NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

RecruitingPhase 1

Sponsor: Chugai Pharmaceutical

Conditions: Solid Tumor

Interventions: ROSE12, Atezolizumab, Pembrolizumab

Countries: United States, Japan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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)
* \[Expansion Parts\] 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

Locations (14)

Philadelphia, Pennsylvania, United States
Providence, Rhode Island, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Fairfax, Virginia, United States
Nagoya, Aichi-ken, Japan
Kashiwa-shi, Chiba, Japan
Yokohama, Kanagawa, Japan
Hirakata-shi, Osaka, Japan
Osaka, Osaka, Japan
Sakai-shi, Osaka, Japan
Nagaizumi-chō, Shizuoka, Japan
Chuo-ku, Tokyo, Japan
Koto-Ku, Tokyo, Japan