor, such as trastuzumab deruxtecan. An antibody-drug conjugate is a drug that links an antibody to a cancer-killing medicine.
  • Being a candidate for locoregional treatment that could likely remove the cancer completely or almost completely and give long-term control, such as surgery, focused radiation, or tumor ablation. Tumor ablation means destroying the tumor with heat, cold, or another method.
  • Having an uncontrolled medical, mental, or social problem, or substance abuse, that could make the study unsafe, make it hard to follow study procedures, or affect the study results.
  • Being considered a vulnerable person under clinical trial rules, meaning someone whose choice to join could be unfairly influenced. This includes trial staff, sponsor staff, vendor staff, and their family members or dependents.
  • Having an uncontrolled illness that is already present or develops during the study, if the investigator thinks it makes trial participation unsafe or makes it hard to follow the study plan.
  • Having an uncontrolled or serious disease or disorder, or a past history of certain diseases or disorders, as described in the study protocol.
  • Having side effects from previous cancer treatment that have not improved to Grade 1 or back to baseline. Grade 1 means mild side effects. Hair loss is the only exception. Side effects that remain but are stable, such as a feeding tube or hormone replacement, may be allowed if they are not expected to increase risk.
  • Having a history of allergy, hypersensitivity (an overreaction by the immune system), or intolerance to the study drugs or any of their ingredients.
  • Having had another primary cancer within the past 3 years, except for certain cancers that were completely removed or cured, such as some non-melanoma skin cancers or in-situ disease. In-situ disease means very early cancer that has not spread into deeper tissue.
  • Using any investigational medicinal product within 28 days before the first study dose, or within five half-lives of that drug if that is longer. An investigational medicinal product is a drug being tested in a study. This also includes being in the active treatment phase of another interventional clinical trial, or having already been randomized or treated in a previous trial with the same study drugs.
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Investigated drugs

  • BNT324

    is an experimental medicine given through a vein. It is being tested in this trial to see how safe it is and how well it works when used with other cancer treatments in people with advanced or spread-out solid tumors.

  • BNT325/DB-1305

    is an experimental antibody-drug treatment given through a vein. It is designed to find and attach to a protein called TROP2, which is found on some cancer cells, and then deliver a cancer-killing drug into those cells. In this trial, it is being studied as part of combination treatment to see how safe it is and whether it can help control the cancer.

  • BNT327

    is an experimental medicine given through a vein. It is being studied together with DB-1311 to see whether the combination is safe and whether it can help treat advanced or metastatic solid tumors.

What is already known about the treatment

  • BNT324

    BNT324 is given by intravenous infusion as a powder that is first prepared into a solution before use. It is an experimental medicine and is not yet an established treatment in regular medical practice, so its full benefits and risks are still being studied. Based on its use in cancer research, it is intended to help treat advanced solid tumors by targeting cancer cells and slowing their growth. Its exact action at the molecular level is still being investigated, but it belongs to the group of targeted cancer medicines designed to act more directly on tumor cells than standard chemotherapy.

  • BNT325/DB-1305

    BNT325/DB-1305 is given by intravenous infusion after the lyophilized powder is prepared into a solution. It is an experimental cancer medicine in current medical research and is not yet a routine treatment, although similar medicines in this class are widely studied for hard-to-treat cancers. It is designed for cancers that may include non-small cell lung cancer, cervical cancer, melanoma, hepatocellular carcinoma, ovarian cancer, and head and neck squamous cell carcinoma. This medicine is a monoclonal antibody-drug conjugate that binds to the TROP2 protein on cancer cells, is taken into the cell, and then releases a toxic drug that damages the cell’s DNA and helps kill the cancer cell.

  • BNT327

    BNT327 is given by intravenous infusion as a powder that is prepared into a solution before administration. It is an experimental medicine in clinical research and is not yet approved as a standard treatment, but it is being studied in combination with other cancer medicines for advanced solid tumors. Its main use is in cancer treatment, especially in patients with non-small cell lung cancer, cervical cancer, melanoma, hepatocellular carcinoma, ovarian cancer, and head and neck squamous cell carcinoma. It belongs to the class of targeted cancer medicines, and at the molecular level it is designed to interfere with signals that tumors use to grow and survive, helping the immune system or other treatments work better against the cancer.

Investigated diseases

  • Non-Small Cell Lung Cancer

    A group of lung cancers that includes several related types, most commonly adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It usually begins in the cells lining the airways or air sacs of the lung and tends to grow and spread more slowly than small cell lung cancer. As it progresses, it can enlarge within the lung, spread to nearby lymph nodes, and later involve other organs.

  • Cervical Cancer

    A cancer that starts in the cervix, the lower part of the uterus that connects to the vagina. It often develops gradually from abnormal cell changes before becoming invasive cancer. As it progresses, it may grow deeper into the cervix and spread to nearby tissues or other parts of the body.

  • Melanoma

    A cancer that begins in melanocytes, the cells that make pigment in the skin. It often starts as a changing mole or a new dark spot on the skin, but it can also appear in the eyes or other tissues. As it progresses, it can grow deeper into the skin and spread to lymph nodes and distant organs.

  • Hepatocellular Carcinoma

    The most common type of primary liver cancer, arising from the main cells of the liver. It usually develops in a liver that has been damaged over time, often with long-term scarring or inflammation. As it progresses, it may form one or more tumors in the liver and later spread to nearby structures or other parts of the body.

  • Ovarian Cancer

    A cancer that starts in the ovaries, which are the organs that produce eggs and hormones. It often begins with small, unnoticed changes on the surface of the ovary or nearby tissue. As it progresses, it may spread within the pelvis and abdomen and later involve other organs.

  • Squamous Cell Carcinoma of Head and Neck

    A cancer that begins in the thin, flat squamous cells lining the mouth, throat, nose, or voice box. It usually starts as a local growth in one of these areas and may slowly enlarge over time. As it progresses, it can spread to nearby tissues and lymph nodes in the neck, and sometimes to more distant parts of the body.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523895-22-00Protocol codeDB-1311-201Estimated enrolment409 patientsSponsorDualitybio Inc.

sourced from the EU Clinical Trials Register and site verification

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