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NCT05907980 | RECRUITING | Solid Tumor

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

Chugai Pharmaceutical

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.

Condition or disease

Solid Tumor

Intervention/treatment

ROSE12

Atezolizumab

Phase

PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 219 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-05-24
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors

Location Details

NCT05907980

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Locations

RECRUITING

United States, Texas

MD Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Virginia

NEXT Oncology

Fairfax, Virginia, United States, 22031

RECRUITING

Japan, Chiba

National Cancer Center Hospital East

Mr. Kashiwa, Chiba, Japan, 277-8577

RECRUITING

Japan, Tokyo

National Cancer Center Hospital

C-Cry, Tokyo, Japan, 104-0045