A Phase Ia/Ib 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
Study Identifier:
DBC-664-ONC-101
CT.gov Identifier:
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Will Be Recruiting
Considering participating in a START clinical trial?
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.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Bladder
Non-Small Cell Lung Cancer
Ovarian
Renal
Gastric
Endometrial
Digestive & Intestinal
Unmapped
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part 1 (Dose Escalation)
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Drug: Participants will receive DBC-664 to determine the recommended dose for expansion (RDE) regimen.
Drug: Drug: DBC-664
Drug: DBC-664 will be administered intravenously.
Drug: EXPERIMENTAL: Part 2 (Dose Expansion)
Drug: Participants will receive DBC-664 at the RDE as determined in Part 1 of the study to confirm the safety and anti-tumor activity.
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting
Requirements information
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.
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Nehal Lakhani
Status
Recruiting
Condition(s) Treated at Site
Bladder
Non-Small Cell Lung Cancer
Ovarian
Renal
Gastric
Endometrial
Digestive & Intestinal
Unmapped
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Bruno Fang
Status
Recruiting
Condition(s) Treated at Site
Bladder
Non-Small Cell Lung Cancer
Ovarian
Renal
Gastric
Endometrial
Digestive & Intestinal
Unmapped
Location
START New York (Long Island)
Lake Success, NY, United States, 11042
Investigator
Geraldine O'Sullivan Coyne
Status
Recruiting
Condition(s) Treated at Site
Bladder
Non-Small Cell Lung Cancer
Ovarian
Renal
Gastric
Endometrial
Digestive & Intestinal
Unmapped
Location
START San Antonio
San Antonio, TX, United States, 78229
Investigator
Kyriakos Papadopoulos
Status
Recruitment on Hold
Condition(s) Treated at Site
Bladder
Non-Small Cell Lung Cancer
Ovarian
Renal
Gastric
Endometrial
Digestive & Intestinal
Unmapped