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INBRX-106

Phase 2

Head and Neck Squamous Cell Carcinoma (HNSCC) | Small molecule | Oncology |Inhibrx Biosciences, Inc.|Last Updated: May 8, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment410

FDA Designations

No designations recorded

Clinical trial landscape

INBRX-106 · 1 trial · 1 indication

Phase 2 1
NCT06295731INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCCHead and Neck Squamous Cell Carcinoma (HNSCC)
ACTIVE NOT_RECRUITING410 Analytics
PHASE2ACTIVE NOT_RECRUITING
INBRX-106 in Combination With Pembrolizumab in First-line PD-L1 CPS≥20 HNSCC
Head and Neck Squamous Cell Carcinoma (HNSCC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Phase 2: Objective Response Rate (ORR)
up to 6 months

ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on 2 consecutive occasions ≥4 weeks apart, per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

Phase 3: Progression-Free Survival (PFS)
From randomization to first occurrence of progressive disease (PD) or death (up to 4 years)

PFS is defined as the time from randomization to first occurrence of PD, as determined by the Investigator according to RECIST v 1.1, or death from any cause (whichever occurs first).

Phase 3: Overall Survival (OS)
From randomization until death from any cause (up to 4 years)

OS is the time from randomization to death due to any cause

Secondary Endpoints

Phase 3: Objective Response Rate (ORR)
From randomization until treatment discontinuation (up to 2 years)
Duration of Response (DOR)
From the first occurrence of a documented objective response to PD or death (up to 4 years)
Clinical Benefit Rate (CBR)
From randomization until treatment discontinuation (up to 2 years)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
INBRX-106 plus pembrolizumabEXPERIMENTALParticipants will receive INBRX-106 plus pembrolizumab, both given by intravenous (IV) infusion every 3 weeks (QW3)
pembrolizumab monotherapy (+ placebo in phase 3 part)ACTIVE_COMPARATORParticipants will receive pembrolizumab (plus placebo in Phase 3), given by intravenous (IV) infusion every 3 weeks (QW3)

Interventions

NameTypeDescription
INBRX-106DRUGINBRX-106 by intravenous (IV) infusion, given every 3 weeks (QW3)
PembrolizumabDRUGPembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites87

Inclusion Criteria: * Has histologically or cytologically confirmed diagnosis of metastatic, recurrent head and neck squamous cell carcinoma (HNSCC) that is considered incurable by local therapies. * Has tumor PD-L1 expression of CPS ≥20. Tumor tissue must be provided for PD-L1 biomarker analysis. ...

Countries:United StatesAustraliaBelgiumBulgariaFranceItalyMalaysiaPolandRomaniaSouth KoreaSpainTaiwanUnited Kingdom
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Frequently asked questions about INBRX-106

What is INBRX-106 used for?

INBRX-106 is an investigational small molecule being developed for the treatment of Head and Neck Squamous Cell Carcinoma (HNSCC). It is currently in Phase 2 clinical development, evaluated in combination with pembrolizumab as a first-line therapy for patients with PD-L1 CPS≥20 HNSCC.

Who makes INBRX-106?

INBRX-106 is being developed by Inhibrx Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker INBX. The company is conducting a Phase 2 clinical trial of INBRX-106 in combination with pembrolizumab for the treatment of Head and Neck Squamous Cell Carcinoma.

What phase is INBRX-106 in?

INBRX-106 is in Phase 2 clinical development. It is being studied in an active, not recruiting clinical trial for Head and Neck Squamous Cell Carcinoma. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is INBRX-106 in?

INBRX-106 is being evaluated in one active Phase 2 clinical trial, NCT06295731. This randomized, double-blind, active-controlled study enrolls 410 participants with Head and Neck Squamous Cell Carcinoma and is testing INBRX-106 in combination with pembrolizumab as first-line therapy in patients with PD-L1 CPS≥20.

Is INBRX-106 a small molecule?

Yes, INBRX-106 is a small molecule therapeutic. It is being developed for the oncology indication of Head and Neck Squamous Cell Carcinoma and is currently in Phase 2 clinical trials.