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

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chugai Pharmaceutical
• Treatments: Atezolizumab

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 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