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

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

NCT ID: NCT05907980

Condition: Solid Tumor

Conditions: Official terms:
Neoplasms
Atezolizumab

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ROSE12
Description: ROSE12 as a IV infusion
Arm group label: Part A: Dose-escalation part of Phase Ia
Arm group label: Part B: Biopsy part of Phase Ia
Arm group label: Part C: Dose-escalation part of Phase Ib
Arm group label: Part D: Biopsy part of Phase Ib
Arm group label: Part E: Expansion part of Phase Ib in patients with selected solid tumors

Intervention type: Drug
Intervention name: Atezolizumab
Description: Atezolizumab as a IV infusion
Arm group label: Part C: Dose-escalation part of Phase Ib
Arm group label: Part D: Biopsy part of Phase Ib
Arm group label: Part E: Expansion part of Phase Ib in patients with selected solid tumors

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.

Criteria for eligibility:
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 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Facility:
Name: NEXT Oncology

Address:
City: Fairfax
Zip: 22031
Country: United States

Status: Recruiting

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa-shi
Zip: 277-8577
Country: Japan

Status: Recruiting

Facility:
Name: National Cancer Center Hospital

Address:
City: Chuo-ku
Zip: 104-0045
Country: Japan

Status: Recruiting

Start date: May 24, 2023

Completion date: December 31, 2026

Lead sponsor:
Agency: Chugai Pharmaceutical
Agency class: Industry

Source: Chugai Pharmaceutical

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05907980