Recruiting
Phase 1

ROSE12

Sponsor:

Chugai Pharmaceutical

Code:

NCT05907980

Conditions

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ROSE12

Atezolizumab

Pembrolizumab

Study Details

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.

Conditions

Solid Tumor

Study ID

NCT05907980

Start date

May 24, 2023

Status verified date

Jul, 2026

Completion date

Oct 31, 2027

Anticipated

Primary completion date

Oct 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

  • 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

Study Design

Enrollment

209 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Dose-escalation part of Phase Ia

Patients will receive ROSE12 as a IV infusion at escalated doses.

experimental: Part B: Biopsy part of Phase Ia

Serial biopsy will be conducted with patients who will receive ROSE12 as a IV infusion at escalated doses.

experimental: Part C: Dose-escalation part of Phase Ib

Patients will receive ROSE12 and atezolizumab as a IV infusion at escalated doses.

experimental: Part D: Biopsy part of Phase Ib

Serial biopsy will be conducted with patients who will receive ROSE12 and atezolizumab as a IV infusion at escalated doses.

experimental: Part E: Expansion part of Phase Ib in patients with selected solid tumors

Patients will receive ROSE12 and atezolizumab as a IV infusion at the recommended dose.

experimental: Part F: Expansion part of Phase Ib in patients with selected solid tumors

Patients will receive ROSE12 and pembrolizumab as a IV infusion at the recommended dose.

Interventions

ROSE12

ROSE12 as a IV infusion

Atezolizumab

Atezolizumab as a IV infusion

Pembrolizumab

Pembrolizumab as a IV infusion

Primary outcome measure

  • 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) [ Time Frame: From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days) ]
  • 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) [ Time Frame: From screening until study completion, treatment discontinuation or post-treatment follow up, assessed up to the end of the study (approximate 43 months) ]
  • 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) [ Time Frame: 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 for PK profile when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts) [ Time Frame: 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 for PK profile when administered as a single agent and in combination with atezolizumab or pembrolizumab (All Parts) [ Time Frame: 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) ]
  • Preliminary anti-tumor activity of ROSE12 when administered in combination with atezolizumab or pembrolizumab (Part E and F) [ Time Frame: From screening until study completion or treatment discontinuation, assessed up to the end of the study (approximate 43 months) ]

Central Contacts and Locations

Central contacts

Clinical trials information

only use Emailclinical-trials@chugai-pharm.co.jp

Locations

University of Pennsylvania Perelman Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

NEXT Oncology

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Chugai Pharmaceutical

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Chugai Pharmaceutical on 2026-07-28.