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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-24

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: Dose-escalation part of Phase Ia

Patients will receive ROSE12 as a IV infusion at escalated doses.

Group Type EXPERIMENTAL

ROSE12

Intervention Type DRUG

ROSE12 as a IV infusion

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.

Group Type EXPERIMENTAL

ROSE12

Intervention Type DRUG

ROSE12 as a IV infusion

Part C: Dose-escalation part of Phase Ib

Patients will receive ROSE12 and atezolizumab as a IV infusion at escalated doses.

Group Type EXPERIMENTAL

ROSE12

Intervention Type DRUG

ROSE12 as a IV infusion

Atezolizumab

Intervention Type DRUG

Atezolizumab as a IV infusion

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.

Group Type EXPERIMENTAL

ROSE12

Intervention Type DRUG

ROSE12 as a IV infusion

Atezolizumab

Intervention Type DRUG

Atezolizumab as a IV infusion

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.

Group Type EXPERIMENTAL

ROSE12

Intervention Type DRUG

ROSE12 as a IV infusion

Atezolizumab

Intervention Type DRUG

Atezolizumab as a IV infusion

Interventions

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ROSE12

ROSE12 as a IV infusion

Intervention Type DRUG

Atezolizumab

Atezolizumab as a IV infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No