An Open-label Dose Escalation and Expansion, Followed by a Phase II Study of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) in Patients With Progressive Metastatic Castrate Resistant Prostate Cancer (mCRPC) (TulmiSTAR-01)
TulmiSTAR-01: A Two-part, Phase I Dose Escalation and Expansion Followed by a Randomized, Open-label Multicenter, Phase II Study to Assess the Safety and Efficacy of the Combination of Tulmimetostat (DZR123) and JSB462 (Luxdegalutamide) vs Standard of Care in Patients With Progressive Metastatic Castrate 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
- Male only
- 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 tulmimetostat (DZR123) with JSB462 (luxdegalutamide) and compares the combination with standard care. It looks at safety and how well treatment works in adult men whose prostate cancer has spread and keeps growing despite very low testosterone levels.
This is a two-part, Phase I/II, open-label, global, multicenter study assessing the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) versus standard of care in participants with progressive metastatic castrate resistant prostate cancer (mCRPC).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You must be a man age 18 or older.
- A tissue or cell test must show prostate adenocarcinoma, a type of prostate cancer, without small cell or neuroendocrine features.
- A CT, MRI, or bone scan must show at least one spot where cancer has spread. The scan must be done within 28 days before treatment or assignment to a study group.
- Your prostate cancer must be getting worse despite very low testosterone levels.
- Your testosterone level must be below 50 ng/dL.
- Your cancer must have worsened after hormone-blocking treatment with abiraterone, enzalutamide, darolutamide, or apalutamide. Parts 1a and 1b require at least one prior treatment; Part 2 requires one.
- Prior chemotherapy limits vary: up to two courses of treatment in Part 1a and one in Part 1b after cancer stopped responding to hormone treatment. Part 2 allows no prior taxane chemotherapy at this stage.
- Chemotherapy given when the cancer still responded to hormone treatment is allowed.
Who can't join
- You cannot have had a PRC2 inhibitor, a drug that blocks proteins such as EZH2, EZH1, or EED.
- You cannot have had a drug that breaks down the androgen receptor, a protein that helps cancer respond to male hormones.
- You cannot have a known allergy or another medical reason you cannot take the study drugs, their ingredients, or similar drugs.
- You cannot have used an experimental drug within 28 days before joining, or longer if the drug takes more time to leave your body.
- Prior radioligand therapy, which delivers radiation to cancer cells, is not allowed after the cancer spread and stopped responding to hormone treatment, except in Part 1a.
- Cancer that spread to the brain or nearby tissues must have been treated and be stable, without symptoms or nerve problems. Steroids cannot be needed to keep brain or nerve function stable. Brain scans may be required.
- One exclusion about cancer stage and PSA, a blood marker for prostate cancer, is unclear and conflicts with who the study is for. Ask the study team to explain it.
- Other study rules may apply.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Key Inclusion Criteria: * Participant is an adult man ≥ 18 years of age. * Participant must have histologically and/or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine or small cell features (current or prior biopsy of the prostate and/or metastatic site). * Participant must have ≥ 1 metastatic lesion that is present on screening/baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to start of treatment (Part 1a dose escalation) or randomization (Part 1b dose expansion and Part 2). * Participant must have progressive mCRPC. * Participant must have a castrate level of serum/plasma testosterone (\< 50 ng/dL or \< 1.7 nmol/L). * Prior ARPI therapy: * Part 1a and 1b only: must have progressed on at least one prior second generation ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide). * Part 2 only: must have progressed on one prior second generation ARPI (abiraterone, enzalutamide, darolutamide, or apalutamide). * Prior chemotherapy: * Part 1a dose escalation only: may have received ≤ 2 prior lines of chemotherapy in CRPC setting. Note: Prior chemotherapy is permitted in the HSPC setting. * Part 1b dose expansion/optimization only: may have received up to one prior line of chemotherapy in CRPC setting. Note: Prior chemotherapy is permitted in the HSPC setting. * Part 2 only: Participants must be taxane-naïve in mCRPC setting; prior chemotherapy permitted in HSPC setting only Key Exclusion Criteria: * Previous treatment with any PRC2 inhibitor, including but not limited to EZH2 inhibitors, EZH2/1 inhibitors, or embryonic ectoderm development (EED) inhibitors. * Previous treatment with a protein degrader compound that targets the AR. * Known hypersensitivity or contraindication to any of the study treatment components or its excipients or to drugs of similar chemical classes. * Treatment with any investigational agent within 28 days (or 5 half-lives, whichever is longer) prior to study entry. * Previous treatment with radioligand therapy in the mCRPC setting, except in Part 1a where participants may have received RLT in mCRPC setting. * Participants with evidence of mCRPC or biochemical recurrence / PSA only disease or asymptomatic prostate cancer without known metastatic disease and with no requirement for therapy and with normal PSA for ≥ 1 year prior to study entry. * Participants with a history of CNS metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purpose of maintaining neurologic integrity. Those with leptomeningeal disease are eligible if those areas have been treated, are stable, and no neurological impairment is present. For those with parenchymal CNS metastasis (or a history of CNS metastasis), baseline and subsequent radiological imaging must include evaluation of the brain with MRI (preferred) or CT with contrast. Other protocol-defined inclusion/exclusion criteria may apply.
Study sites (8)
CO
- Sarah Cannon Research Institute · Denver, CO 80218Alissa Snow · Study contact · 720-754-2610 · alissa.snow@sarahcannon.comGerald Falchook · Principal investigatorMore trials in Denver
FL
- Sarah Cannon Research Institute · Jacksonville, FL 32256Kandyce Trejo · Study contact · 941-377-9993 · kandyce.trejo@flcancer.orgManish Patel · Principal investigatorMore trials in Jacksonville
GA
- Emory University · Atlanta, GA 30329Wilena Session · Study contact · 404-778-1900 · wsessio@emory.eduJacqueline Brown · Principal investigatorMore trials in Atlanta
KS
- Wichita Urology Group PA · Wichita, KS 67226Tyler Gentry · Study contact · tgentry@wichitaurology.comTimothy Richardson · Principal investigatorMore trials in Wichita
MA
- Mass General Hospital · Boston, MA 02114Manda Ngin · Study contact · mngin@mgh.harvard.eduXin Gao · Principal investigatorMore trials in Boston
NC
- Duke University Medical Center · Durham, NC 27710Tykeytra Dale · Study contact · tykeytra.dale@duke.eduChristopher Hoimes · Principal investigatorMore trials in Durham
OH
- Cleveland Clinic Foundation · Cleveland, OH 44195Chandra Taylor · Study contact · 216-444-0441 · TAYLORC12@ccf.orgShilpa Gupta · Principal investigatorMore trials in Cleveland
WA
- Fred Hutchinson Cancer Research Center · Seattle, WA 98109-1024Ashley Gagnon · Study contact · 206-606-7486 · agagnon@fredhutch.orgMichael Schweizer · Principal investigatorMore trials in Seattle