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Can a Two-Pronged drug attack Hard-to-Treat tumors?

NCT ID NCT07797907

Disease control Sponsor: Biolojic Design Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This first-in-human trial tests an experimental drug called BD200 in adults with advanced solid tumors that have not responded to standard treatments. BD200 is designed to latch onto two proteins, Trop-2 and Nectin-4, found on many cancer cells, potentially delivering a toxic payload directly to the tumor. The study has two parts: first, to find the safest dose, and second, to see how well the drug shrinks tumors. Researchers will also monitor side effects and how the drug moves through the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BD200, a dual-targeting drug conjugate that binds to Trop-2 and Nectin-4 proteins on cancer cells
What this could lead to
If BD200 proves safe and effective, it could offer a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not work as hoped or may cause unexpected side effects. Success in this trial does not guarantee approval or widespread use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18+ years * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Participant willing to provide tumor biopsies * Measurable disease per RECIST v1.1 * Histologically-confirmed advanced, metastatic, or recurrent solid tumors that is not amenable to surgical resection or other approved therapeutic options * Satisfy requirements for prior treatments per tumor type as outlined in the protocol * Adequate organ function * Agree to contraception requirements as outlined in the protocol Exclusion Criteria: * Any major surgery or traumatic injury prior to enrollment * Unhealed wounds from surgery or injury * Received other therapies within 4 weeks prior to enrollment * Any clinically significant chronic gastrointestinal (GI) disorder * Any clinically significant ascites or liver disease * Any clinically significant pulmonary compromise * Active infection at the time enrollment * Active autoimmune disease * History or active skin disease requiring frequent treatment * Any clinically significant corneal disorder * Active known second malignancy * Any clinically significant cardiac disease * Participants with tumor abutting or eroding a major vessel * Pregnant or lactating or planning to become pregnant * Known hypersensitivity to BD200 or any of its ingredients * Unresolved toxicities from previous anticancer therapy * Participation in a concurrent clinical study in the treatment period * Part A Only: Participant with hepatitis B virus (HBV), hepatitis virus (HCV) or human immunodeficiency virus (HIV) infection Note: Other inclusion and exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumor (phase I)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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