Testing ROSE12 alone and with other cancer treatments for solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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

Where it's running

• University of Pennsylvania Perelman Center for Advanced Medicine
  Philadelphia, Pennsylvania, United States Recruiting
• Rhode Island Hospital
  Providence, Rhode Island, United States Recruiting
• SCRI Oncology Partners
  Nashville, Tennessee, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• NEXT Oncology
  Fairfax, Virginia, United States Recruiting
• Aichi Cancer Center
  Nagoya, Aichi-ken, Japan Recruiting

Study contacts

• Study coordinator: Clinical trials information
• Email: clinical-trials@chugai-pharm.co.jp
• Phone: only use Email

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.