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

Part of paid clinical trials in Houston, Texas.

Sponsor
Chugai Pharmaceutical
Study ID
NCT05907980
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ROSE12 — DRUG
    ROSE12 as a IV infusion
  • Atezolizumab — DRUG
    Atezolizumab as a IV infusion

Study Details

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.

Key Dates

Start date
May 24, 2023
Status verified
Mar 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
219 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Dose-escalation part of Phase Ia
    Patients will receive ROSE12 as a IV infusion at escalated doses.
  • Experimental: Part B: Biopsy part of Phase Ia
    Serial biopsy will be conducted with patients who will receive ROSE12 as a IV infusion at escalated doses.
  • Experimental: Part C: Dose-escalation part of Phase Ib
    Patients will receive ROSE12 and atezolizumab as a IV infusion at escalated doses.
  • Experimental: Part D: Biopsy part of Phase Ib
    Serial biopsy will be conducted with patients who will receive ROSE12 and atezolizumab as a IV infusion at escalated doses.
  • Experimental: Part E: Expansion part of Phase Ib in patients with selected solid tumors
    Patients will receive ROSE12 and atezolizumab as a IV infusion at the recommended dose.

Primary Outcome Measure

The maximum tolerated dose (MTD) and the recommended dose (RD) of ROSE12 when administered as a single agent and in combination with atezolizumab (Part A and C) [ Time Frame: From Cycle 1 Day 1 until Cycle 1 Day 21 (Cycle 1 is 21 days) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030-
NEXT OncologyFairfaxVirginia22031-

Find similar trials in Houston, TX

By research site
MD Anderson Cancer Center· Houston, TXNEXT Oncology· Fairfax, VA

Related Studies