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

Chugai Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor

Treatments: Drug: Atezolizumab; Drug: ROSE12

Study type: Interventional

Funder types: Industry

Identifiers

NCT05907980

RSE101CT

Details and patient eligibility

About

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.

Enrollment: 219 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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)

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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219 participants in 5 patient groups

Part A: Dose-escalation part of Phase Ia

Experimental group

Description:

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

Treatment:

Drug: ROSE12

Part B: Biopsy part of Phase Ia

Experimental group

Description:

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

Treatment:

Drug: ROSE12

Part C: Dose-escalation part of Phase Ib

Experimental group

Description:

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

Treatment:

Drug: ROSE12

Drug: Atezolizumab

Part D: Biopsy part of Phase Ib

Experimental group

Description:

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

Treatment:

Drug: ROSE12

Drug: Atezolizumab

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

Experimental group

Description:

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

Treatment:

Drug: ROSE12

Drug: Atezolizumab