A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive 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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-25

Study Completion Date

2023-07-12

Brief Summary

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This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy dose-escalation and dose expansion study of RO7444973.The aim of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RO7444973 in participants with unresectable and/or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive, solid tumors, carrying the HLA-A\*02:01 allele.

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Detailed Description

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Conditions

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Solid Tumors

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 I: Single Participant Cohort (SPC) Dose Escalation

In Part I, RO7444973 is administered intravenously (IV) every 3 weeks (Q3W) at a fixed dose in a single participant per dose level.

Group Type EXPERIMENTAL

RO7444973

Intervention Type DRUG

RO7444973 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective cohort.

Tocilizumab

Intervention Type DRUG

Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants \>/= 30 kg or at 12 mg/kg for participants \< 30 kg.

Part II: Multiple Participant Cohort (MPC) Dose Escalation

In Part II, RO7444973 is administered IV Q3W at a fixed dose in multiple participants per dose level. Step-up dosing may also be explored.

Group Type EXPERIMENTAL

RO7444973

Intervention Type DRUG

RO7444973 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective cohort.

Tocilizumab

Intervention Type DRUG

Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants \>/= 30 kg or at 12 mg/kg for participants \< 30 kg.

Part III: Recommended Phase 2 Dose (RP2D) Expansion

Based on emerging data from Part II, an RP2D and dosing regimen will be further investigated in Part III.

Group Type EXPERIMENTAL

RO7444973

Intervention Type DRUG

RO7444973 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective cohort.

Tocilizumab

Intervention Type DRUG

Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants \>/= 30 kg or at 12 mg/kg for participants \< 30 kg.

Interventions

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RO7444973

RO7444973 solution for infusion will be administered intravenously at a dose and per schedule as specified for the respective cohort.

Intervention Type DRUG

Tocilizumab

Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants \>/= 30 kg or at 12 mg/kg for participants \< 30 kg.

Intervention Type DRUG

Other Intervention Names

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Actemra, RoActemra

Eligibility Criteria

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Inclusion Criteria

* Unresectable and/or metastatic solid tumors that have received standard-of-care (SOC) therapies previously and have no other SOC options available
* Confirmed HLA-A\*02:01 haplotype
* Confirmed MAGE-A4 expression
* Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Life expectancy of \>/=12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
* Absence of rapid disease progression, threat to vital organs or non-irradiated lesions \>2 cm in diameter at critical sites
* No significant ongoing toxicity from prior anticancer treatment
* Adequate hematological function
* Adequate liver function
* Adequate renal function
* If applicable, willingness to use contraceptive measures.

Exclusion Criteria

* History or clinical evidence of CNS primary tumors or metastases
* Another invasive malignancy in the last 2 years
* Uncontrolled hypertension
* Significant cardiovascular disease
* Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic or other infection
* Current or past history of CNS disease
* Dementia or altered mental status that would prohibit informed consent
* Active auto-immune disease or flare within 6 months prior to start of study treatment
* Expected need for regular immunosuppressive therapy or with systemic corticosteroids
* Insufficient washout from prior anti-cancer therapy
* Prior treatment with a bispecific T-cell engaging or adoptive cell therapy.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No