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Phase I Study of ROSE12 for Solid Tumors

This study is testing a new drug called ROSE12, by itself and with other anti-cancer drugs like atezolizumab and pembrolizumab, for people with advanced solid tumors. The main goals are to find the safest and most effective dose of ROSE12, and to understand its side effects and how it moves through the body. You might be able to join if you are at least 18 years old, have a solid tumor that has not responded to standard treatments, and are generally healthy enough for the study. This study is in an early stage (Phase I), meaning it's focused on safety and dosage.

Study design
This is an open-label, dose-escalation study, meaning both you and your doctors will know which treatment you are receiving. It plans to enroll up to 209 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed from screening until the end of the study, which is approximately 43 months after treatment starts.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05907980

A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Chugai Pharmaceutical
~209 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:ROSE12AtezolizumabPembrolizumab

At a glance

Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The maximum tolerated dose (MTD) and the recommended dose (RD) of ROSE12 when administered as a single agent and in combination with atezolizumab (Part A and C)
Measured over From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days)
+5 more outcomes measured

Conditions

Solid Tumor

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Where it's being run

14 sites across 11 states
Osaka3
Tokyo2
Pennsylvania1
Rhode Island1
Tennessee1
Texas1
Virginia1
Aichi-ken1

Study leadership

Who to contact

Clinical trials information
[email protected]
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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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.
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

What this trial measures

  • The maximum tolerated dose (MTD) and the recommended dose (RD) of ROSE12 when administered as a single agent and in combination with atezolizumab (Part A and C)From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days)

    Incidence and nature of dose-limiting toxicities (DLTs)

  • Safety (All Parts) and tolerability (Part A, B, C and D) of ROSE12 when administered as a single agent and in combination with atezolizumab or pembrolizumab (Adverse Events)From screening until study completion, treatment discontinuation or post-treatment follow up, assessed up to the end of the study (approximate 43 months)

    Incidence, nature, and severity of adverse events graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0

  • The maximum serum concentration (Cmax) of ROSE12 for PK profile when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

    The maximum serum concentration (Cmax) of ROSE12

  • The minimum serum concentration (Cmin) of ROSE12 for PK profile when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

    The minimum serum concentration (Cmin) of ROSE12

  • The area under the concentration time-curve (AUC) of ROSE12 for PK profile when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts)From Cycle 1 Day 1 (Cycle 1 is 21 days) until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

    The area under the concentration time-curve (AUC) of ROSE12

  • Preliminary anti-tumor activity of ROSE12 when administered in combination with atezolizumab or pembrolizumab (Part E and F)From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months)

    Objective response rate (ORR), defined as the proportion of patients with an objective response (complete response \[CR\] or partial response \[PR\]) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to the Response Evaluation Criteria in Solid Tumors version 1.1