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Runimotamab

Phase 1

Solid Tumors | Small molecule | Oncology |Roche Holding AG|Last Updated: Aug 26, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment123

FDA Designations

No designations recorded

Clinical trial landscape

Runimotamab · 1 trial · 1 indication

Phase 1 1
NCT03448042A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing CancersSolid Tumors
ACTIVE NOT_RECRUITING123 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants with Adverse Events
From baseline through end of study (approximately 78 months)

Secondary Endpoints

Serum Concentration of Runimotamab
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Area Under the Serum Concentration vs. Time Curve (AUC) of Runimotamab
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
Maximum Observed Serum Concentration (Cmax) of Runimotamab
At predefined intervals from Cycle 1, Day 1 (approximately 1 year)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALParticipants will be assigned sequentially to escalating doses of runimotamab up to the maximum tolerated dose (MTD).
Dose ExpansionEXPERIMENTALParticipants will receive runimotamab based on the MTD or maximum allowed dose (MAD) identified during dose escalation.

Interventions

NameTypeDescription
RunimotamabDRUGRunimotamab will be administered via IV infusion until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
TrastuzumabDRUGTrastuzumab will be administered via IV infusion
TocilizumabDRUGParticipants will receive IV tocilizumab if needed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Life expectancy of at least 12 weeks * Adequate hematologic and end-organ function * Acute, clinically significant treatment-related toxicity from prior therapy must have resolved to Grade \</=1 prior to s...

Countries:United StatesAustraliaBelgiumCanadaDenmarkFranceItalyNetherlandsSingaporeSouth KoreaSpainTaiwanUnited Kingdom
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Recent Changes (Last 90 Days)

LOWAug 26, 2026NCT03448042primaryCompletionDate: changed
LOWAug 26, 2026NCT03448042primaryCompletionDate: changed

Frequently asked questions about Runimotamab

What is Runimotamab used for?

Runimotamab is an investigational small molecule being studied for the treatment of solid tumors. It is currently in Phase 1 clinical development for patients with locally advanced or metastatic HER2-expressing cancers. The drug is being evaluated in a clinical trial to assess its safety and efficacy in this patient population.

What does Runimotamab target?

Runimotamab is a monoclonal antibody (a -mab) that targets HER2-expressing cancers. It is being developed to treat solid tumors that express the HER2 receptor. The drug is designed to bind to HER2 on cancer cells, potentially interfering with tumor growth and progression.

Who makes Runimotamab?

Runimotamab is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical trials to evaluate the drug's safety and efficacy in patients with HER2-expressing solid tumors. The company is responsible for the drug's research, development, and potential future commercialization.

What phase is Runimotamab in?

Runimotamab is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the drug's safety, tolerability, and preliminary efficacy in patients with locally advanced or metastatic HER2-expressing cancers.

What clinical trials is Runimotamab in?

Runimotamab is being studied in a Phase 1 clinical trial with the identifier NCT03448042. This trial is titled 'A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers' and is currently active but not recruiting. The trial has enrolled 123 participants across multiple countries, including the United States, Australia, and several European and Asian nations.

Is Runimotamab the same as any other drug?

Runimotamab is a unique investigational drug and no alternative names have been reported. It is being developed by Roche as a monoclonal antibody targeting HER2-expressing solid tumors. As a Phase 1 candidate, it is distinct from other HER2-targeted therapies currently on the market or in development.