Study of DCC-2812 in Participants With Advanced Genitourinary Cancers
An Open-label, Phase 1 Study of DCC-2812 Monotherapy in Participants With Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer
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 DCC-2812 used alone to learn about its safety and whether it may help treat cancer. It is for people with advanced cancer or cancer that has spread: kidney cancer, cancer of the urinary tract, or prostate cancer that keeps growing despite treatment to lower testosterone.
This is a multicenter clinical trial to evaluate the safety and preliminary activity of the selective general control nonderepressible 2 (GCN2) activator DCC-2812 as monotherapy in advanced/metastatic renal cell carcinoma (RCC), urothelial carcinoma, and castration-resistant prostate cancer.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have confirmed advanced or spreading kidney cancer, urinary tract cancer, or prostate cancer that keeps growing despite treatment to lower testosterone.
- Be able to take medicine by mouth.
- Have a negative pregnancy test before joining if you can become pregnant.
- Agree to follow the study's birth control rules.
- Have organs that work well enough and suitable levels of electrolytes (salts in the blood).
Who can't join
- Had cancer treatment or an experimental treatment too close to the first dose of DCC-2812, based on the study's timing rules.
- Have a heart that does not work well enough.
- Had major surgery within 28 days before the first dose of the study drug.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Key Inclusion Criteria: * Have confirmed Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer * Able to take oral medication * If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements * Adequate organ function and electrolytes Key Exclusion Criteria: * Received any prior anticancer therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-2812 * Impaired cardiac function * Major surgery within 28 days of the first dose of study drug
Study sites (8)
MA
- Dana-Farber Cancer Institute · Boston, MA 02215Bicky Thapa, MD · Study contact · 617-632-3000 · bicky_thapa@dfci.harvard.eduBicky Thapa, MD · Principal investigatorMore trials in Boston
MI
- University of Michigan · Ann Arbor, MI 48109 · Study contact · 800-865-1125 · CancerAnswerLine@med.umich.eduUlka Vaishampayan, MD · Principal investigatorMore trials in Ann Arbor
MO
- Washington University School of Medicine · St Louis, MO 63110Hannah Black · Study contact · 314-362-9913 · hannahblack@wustl.eduMelissa Reimers, MD · Principal investigatorMore trials in St Louis
OH
- Cleveland Clinic · Cleveland, OH 44195 · Study contact · 216-444-8311 · GUPTAS5@ccf.orgShilpa Gupta, MD · Principal investigatorMore trials in Cleveland
PA
- Fox Chase Cancer Center · Philadelphia, PA 19111Courtney Lambert, CRN · Study contact · 215-214-3787 · Courtney.lambert@fccc.eduDaniel Geynisman, MD · Principal investigatorMore trials in Philadelphia
TN
- Vanderbilt- Ingram Cancer Center · Nashville, TN 37232Vanderbilt- Ingram Cancer Center Clinical Trials Office (CTO) · Study contact · 1-800-811-8480 · CTIP@VUMC.ORGBrian Rini, MD · Principal investigatorMore trials in Nashville
TX
- NEXT Oncology, Austin · Austin, TX 78758Clinical Trial Navigator · Study contact · 737-610-5180 · hwatson@nextoncology.comAndrae Vandross, MD · Principal investigatorMore trials in Austin
- NEXT Oncology, San Antonio · San Antonio, TX 78229Jordan Georg · Study contact · 210-580-9521 · jgeorg@nextoncology.comIldefonso Rodriguez Rivera, MD · Principal investigatorMore trials in San Antonio