ClinicalTrials.gg
RecruitingNCT07705035Updated Oct 27, 2026

DBC-664 in Adult Patients With Solid Tumors

A Phase 1 interventional study of DBC-664 in Malignant Germ Cell Tumor, Lung Adenocarcinoma and Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma, sponsored by Duboce Biopharmaceuticals, Inc.. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Duboce Biopharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Updated Oct 27, 20262 sites addedGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
210
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 206 studies in Adenocarcinoma of Lung with a site in United States — 16 open to participants now, 31 under way, 2 of them phase 3. Adenocarcinoma of Lung · United States.

Planned enrollment
30th of 179
210 · median 50
Started
2026
with 2 others
Phase 1
46 of 206
6 open now
Primary completion
2030-04
later than 27 of 30 live
Registered
206th of 206
by date

Among the 206 studies in Adenocarcinoma of Lung with a site in United States, this one is the 30th largest by planned enrollment of the 179 interventional ones that give a count, is one of 3 that started in 2026, is one of 46 in phase 1, reaches primary completion later than 27 of the 30 other live ones, and was the 206th registered.

Adenocarcinoma of Lung

418 studies on the registry are indexed under Adenocarcinoma of Lung; 79 are open to participants now.

Browse Adenocarcinoma of Lung studies →

Open to participants now

16 of the 206 studies in Adenocarcinoma of Lung with a site in United States are open now. Recruiting first, the newest first:

10 more — sign in →

All 16 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 58 Adenocarcinoma of Lung studies recruiting now, 36 (62%) set no upper age limit and 10 (17%) stop at 75 or younger; 4 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 206 studies in Adenocarcinoma of Lung with a site in United States, or all of them as a file.
02

Study summary

DBC-664-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamic, and preliminary anti-tumor activity of DBC-664 in patients with endometrial cancer, ovarian cancer, and other advanced solid tumors . This study is divided into 2 parts: Phase-1a Dose Escalation (Part 1), and Phase-1b Dose Expansion (Part 2). In each part, patients who meet specific eligibility criteria will be enrolled.

03

Conditions studied

  • Malignant Germ Cell Tumor
  • Lung Adenocarcinoma
  • Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma
  • Urothelial Carcinoma
  • Endometrial Adenocarcinoma
  • Ovarian Adenocarcinoma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Must be ≥18 years of age at the time consent is signed.
  • Has a or cytologically confirmed unresectable recurrent locally advanced or solid tumor
  • Has per v1.1 (or 1.1 for patients with pleural mesothelioma), as assessed by the local site Investigator/radiology.

Exclusion criteria

Exclusion Criteria:

  • Has a diagnosis of immunodeficiency.
  • Has had a prior stem cell, bone marrow, or organ transplant.
  • Has a known history of (HIV) infection.
  • Has active or chronic virus (HBV), or virus (HCV) infection.
  • Has an active disease (non-immunotherapy induced conditions) that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, , or drugs).
  • Has a history of (noninfectious) pneumonitis that required steroids or current active pneumonitis/interstitial lung disease.
  • Has symptomatic visceral spread of disease that poses a risk of life-threatening complications in the short term, per Investigator's opinion (including massive uncontrolled effusions [pleural, pericardial, peritoneal], pulmonary lymphangitis, and over 50% liver involvement).
  • Has known active central nervous system (CNS) and/or carcinomatous meningitis. Individuals with previously treated may participate provided they are radiologically stable (ie, without evidence of progression for at least 2 weeks by repeat imaging [note that the repeat imaging should be performed during study Screening]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • Has a history of a previous secondary within 3 years of Screening (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative therapy or other localized, low-grade tumors deemed cured, or whose natural history does not have the potential to interfere with the safety or efficacy assessments of the current study and not treated with systemic anticancer therapy [except hormonal therapy]).
  • Has a known psychiatric or substance abuse disorder that would interfere with the individuals' ability to cooperate with the requirements of the study.
Terms in these criteria, in plain language(13)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

iRECIST and mRECIST

Versions of RECIST adapted to particular cases. iRECIST is for immunotherapy, where a tumour can look bigger for a while before it shrinks, so growth has to be confirmed on a later scan. mRECIST usually means the version for liver cancer (hepatocellular carcinoma), which measures only the part of a tumour that still has a blood supply.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    Part 1 (Dose Escalation)

    Participants will receive DBC-664 to determine the recommended dose for expansion (RDE) regimen.

    Biological: DBC-664

  • Experimental
    Part 2 (Dose Expansion)

    Participants will receive DBC-664 at the RDE as determined in Part 1 of the study to confirm the safety and anti-tumor activity.

    Biological: DBC-664

Interventions

  • BiologicalDBC-664

    DBC-664 will be administered intravenously.

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability

    The safety and tolerability of DBC-664 in patients with solid tumor measured by frequency and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), adverse events of special interest (AESIs), adverse events (AEs) leading to dose interruption and of adverse events (AEs) leading to treatment discontinuation

    Time frame: 2 years

  2. Determine Recommended Dose for Expansion

    To determine the maximum tolerated dose (MTD) and/or select the recommended dose(s) for expansion (RDE\[s\]) of DBC-664

    Time frame: 1 year

  3. Characterize Pharmacokinetics

    To characterize the pharmacokinetics (PK) of DBC-664 with Cmax following administration

    Time frame: 2 years

07

Study locations

7 of 7 sites recruiting
08

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Apr 2030, 44 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 29, 2026
First posted
Jul 15, 2026
StartActual
Jul 17, 2026
Primary completionEst.
Apr 1, 2030
CompletionEst.
Apr 1, 2030
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added
Show 2 added (2 United States)
  • START San Antonio · San Antonio, United States
  • Washington University School of Medicine · St Louis, United States
across 2 updates, Sep 29, 2026 – Oct 27, 2026
Show all 2 updates
  1. Oct 27, 2026
    1 site added
    Show site
    • Washington University School of Medicine · St Louis, United States
  2. Sep 29, 2026
    1 site added
    Show site
    • START San Antonio · San Antonio, United States

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07705035
Lead sponsor
Duboce Biopharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jul 15, 2026
Start date
Jul 17, 2026
Primary completion
Apr 1, 2030 (estimated)
Completion
Apr 1, 2030 (estimated)
Last update
Oct 27, 2026

Study contacts

Lisa Knapp
Contact
lknapp@tcglsoleil.com
+1 (650) 442-3367

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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