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New drug BDB001 tested in patients whose tumors resisted standard immunotherapy

NCT ID NCT04819373

Disease control Sponsor: Eikon Therapeutics 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called BDB001 in people with advanced solid tumors (like skin, lung, or kidney cancer) that had stopped responding to standard immunotherapy. The goal was to see if BDB001 could shrink tumors or slow their growth. Only one person took part, so results are very limited.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

1 person

The number who actually took part.

Started

Aug 2021

Finished

May 2023

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 Participants are eligible to be included in the study only if all of the following criteria apply: 1. Histologically or cytologically confirmed: Cutaneous SCC, Head and Neck SCC, Melanoma, Merkel Cell Carcinoma, NSCLC, Renal Cell Carcinoma, or Urothelial Carcinoma. Other tumor types will be allowed at Sponsor's discretion. 2. Tumor progression on the most recent line of treatment with anti-PD-1 or anti-PD-L1 mAb as monotherapy or in combination. 3. Eastern Cooperative Oncology Group (ECOG) score of 0 - 2 4. At least 1 lesion with measurable disease at baseline 5. Availability of a lesion for biopsy and consent to allow pre-treatment tumor biopsy. Exclusion Criteria Participants are excluded from the study if any of the following criteria apply: 1. Greater than 4 lines of prior DNA-damaging chemotherapies. 2. Uncontrolled CNS metastases. 3. Active autoimmune disease. Other protocol defined inclusion/exclusion criteria could apply

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Conditions

The condition(s) this trial relates to.

cutaneous neuroendocrine carcinoma head and neck squamous cell carcinoma melanoma neoplasm non-small cell lung carcinoma renal cell carcinoma skin squamous cell carcinoma urothelial carcinoma

As listed by the trial registrant

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

Tumor, solid

Contacts and locations

Locations

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.