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HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST TROP2 CONJUGATED TO N-((7S,15S)-7-BENZYL-17-(((1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL-10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12H-BENZO[DE]PYRANO[3′,4′:6,7] INDOLIZINO[1,2-B]QUINOLIN-1-YL)AMINO)-15-METHYL-2,5,8,11,17-PENTAOXO-14-OXA-3,6,9,12-TETRAAZAHEPTADECYL)-6-(2,5-DIOXO-2,5-DIHYDRO-1H-PYRROL-1-YL)HEXANAMIDE

Clinical trials are studying HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST TROP2 CONJUGATED TO N-((7S,15S)-7-BENZYL-17-(((1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL-10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12H-BENZO[DE]PYRANO[3′,4′:6,7] INDOLIZINO[1,2-B]QUINOLIN-1-YL)AMINO)-15-METHYL-2,5,8,11,17-PENTAOXO-14-OXA-3,6,9,12-TETRAAZAHEPTADECYL)-6-(2,5-DIOXO-2,5-DIHYDRO-1H-PYRROL-1-YL)HEXANAMIDE in people with advanced or metastatic solid tumors. The trials aim to check safety, tolerability, and early signs of benefit, including the best dose to use in combination studies.

Table of contents

Clinical trials overview

The available trial is an interventional Phase 2 study of HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST TROP2 CONJUGATED TO N-((7S,15S)-7-BENZYL-17-(((1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL-10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12H-BENZO[DE]PYRANO[3′,4′:6,7] INDOLIZINO[1,2-B]QUINOLIN-1-YL)AMINO)-15-METHYL-2,5,8,11,17-PENTAOXO-14-OXA-3,6,9,12-TETRAAZAHEPTADECYL)-6-(2,5-DIOXO-2,5-DIHYDRO-1H-PYRROL-1-YL)HEXANAMIDE in advanced or metastatic solid tumors.[1]

The study is authorised and plans to enroll 409 participants.[1]

Who the trials are for

This study targets people with advanced or metastatic solid tumors, which means cancers that have grown locally or spread to other parts of the body.[1]

The listed cancer types are non-small cell lung cancer, cervical cancer, melanoma, hepatocellular carcinoma, ovarian cancer, and squamous cell carcinoma of the head and neck.[1]

Study design and phases

The trial is split into two parts.[1] In Part 1, the main goal is to find the recommended Phase 2 dose, which is the dose chosen for later study based on safety results.[1]

Part 1 also checks safety and tolerability in the targeted participant groups, using dose limiting toxicities, treatment-emergent adverse events, and treatment-emergent serious adverse events.[1]

In Part 2, the study looks at efficacy, which means how well the treatment works, in targeted participant populations.[1]

Part 2 includes arms that study HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST TROP2 CONJUGATED TO N-((7S,15S)-7-BENZYL-17-(((1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL-10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12H-BENZO[DE]PYRANO[3′,4′:6,7] INDOLIZINO[1,2-B]QUINOLIN-1-YL)AMINO)-15-METHYL-2,5,8,11,17-PENTAOXO-14-OXA-3,6,9,12-TETRAAZAHEPTADECYL)-6-(2,5-DIOXO-2,5-DIHYDRO-1H-PYRROL-1-YL)HEXANAMIDE with BNT327 and DB-1305, including randomized dose optimization arms.[1]

What the trials measure

The main safety endpoint in Part 1 is the number of participants with dose limiting toxicities, or side effects that help define the highest safe dose.[1]

The study also measures treatment-emergent adverse events and treatment-emergent serious adverse events in both parts of the trial.[1]

The main efficacy endpoint in Part 2 is objective response rate (ORR), which is the proportion of participants with a confirmed complete response or partial response as their best overall response.[1]

ORR is measured using RECIST v1.1, a standard rule set for checking how tumors change on scans.[1]

Key patient-focused points

  • These trials focus on advanced cancers, so they are aimed at people whose disease is already far along.[1]
  • The study is not only about safety; it also looks for early signs that the treatment combinations may help control cancer.[1]
  • The trial includes several cancer types, so it is a multi-cancer study rather than one limited to a single disease.[1]
  • The randomized dose optimization arm is used to help choose the best dose for further testing.[1]
Trial ID Phase Condition studied Status Enrollment
2025-523895-22-00 Phase 2 Advanced/metastatic solid tumors, including NSCLC, cervical cancer, melanoma, HCC, ovarian cancer, and squamous cell carcinoma of the head and neck Authorised 409

FAQ

  • Who can take part in these trials? The trials include people with advanced or metastatic solid tumors. The listed cancer types are non-small cell lung cancer, cervical cancer, melanoma, hepatocellular carcinoma, ovarian cancer, and squamous cell carcinoma of the head and neck.
  • What is being studied? The studies are testing HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST TROP2 CONJUGATED TO N-((7S,15S)-7-BENZYL-17-(((1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL-10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12H-BENZO[DE]PYRANO[3',4':6,7] INDOLIZINO[1,2-B]QUINOLIN-1-YL)AMINO)-15-METHYL-2,5,8,11,17-PENTAOXO-14-OXA-3,6,9,12-TETRAAZAHEPTADECYL)-6-(2,5-DIOXO-2,5-DIHYDRO-1H-PYRROL-1-YL)HEXANAMIDE in combination with BNT327 or DB-1305.
  • What phase are the trials in? The study is in Phase 2. This means it is looking more closely at safety and early effectiveness after earlier testing.
  • What are the main goals of the trials? The main goals are to find the recommended Phase 2 dose, check safety and tolerability, and measure early efficacy. The study also looks at objective response rate, which means how many participants have a confirmed tumor shrinkage or disappearance.
  • What safety and outcome measures are used? The trials measure dose limiting toxicities, treatment-emergent adverse events, and treatment-emergent serious adverse events. They also measure objective response rate using RECIST v1.1, which is a standard way to judge tumor response.

Ongoing Clinical Trials on HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST TROP2 CONJUGATED TO N-((7S,15S)-7-BENZYL-17-(((1S,9S)-9-ETHYL-5-FLUORO-9-HYDROXY-4-METHYL-10,13-DIOXO-2,3,9,10,13,15-HEXAHYDRO-1H,12H-BENZO[DE]PYRANO[3′,4′:6,7] INDOLIZINO[1,2-B]QUINOLIN-1-YL)AMINO)-15-METHYL-2,5,8,11,17-PENTAOXO-14-OXA-3,6,9,12-TETRAAZAHEPTADECYL)-6-(2,5-DIOXO-2,5-DIHYDRO-1H-PYRROL-1-YL)HEXANAMIDE

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

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

Glossary

  • Advanced solid tumor: A solid cancer that has grown far or spread, and is harder to treat than an early-stage cancer.
  • Metastatic: Cancer that has spread from where it started to other parts of the body.
  • Non-small cell lung cancer (NSCLC): A common type of lung cancer.
  • Cervical cancer (CC): Cancer that starts in the cervix, the lower part of the uterus.
  • Melanoma: A serious type of skin cancer.
  • Hepatocellular carcinoma (HCC): The most common type of primary liver cancer.
  • Ovarian cancer (OC): Cancer that starts in the ovaries.
  • Squamous cell carcinoma of head and neck: A cancer that starts in the flat cells lining the head and neck area.
  • Phase 2: A trial stage that looks at safety and early signs of how well a treatment works.
  • Dose limiting toxicities (DLTs): Side effects that are serious enough to help define the highest safe dose.
  • Treatment-emergent adverse events (TEAEs): Health problems that appear or get worse after treatment starts.
  • Treatment-emergent serious adverse events (TESAEs): Serious health problems that appear or get worse after treatment starts.
  • Objective response rate (ORR): The percentage of participants whose tumors shrink or disappear in a confirmed way.
  • RECIST v1.1: A standard set of rules used to measure how a tumor changes on scans.
  • Recommended Phase 2 dose (RP2D): The dose chosen for later studies because it appears suitable based on safety and early study results.