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New treatment option for Solid Tumor
Official title A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT05907980
What this study is testing
What is ROSE12?
ROSE12 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase Ia/Ib open-label, dose-escalation study to evaluate the safety and pharmacokinetics of ROSE12 as a single agent and in combination with other anti-tumor agents in patients with locally advanced or metastatic solid tumors. The study will consist of three parts: a dose-escalation part, a biopsy part (the part to evaluate biomarkers), and an expansion part.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>= 18 years at time of signing informed consent form (ICF)
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
- Adequate hematologic and end-organ function
- Life expectancy \>= 12 weeks
- Patients with histologic documentation of locally advanced, or metastatic solid tumor
You likely can't join if
- Clinically significant cardiovascular or liver disease
- Treatment with investigational therapy and anti-cancer therapy within 28 days prior to initiation of study drug
- Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than asymptomatic elevation of serum amylase...
- All imAEs from prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy, stable vitiligo or stable alopecia) that have...
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with...
- Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
See the full eligibility criteria
- Age \>= 18 years at time of signing informed consent form (ICF)
- Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1
- Adequate hematologic and end-organ function
- Life expectancy \>= 12 weeks
- Patients with histologic documentation of locally advanced, or metastatic solid tumor
- [Dose-escalation Parts and Biopsy Parts]Refractory or resistant to standard therapies or standard therapies are not available
- [Dose-escalation Parts and Expansion Part] Patients with confirmed availability of fresh tumor or representative tumor specimens
- [Biopsy Parts] Patients with accessible lesion(s)
- Clinically significant cardiovascular or liver disease
- Treatment with investigational therapy and anti-cancer therapy within 28 days prior to initiation of study drug
- Any history of an immune-mediated Grade 4 adverse event attributed to prior cancer immunotherapy (other than asymptomatic elevation of serum amylase or lipase).
- All imAEs from prior cancer immunotherapy (other than endocrinopathy managed with replacement therapy, stable vitiligo or stable alopecia) that have not resolved completely to baseline.
- Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy
- Primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Active or history of clinically significant autoimmune disease
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins. [Expansion Part]
- Prior treatment with investigational product which has MoA of Treg depletion
- Malignancies other than disease under study within 5 years prior to Cycle 1 Day 1
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Kashiwa-shi, Chiba, Japan
- Chuo-ku, Tokyo, Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States; Fairfax, Virginia, United States; Kashiwa-shi, Chiba, Japan; Chuo-ku, Tokyo, Japan. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.