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RO7300490

Phase 1

Solid Tumors | Small molecule | Oncology |Roche Holding AG|Last Updated: Feb 5, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

RO7300490 · 1 trial · 1 indication

Phase 1 1
NCT04857138A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid TumorsSolid Tumors
COMPLETED80 Analytics
PHASE1COMPLETED
A Study to Evaluate Safety, Pharmacokinetics and Anti-Tumor Activity of RO7300490, as Single Agent or in Combination With Atezolizumab in Participants With Advanced Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants with Adverse Events (AEs) (Parts 1 and 2)
Up to 36 months
Percentage of Participants with Dose-Limiting Toxicities (DLTs) (Parts 1 and 2)
Up to 36 months
Objective Response Rate (ORR) (Part 3)
Up to 48 months

Secondary Endpoints

Area Under The Curve (AUC) of RO7300490 (Parts 1, 2 and 3)
Up to 48 months
Minimum Concentration (Cmin) of RO7300490 (Parts 1, 2 and 3)
Up to 48 months
Maximum Concentration (Cmax) of RO7300490 (Parts 1, 2 and 3)
Up to 48 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Dose Escalation (RO7300490 Monotherapy)EXPERIMENTALParticipants will receive escalating doses of RO7300490 intravenously (IV) as a single agent for up to 24 months maximum or until progressive disease, unacceptable toxicities, death, or withdrawal of consent.
Part 2: Dose Escalation (RO7300490/atezolizumab combination therapy)EXPERIMENTALParticipants will receive escalating doses of RO7300490 in combination with a fixed dose of atezolizumab IV (as per label) for up to 24 months maximum or until progressive disease, unacceptable toxicities, death, or withdrawal of consent.
Part 3: Dose Expansion (Disease-specific Expansion(s))EXPERIMENTALParticipants with selected types of advanced and/or metastatic tumors will receive the maximum tolerated dose (MTD) or recommended dose for expansion (RDE) (determined from Parts 1 and 2) of RO7300490 in combination with a fixed dose of atezolizumab IV (as per label). Treatment will be administered for up to 24 months maximum or until progressive disease, unacceptable toxicities, death, or withdrawal of consent.

Interventions

NameTypeDescription
RO7300490DRUGParticipants will receive RO7300490, as described in the Arm Descriptions.
AtezolizumabDRUGParticipants will receive Atezolizumab, as described in the Arm Descriptions.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Life expectancy of \>= 12 weeks. * Histologically confirmed diagnosis of locally advanced and/or metastatic solid tumors that are not amenable to standard therapy. * Radiologically measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * A...

Countries:DenmarkFranceSouth KoreaSpainUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Frequently asked questions about RO7300490

What is RO7300490 used for?

RO7300490 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is being evaluated as a single agent and in combination with atezolizumab in participants with advanced solid tumors.

Who makes RO7300490?

RO7300490 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research to evaluate the safety, pharmacokinetics, and anti-tumor activity of this investigational drug.

What phase is RO7300490 in?

RO7300490 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed to evaluate its safety and tolerability.

What clinical trials is RO7300490 in?

RO7300490 has been studied in one clinical trial, identified as NCT04857138. This Phase 1 study evaluated the drug as a single agent or in combination with atezolizumab in participants with advanced solid tumors. The trial has been completed.

Is RO7300490 the same as atezolizumab?

No, RO7300490 is not the same as atezolizumab. RO7300490 is an investigational small molecule, while atezolizumab is a separate drug that was used in combination with RO7300490 in the clinical trial. They are distinct therapeutic agents.