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RO7247669

Phase 2

Melanoma | Small molecule | Oncology |Roche Holding AG|Last Updated: Jun 16, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment93

FDA Designations

No designations recorded

Clinical trial landscape

RO7247669 · 2 trials · 5 indications

Phase 2 1Phase 1 1
NCT05419388A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic MelanomaMelanoma
COMPLETED93 Analytics
PHASE2COMPLETED
A Study of Multiple Doses of RO7247669 in Participants With Previously Untreated Unresectable or Metastatic Melanoma
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-free survival (PFS)
From randomization to the first occurrence of progression or death during the treatment period or within 60 days of the last tumor assessment after treatment discontinuation from any cause, whichever occurs first (up to 25 months)
Part A: Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Days 1-21 (Q2W dosing) or Days 1-28 (Q3W dosing) of Cycle 1
Part A: Percentage of Participants with Adverse Events
Baseline through the end of study (up to 24 months)
Part B: Objective Response Rate (ORR)
Up to 24 months
Part B: Disease Control Rate (DCR), Defined as ORR + Stable Disease Rate (SDR)
Up to 24 months
Part B: Duration of Response (DOR)
Up to 24 months
Part B: Progression-free Survival (PFS), Defined as the Time from the First Study Treatment to the First Occurrence of Progression per Investigator Assessment or Death from any Cause, Whichever Occurs First
Up to 24 months

Secondary Endpoints

Percentage of Participants with Adverse Events
Up to 25 months
Objective response rate (ORR)
Up to 25 months
Disease control rate (DCR)
Up to 25 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low dose every three weeks (Q3W)EXPERIMENTALParticipants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
High dose Q3WEXPERIMENTALParticipants will receive RO7247669 Q3W until loss of clinical benefit, unacceptable toxicity, or a maximum of 24 months.
Part A: Single-Agent Dose EscalationEXPERIMENTALParticipants will receive RO7247669 every 2 weeks (Q2W) or every 3 weeks (Q3W) up to the maximum tolerated dose (MTD) until disease progression, unacceptable drug toxicity, or withdrawal of consent, for up to 24 months.
Part B: Tumor Specific Expansion CohortsEXPERIMENTALParticipants with selected solid tumor indications will receive RO7247669 at a dose derived from Part A until disease progression, unacceptable drug toxicity, or withdrawal of consent, for up to 24 months.

Interventions

NameTypeDescription
RO7247669DRUGParticipants will receive intravenous (IV) RO7247669 Q3W
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites22

Inclusion Criteria: * Histologically confirmed unresectable or metastatic melanoma, per the American Joint Committee on Cancer (AJCC) staging system (unresectable Stage III or Stage IV) * Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Eas...

Countries:AustraliaBrazilCanadaCzechiaGreeceNew ZealandPolandSlovakiaSpainTurkey (Türkiye)DenmarkGeorgiaIsraelMexicoSingaporeSouth KoreaUnited Kingdom
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Frequently asked questions about RO7247669

What is RO7247669 used for?

RO7247669 is an investigational bispecific antibody being studied for the treatment of solid tumors and melanoma. It is currently in clinical development for advanced or metastatic solid tumors, including non-small cell lung cancer and esophageal squamous cell carcinoma, as well as for previously untreated unresectable or metastatic melanoma.

What does RO7247669 target?

RO7247669 targets PD-1 and LAG-3, as it is a PD1-LAG3 bispecific antibody. By binding to both of these immune checkpoint proteins, it is designed to modulate the immune response against tumor cells.

Who makes RO7247669?

RO7247669 is being developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy in oncology indications.

What phase is RO7247669 in?

RO7247669 is in Phase 2 clinical development. It has completed a Phase 1 dose escalation study and a Phase 2 study in melanoma. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is RO7247669 in?

RO7247669 has been studied in two clinical trials. NCT04140500 is a Phase 1 dose escalation study in patients with advanced or metastatic solid tumors. NCT05419388 is a Phase 2 study in participants with previously untreated unresectable or metastatic melanoma.

Is RO7247669 the same as a PD1-LAG3 bispecific antibody?

Yes, RO7247669 is a PD1-LAG3 bispecific antibody. It is designed to target both PD-1 and LAG-3, and it is being investigated for its potential role in treating solid tumors and melanoma.