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

Recruiting Phase 1 Interventional Study
Solid Tumor
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
209 (estimated)
Sponsor
Chugai Pharmaceutical · Industry
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About This Trial

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.

Trial Locations
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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-esc…
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clinical-trials@chugai-pharm.co.jp

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