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Domvanalimab

Phase 2

Advanced Non-Small Cell Lung Cancer | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Sep 3, 2026

Target and mechanism

Molecular targetTIGIT
Target classInhibitor
ModalitySmall molecule

Also known as Domvanalimab (DOM)

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment400

FDA Designations

No designations recorded

Clinical trial landscape

Domvanalimab · 2 trials · 2 indications

Phase 2 2
NCT06727565Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01Head and Neck Squamous Cell Carcinoma
ACTIVE NOT_RECRUITING39 Analytics
NCT05676931Study With Various Immunotherapy Treatments in Participants With Lung CancerAdvanced Non-Small Cell Lung Cancer
ACTIVE NOT_RECRUITING400 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status; Substudy-01
Head and Neck Squamous Cell CarcinomaUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
Study With Various Immunotherapy Treatments in Participants With Lung Cancer
Advanced Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective response rate (ORR)
Up to 36 months

ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using investigator assessments.

Progression-free survival (PFS)
Up to 36 months

PFS is defined as the time from the date of randomization until the first date of documented progressive disease (PD) or death from any cause, whichever occurs first, as measured by RECIST v1.1 using investigator assessments.

Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
Up to 58 months
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Up to 58 months

Secondary Endpoints

Duration of Response (DOR)
Up to 36 months
Progression-Free Survival at 6 Months (PFS6)
Up to 6 months
Overall Survival (OS)
Up to 36 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment Group A: Domvanalimab (DOM) + Zimberelimab (ZIM) + Platinum-based ChemotherapyEXPERIMENTALParticipants will receive DOM + ZIM + platinum-based chemotherapy (paclitaxel + carboplatin).
Treatment Group B: Zimberelimab (ZIM) + Platinum-based ChemotherapyEXPERIMENTALParticipants will receive ZIM + platinum-based chemotherapy (paclitaxel + carboplatin).
A1: Domvanalimab + ZimberelimabEXPERIMENTALDomvanalimab and Zimberelimab, both administered by IV infusion
A2: Domvanalimab + ZimberelimabEXPERIMENTALDomvanalimab and Zimberelimab, both administered by IV infusion
A3: Quemliclustat + ZimberelimabEXPERIMENTALQuemliclustat and Zimberelimab, both administered by IV infusion
B1: Quemliclustat + Zimberelimab + Platinum Doublet ChemotherapyEXPERIMENTALQuemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
B2: Domvanalimab + Zimberelimab + Platinum Doublet ChemotherapyEXPERIMENTALDomvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet ChemotherapyEXPERIMENTALDomvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
B4: Domvanalimab + Zimberelimab + Platinum Doublet ChemotherapyEXPERIMENTALDomvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
B5: Domvanalimab + Zimberelimab + Platinum Doublet ChemotherapyEXPERIMENTALDomvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion
C1: Quemliclustat + Zimberelimab + DocetaxelEXPERIMENTALQuemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion
C2: Domvanalimab + Zimberelimab + DocetaxelEXPERIMENTALDomvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion

Interventions

NameTypeDescription
DomvanalimabDRUGAdministered intravenously
ZimberelimabDRUGAdministered intravenously
PaclitaxelDRUGAdministered intravenously
CarboplatinDRUGAdministered intravenously
QuemliclustatDRUGAdministered as specified in the treatment arm
DocetaxelDRUGAdministered as specified in the treatment arm
Platinum-Based DoubletDRUGAdministered as specified in the treatment arm
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites23

Key Inclusion Criteria: * Histologically or cytologically confirmed r/m squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies. * No prior systemic therapy for r/m HNSCC. Individuals who had disease progression or recurrence m...

Countries:United StatesAustraliaChinaFranceItalyMalaysiaSpainTaiwanUnited KingdomGeorgiaPolandSouth Korea
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Competitive Landscape -Non-Small Cell Lung Cancer 387 trials (matched to "Advanced Non-Small Cell Lung Cancer")

Recent Changes (Last 90 Days)

HIGHSep 3, 2026NCT06727565Enrollment: 100 → 39
HIGHSep 3, 2026NCT06727565Enrollment: 100 → 39

Frequently asked questions about Domvanalimab

What is Domvanalimab used for?

Domvanalimab is an investigational small molecule being studied for the treatment of Head and Neck Squamous Cell Carcinoma and Advanced Non-Small Cell Lung Cancer. It is currently in Phase 2 clinical development and has not been approved by the FDA.

What does Domvanalimab target?

Domvanalimab targets TIGIT, an inhibitory receptor, and acts as a TIGIT inhibitor. By blocking TIGIT, it is designed to enhance the immune system's ability to fight cancer cells. This mechanism is being evaluated in ongoing clinical trials for solid tumors.

Who makes Domvanalimab?

Domvanalimab is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting clinical trials to evaluate the drug's safety and efficacy in oncology indications.

What phase is Domvanalimab in?

Domvanalimab is currently in Phase 2 clinical trials. It is an investigational drug, meaning it has not yet received regulatory approval. The ongoing studies are assessing its use in Advanced Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma.

What clinical trials is Domvanalimab in?

Domvanalimab is being studied in two active Phase 2 trials. NCT05676931 enrolls 400 participants with Advanced Non-Small Cell Lung Cancer across multiple countries. NCT06727565 enrolls 39 participants with Head and Neck Squamous Cell Carcinoma. Both trials are active but not recruiting.

Is Domvanalimab the same as DOM?

Yes, Domvanalimab is also known as DOM. This abbreviation is used in clinical and research contexts to refer to the same investigational drug. Both names refer to the TIGIT inhibitor being developed by Gilead Sciences.