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RecruitingPhase 1

DBC-664 in Adult Patients With Solid Tumors

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests DBC-664 in people for the first time. It looks at safety, how the body handles the drug, and whether it may fight cancer. It is for adults with advanced solid tumors, including endometrial cancer (cancer of the womb lining) and ovarian cancer.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are at least 18 years old when you sign the consent form.
  • Tests of tissue or cells confirm a solid tumor that cannot be removed by surgery and has come back, grown into nearby areas, or spread to other parts of the body.
  • Your cancer can be measured on scans using the study’s rules.

Who can't join

  • You have a diagnosed weak immune system, a known history of HIV, or an active or long-term hepatitis B or C infection.
  • You have had a stem cell, bone marrow, or organ transplant.
  • You have an active autoimmune disease, where the immune system attacks the body, that needed medicine treating the whole body in the past 2 years. This rule does not cover conditions caused by immune-based cancer treatment.
  • You had lung swelling not caused by infection that needed steroids, or you now have lung swelling or interstitial lung disease, which affects tissue around the lungs’ air sacs.
  • Cancer has spread to organs and causes symptoms that the study doctor thinks could soon be life-threatening.
  • You have active cancer spread to the brain or spinal cord, or cancer in their lining. Previously treated spread to the brain or spinal cord may be allowed if repeat scans during screening show no growth for at least 2 weeks, symptoms are stable, and you have needed no steroids for at least 14 days before the first dose.
  • You had another cancer within 3 years before screening. Exceptions include certain skin cancers or very early cancers treated to cure them, and some low-grade cancers that are cured or will not affect study results and have not needed whole-body cancer treatment other than hormone treatment.
  • You have a known mental health or substance use disorder that would keep you from following the study requirements.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Study sites (6)

CO

MI

NJ

NY

TN

TX