NCT05907980 A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors
| NCT ID | NCT05907980 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Chugai Pharmaceutical |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 209 participants |
| Start Date | 2023-05-24 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 209 participants in total. It began in 2023-05-24 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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) * \[Expansion Parts\] Patients with ICI (immune checkpoint inhibitor)-refractory 2L-3L NSCLC (non-small-cell lung cancer) and 3L+ CRC (colorectal cancer) 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
Contact & Investigator
Sponsor Chugai Pharmaceutical Co.Ltd
STUDY DIRECTOR
clinical-trials@chugai-pharm.co.jp
Frequently Asked Questions
Who can join the NCT05907980 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05907980 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05907980 currently recruiting?
Yes, NCT05907980 is actively recruiting participants. Contact the research team at clinical-trials@chugai-pharm.co.jp for enrollment information.
Where is the NCT05907980 trial being conducted?
This trial is being conducted at Philadelphia, United States, Providence, United States, Nashville, United States, Houston, United States and 10 additional locations.
Who is sponsoring the NCT05907980 clinical trial?
NCT05907980 is sponsored by Chugai Pharmaceutical. The principal investigator is Sponsor Chugai Pharmaceutical Co.Ltd at clinical-trials@chugai-pharm.co.jp. The trial plans to enroll 209 participants.