Testing ROSE12 alone and with other cancer treatments for solid tumors
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
PHASE1 · Chugai Pharmaceutical · NCT05907980
This study is testing a new cancer treatment called ROSE12, both on its own and with other therapies, to see how safe it is and how well it works for people with advanced solid tumors.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 219 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chugai Pharmaceutical (industry) |
| Drugs / interventions | immunotherapy |
| Locations | 4 sites (Houston, Texas and 3 other locations) |
| Trial ID | NCT05907980 on ClinicalTrials.gov |
What this trial studies
This Phase I open-label study evaluates the safety and pharmacokinetics of ROSE12, both as a standalone treatment and in combination with other anti-tumor agents, in patients with locally advanced or metastatic solid tumors. The study is structured in three parts: a dose-escalation phase to determine the optimal dosage, a biopsy phase to assess biomarkers, and an expansion phase to further evaluate the treatment's efficacy. Participants will be closely monitored for safety and response to the treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with locally advanced or metastatic solid tumors that have not responded to standard treatments.
Not a fit: Patients with significant cardiovascular or liver disease or those who have experienced severe immune-mediated adverse events from previous cancer therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with solid tumors that are resistant to standard therapies.
How similar studies have performed: Other studies have shown promise with similar approaches in targeting solid tumors, suggesting potential for success in this novel treatment strategy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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) Exclusion Criteria: * 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
Where this trial is running
Houston, Texas and 3 other locations
- MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
- NEXT Oncology — Fairfax, Virginia, United States (RECRUITING)
- National Cancer Center Hospital East — Kashiwa-shi, Chiba, Japan (RECRUITING)
- National Cancer Center Hospital — Chuo-ku, Tokyo, Japan (RECRUITING)
Study contacts
- Study coordinator: Clinical trials information
- Email: clinical-trials@chugai-pharm.co.jp
- Phone: only use Email
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumor