Malignant Germ Cell TumorPhase 1NCT07705035
DBC-664 in Adult Patients With Solid Tumors
A Phase 1 study testing DBC-664 in people with Malignant Germ Cell Tumor and Lung Adenocarcinoma, run by Duboce Biopharmaceuticals, Inc. at 7 sites in United States.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Germ Cell Tumor, Lung Adenocarcinoma, Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma
- What is being tested?
- DBC-664
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 7 sitesUnited States
- Study dates
- 17 Jul 2026to 1 Apr 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be ≥18 years of age at the time consent is signed.
- Has a histologically or cytologically confirmed unresectable recurrent locally advanced or metastatic solid tumor
- Has measurable disease per RECIST v1.1 (or mRECIST 1.1 for patients with pleural mesothelioma), as assessed by the local site Investigator/radiology.
Who cannot join
- Has a diagnosis of immunodeficiency.
- Has had a prior stem cell, bone marrow, or organ transplant.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has active or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Has an active autoimmune disease (non-immunotherapy induced conditions) that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- Has a history of (noninfectious) pneumonitis that required steroids or current active pneumonitis/interstitial lung disease.
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- 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) metastases and/or carcinomatous meningitis. Individuals with previously treated CNS metastases 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 malignancy 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Sarah Cannon Research Institute - Denver HealthONE
Denver, Colorado, 80218
- Recruiting
START New Jersey
East Brunswick, New Jersey, 08816
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
START New York
Lake Success, New York, 11402
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
START San Antonio
San Antonio, Texas, 78229
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1a/1b Open Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of DBC-664 in Adult Patients With Locally Advanced or Metastatic Solid Tumors
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.
- Conditions
- Malignant Germ Cell Tumor, Lung Adenocarcinoma, Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma, Urothelial Carcinoma, Endometrial Adenocarcinoma, Ovarian Adenocarcinoma
- Being tested
- DBC-664
- Medical subject headings
- Adenocarcinoma of Lung, Adenocarcinoma, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBC-664Biological
DBC-664 will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Dose Escalation) | Experimental | Participants will receive DBC-664 to determine the recommended dose for expansion (RDE) regimen. Receives: Biological: DBC-664 |
| Part 2 (Dose Expansion) | Experimental | Participants will receive DBC-664 at the RDE as determined in Part 1 of the study to confirm the safety and anti-tumor activity. Receives: Biological: DBC-664 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
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
Measured: 1 year
Characterize Pharmacokinetics
To characterize the pharmacokinetics (PK) of DBC-664 with Cmax following administration
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start17 Jul 2026
- Primary completion1 Apr 2030 (estimated)
- Study completion1 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Germ Cell TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duboce Biopharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705035
- Sponsor's protocol ID
- DBC-664-ONC-101
- Status last verified
- Aug 2026
- First submitted
- 29 Jun 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Open Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of DBC-664 in Adult Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07705035
- Acronym / sponsor ID
- DBC-664-ONC-101
- Conditions
- Malignant Germ Cell Tumor, Lung Adenocarcinoma, Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma, Urothelial Carcinoma, Endometrial Adenocarcinoma, Ovarian Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Duboce Biopharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 1 Apr 2030 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Dose Escalation) | Experimental | Biological: DBC-664Participants will receive DBC-664 to determine the recommended dose for expansion (RDE) regimen. |
| Part 2 (Dose Expansion) | Experimental | Biological: DBC-664Participants will receive DBC-664 at the RDE as determined in Part 1 of the study to confirm the safety and anti-tumor activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be ≥18 years of age at the time consent is signed.
- Has a histologically or cytologically confirmed unresectable recurrent locally advanced or metastatic solid tumor
- Has measurable disease per RECIST v1.1 (or mRECIST 1.1 for patients with pleural mesothelioma), as assessed by the local site Investigator/radiology.
Key exclusion criteria (10 listed)
- Has a diagnosis of immunodeficiency.
- Has had a prior stem cell, bone marrow, or organ transplant.
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has active or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- Has an active autoimmune disease (non-immunotherapy induced conditions) that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBC-664DBC-664 will be administered intravenously. | Biological | Part 1 (Dose Escalation), Part 2 (Dose Expansion) |
Primary outcome
Safety and Tolerability
Time frame: 2 years
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
Determine Recommended Dose for Expansion
Time frame: 1 year
To determine the maximum tolerated dose (MTD) and/or select the recommended dose(s) for expansion (RDE[s]) of DBC-664
Characterize Pharmacokinetics
Time frame: 2 years
To characterize the pharmacokinetics (PK) of DBC-664 with Cmax following administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DBC-664 in people with Malignant Germ Cell Tumor and Lung Adenocarcinoma, run by Duboce Biopharmaceuticals, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Knapp (+1 (650) 442-3367, lknapp@tcglsoleil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.