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AzTrials

Head and Neck Squamous Cell Carcinoma (HNSCC)Phase 2/3HexAgon-HNNCT06295731

Ordastobart (INBRX-106) Add-on to Pembrolizumab in 1L HPV+ PD-L1+ R/M OPSCC (HexAgon-HN)

A Phase 2/3 study testing INBRX-106 and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and HPV Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC), run by Inhibrx Biosciences, Inc at 89 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody ordastobart (INBRX-106) combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with recurrent or metastatic… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
INBRX-106 and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
89 sitesin 13 countries
Study dates
14 May 2024to May 2031
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has histologically or cytologically confirmed diagnosis of recurrent/metastatic oropharyngeal squamous cell carcinoma (OPSCC) considered incurable by local therapies.
  • Has tumor PD-L1 expression with a combined proportion score (CPS) ≥1 by central testing.
  • HPV-positive tumor status as assessed locally by p16 immunohistochemistry (IHC).
  • Has measurable disease per RECIST 1.1 guidelines.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Who cannot join

  • Has primary tumor site (any histology) of any other location than oropharynx.
  • Has received prior systemic therapy (eg, prior chemo-, immune-, or biologic therapy) for R/M HNSCC.
  • Prior systemic therapy completed >6 months prior to signing informed consent is allowed if given as part of multimodal treatment for locoregionally advanced disease with curative intent, and no PD/recurrence occurred within 6 months of its completion. Prior systemic immunotherapy with curative intent, including but not limited to anti-PD-(L)1 agents, is allowed if PD/recurrence occurred ≥12 months after its completion.
  • Has clinically active central nervous system metastases and/or carcinomatous meningitis.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
  • Rapidly progressing disease.
  • Active or high risk of tumor-associated bleeding.
  • Current or history of immune-related disease that required systemic treatment in past 2 years, except for replacement therapy.

Trial locations and contacts

89 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Study Director - Inhibrx contact

858-500-7833

clinicaltrials@inhibrx.com

89 sites in 13 countries

United States26 sites, 19 recruiting

  • Intermountain Health, St. Vincent Regional Hospital, Cancer Centers of Montana

    Billings, Montana, 59102

    406-238-6963

    Patrick Cobb, MD

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Active, not recruiting

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599-7305

    Jonathan Jackson, 919-966-4432, jtjacks@email.unc.edu

    Helan Mathai, 919-966-4432, helan@email.unc.edu

    Recruiting

  • University of Illinois Cancer Center

    Chicago, Illinois, 60612

    Annette Kinsella, 312-996-6275, annettek@uic.edu

    Ameen Salahudeen, MD, PhD

    Recruiting

  • CHRISTUS Spohn Cancer Center

    Corpus Christi, Texas, 78404

    361-861-9721

    Swetha Panati, MD

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    313-576-9811

    Ammar Sukari, MD

    Recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    800-826-4673

    Victoria M Villaflor, MD

    Recruiting

  • University of Florida UF Health Cancer Center

    Gainesville, Florida, 32608

    Active, not recruiting

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

    Ann Lovelace, ann.lovelace@usoncology.com

    Lindsay Kondo, 7029523406, lindsay.kondo@usoncology.com

    Recruiting

  • Los Angeles Cancer Network (LACN)

    Los Angeles, California, 91204

    213-977-1214

    Sungwon Rachel Kyung, MD

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

    502-629-3569

    Jaspreet Grewal, MD

    Recruiting

  • The Oncology Institute of Hope & Innovation

    Miami, Florida, 33169

    562-693-4477

    Edgardo Santos, MD

    Recruiting

  • ChristianaCare Health Services

    Newark, Delaware, 19713

    Active, not recruiting

  • Oklahoma University Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

    Shae Pfenning, RN, 405-271-8001 ext. 18001, Shae-Pfenning@ouhsc.edu

    Minh Phan, md

    Recruiting

  • Oncology Hematology West, PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    402-334-4773

    Yungpo B. Su, MD

    Recruiting

  • Mid Florida Hematology and Oncology Center

    Orange City, Florida, 32763

    866-977-6322

    Santosh Nair, MD

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Jennifer Ruth, 412-623-4522, Ruthj2@upmc.edu

    Justin Siegel, 412-623-4522, siegeljt@upmc.edu

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Active, not recruiting

  • VCU Massey Comprehensive Cancer Center

    Richmond, Virginia, 23298

    Elisabeth Holmes, 804-628-2622, masseyirb@vcu.edu

    Erin Alesi, MD

    Recruiting

  • Sutter Health

    Sacramento, California, 95816

    Withdrawn

  • UC Davis

    Sacramento, California, 95817

    Terminated

  • Medical Oncology Associates of San Diego

    San Diego, California, 92123

    Amanda Somo, 858-637-7860, asomo@oncologysandiego.com

    Steven Kossman, MD

    Recruiting

  • Christus St. Vincent Regional Cancer Center

    Santa Fe, New Mexico, 87505

    505-913-8900

    Andrea Teague, MD

    Recruiting

  • Sarcoma Oncology Center

    Santa Monica, California, 90403

    310-499-8851

    Neal Chawla, MD

    Recruiting

  • Washington University St. Louis

    St Louis, Missouri, 63110

    314-747-6475

    Jesse Zaretsky, MD

    Recruiting

  • Cleveland Clinic Florida, The Maroone Cancer Center

    Weston, Florida, 33331

    Active, not recruiting

Other trials in United States

Spain9 sites

  • Complexo Hospitalario Universitario A Coruña

    A Coruña, 15006

    Active, not recruiting

  • Intituto Catalán de Oncología

    Barcelona, Catalonia, 08908

    Active, not recruiting

  • IOB / Institute of Oncology, Hospital Quirónsalud Barcelona

    Barcelona, Gracia, 08023

    Active, not recruiting

  • Hospital Clinic de Barcelona

    Barcelona, 08036

    Active, not recruiting

  • Hospital Universitario Gregorio Marañón

    Madrid, Retiro, 28007

    Active, not recruiting

  • MD Anderson Cancer Centre

    Madrid, 28033

    Active, not recruiting

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008

    Active, not recruiting

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago, A Coruña, 15706

    Active, not recruiting

  • Hospital Universitario y Politécnico La Fe

    Valencia

    Active, not recruiting

Other trials in Spain

South Korea8 sites

  • Keimyung University Dongsan Hospital of Korea

    Daegu, 42601

    Active, not recruiting

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, Eunpyeong-gu, 03312

    Active, not recruiting

  • Gachon University Gil Medical Center of Korea

    Seoul, Incheon, 21565

    Active, not recruiting

  • Korea Cancer Center Hospital

    Seoul, 01812

    Active, not recruiting

  • Korea University Anam Hospital

    Seoul, 02841

    Active, not recruiting

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

    Active, not recruiting

  • Korea University Guro Hospital

    Seoul, 08308

    Active, not recruiting

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, 50612

    Active, not recruiting

Other trials in South Korea

United Kingdom8 sites

  • NHS Grampian / Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN

    Active, not recruiting

  • Addenbrooke's Hospital

    Cambridge, CB2 0QQ

    Active, not recruiting

  • The Royal Marsden NHS Foundation Trust, Chelsea

    Chelsea, London, SW36JJ

    Active, not recruiting

  • The Christie NHS Foundation Trust

    Manchester, M204BX

    Active, not recruiting

  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Northern Centre for Cancer Care, Freeman Hospital

    Newcastle upon Tyne, Northumbria, NE7 7DN

    Active, not recruiting

  • Mount Vernon Cancer Centre

    Northwood, Middlesex, HA6 2RN

    Active, not recruiting

  • Norwich and Norfolk University Hospital

    Norwich, NR47UY

    Active, not recruiting

  • The Royal Marsden NHS Foundation Trust, Sutton

    Sutton, Surrey, SM25PT

    Active, not recruiting

Other trials in United Kingdom

Taiwan7 sites

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    Changhua, 500

    Active, not recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

    Active, not recruiting

  • Taichung Veterans General Hospital

    Taichung, China, 407219

    Active, not recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Active, not recruiting

  • Taipei Veterans General Hospital

    Taipei, Beitou District / R.o.c., 11217

    Active, not recruiting

  • National Taiwan University Hospital

    Taipei, 100226

    Active, not recruiting

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei City, Taipei, 11259

    Active, not recruiting

Other trials in Taiwan

Malaysia6 sites

  • Hospital Canselor Tuanku Muhriz (HCTM) UKM

    Cheras, Kuala Lumpur, 56000

    Active, not recruiting

  • Hospital Universiti Sains Malaysia

    Kubang Kerian, Kelantan, 16150

    Active, not recruiting

  • Sarawak General Hospital

    Kuching, Sarawak, 93586

    Active, not recruiting

  • Thomson Hospital Kota Damansara

    Petaling Jaya, Selangor, 47810

    Active, not recruiting

  • Beacon Hospital

    Petaling Jaya, 46050

    Active, not recruiting

  • Institut Kanser Negara

    Putrajaya, 62250

    Active, not recruiting

Other trials in Malaysia

France5 sites

  • CH Annecy Genevois

    Annecy, Epagny Metz Tessy, 74370

    Active, not recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Active, not recruiting

  • Cenre Oscar Lambret

    Lille, 59000

    Active, not recruiting

  • Centre Leon Berard

    Lyon, 69008

    Active, not recruiting

  • UNEOS-Hopital R.SCHUMAN

    Metz, Moselle, 57000

    Active, not recruiting

Other trials in France

Belgium4 sites

  • Antwerp University Hospital

    Edegem, Antwerp, 2650

    Active, not recruiting

  • University Hospital Brussels

    Jette, 1090

    Active, not recruiting

  • Chu Ucl Namur Site De Sainte-Elisabeth

    Namur, 5000

    Active, not recruiting

  • Vitaz

    Sint-Niklaas, 9100

    Active, not recruiting

Other trials in Belgium

Bulgaria4 sites

  • Multiprofile Hospital for Active Treatment - "Uni Hospital" Ltd, Medical Oncology Dept

    Panagyurishte, 4500

    Active, not recruiting

  • Complex Oncological Center Plovdiv EOOD Dept of Med Oncology and Oncological Diseases in Hematology

    Plovdiv, 4004

    Active, not recruiting

  • Uni Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD Clinic of Medical Oncology

    Sofia, 1527

    Active, not recruiting

  • Multiprofile Hospital for Active Treatment Sveta Sofia, Department of Medical Oncology

    Sofia, 1618

    Active, not recruiting

Other trials in Bulgaria

Italy4 sites

  • Istituto Nazionale Tumori IRCCS - (National Cancer Institute)

    Milan, 20133

    Active, not recruiting

  • European Institute of Oncology

    Milan, 20141

    Active, not recruiting

  • Istituto Nazionale Tumori IRCCS - Fondazione Giovanni Pascale (National Cancer Institute)

    Naples, Naples, 80131

    Active, not recruiting

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

    Active, not recruiting

Other trials in Italy

Romania4 sites

  • ARENSIA Clinic Oncology Institute Bucharest

    Bucharest, 022328

    Active, not recruiting

  • Arensia Exploratory Medicine S.R.L in collaboration with "Prof. Dr. Ion Chiricuta" Oncology Institute

    Cluj-Napoca, Cluj, 400015

    Active, not recruiting

  • Sc Oncolab Srl

    Craiova, Dolj, 200385

    Active, not recruiting

  • Sc Centrul de Oncologie Sf Nectarie Srl

    Craiova, Dolj, 200745

    Active, not recruiting

Other trials in Romania

Poland3 sites

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Oddział w Gliwicach

    Gliwice, 44-102

    Active, not recruiting

  • Przychodnia Lekarska KOMED

    Konin, 62-500

    Active, not recruiting

  • Provita Profamilia

    Piotrkow Trybunalski, 97-300

    Active, not recruiting

Other trials in Poland

Australia1 site

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Active, not recruiting

Other trials in Australia

About this study

Official title: A Phase 2/3, Randomized Study of Ordastobart (INBRX-106) Plus Pembrolizumab vs Pembrolizumab as First-Line Treatment for Patients With Recurrent or Metastatic HPV-positive Oropharyngeal Squamous Cell Carcinoma Expressing PD-L1 (HexAgon-HN)

This seamless phase 2/3 randomized controlled study will evaluate the efficacy and safety of the hexavalent OX40 agonist antibody ordastobart (INBRX-106) combined with the anti-PD-1 antibody pembrolizumab versus pembrolizumab (+ placebo in phase 3) as first-line treatment for patients with recurrent or metastatic (R/M) HPV-positive Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC) expressing PD-L1.

Being tested
INBRX-106, Pembrolizumab
Keywords
OX40 receptor agonist, PD-L1 positive, Pembrolizumab, Immunotherapy, Chemotherapy-free, HNSCC, Head and Neck Cancer, Keytruda, Oropharyngeal cancer, INBRX-106, HPV positive, squamous cell carcinoma, OPSCC, ordastobart
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Oropharyngeal Neoplasms, Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INBRX-106Drug

    Also called Hexavalent OX40 agonist antibody, Ordastobart

    INBRX-106 0.1 mg/kg by intravenous (IV) infusion, given every 3 weeks (QW3)

  • PembrolizumabDrug

    Also called Keytruda

    Pembrolizumab 200 mg by intravenous (IV) infusion, given every 3 weeks (QW3)

Study groups in NCT06295731
Study groupRoleWhat they receive
ordastobart (INBRX-106) plus pembrolizumabExperimentalParticipants will receive INBRX-106 plus pembrolizumab, both given by intravenous (IV) infusion every 3 weeks (QW3)
Receives: Drug: INBRX-106; Drug: Pembrolizumab
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)
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 2: Objective Response Rate by investigator (ORRinv)

    defined as the proportion of patients with complete response (CR) or partial response (PR) on 2 consecutive occasions ≥4 weeks apart, as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).

    Measured: From randomization to progressive disease (PD) or death (up to 1 year)

  2. Phase 3: Progression-Free Survival by Investigator (PFSinv)

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

    Measured: From randomization to PD or death (up to 4 years)

  3. Phase 3: Overall Survival (OS)

    defined as the time from randomization to death from any cause.

    Measured: From randomization until death from any cause (up to 4 years)

Secondary outcomes (17)

  1. Phase 2 and 3: Objective Response Rate by Blinded Independent Review Committee (ORRbirc)

    defined as the proportion of patients with a CR or PR on 2 consecutive occasions ≥4 weeks apart, per RECIST 1.1

    Measured: From randomization to PD or death (up to 1 year)

  2. Phase 2 and 3: Duration of Response by Investigator and by BIRC (DORinv, DORbirc)

    defined as the time from the first occurrence of a documented objective response (CR/PR) until PD, both as determined by the Investigator or BIRC, respectively, according to RECIST 1.1, or death from any cause (whichever occurs first)

    Measured: From the first occurrence of a documented objective response to PD or death (up to 4 years)

  3. Phase 2 and 3: Clinical Benefit Rate (CBR) by Investigator and by BIRC

    defined as the proportion of patients with stable disease (SD) for ≥12 weeks or a CR or PR, as determined by the Investigator or BIRC respectively, according to RECIST 1.1.

    Measured: From randomization to PD or death (up to 1 year)

  4. Phase 2 and 3: Progression-free survival by BIRC (PFSbirc)

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

    Measured: From randomization to PD or death (up to 4 years)

  5. Phase 2 and 3: PFSinv and PFSbirc rates at 6, 9, 12 and 24 months

    defined as the proportion of patients who are progression-free, as determined by the Investigator or BIRC, respectively, according to RECIST 1.1, and alive 6, 9, 12 and 24 months after randomization.

    Measured: From randomization to PD or death, with landmark-specific timeframes (up to 2 years)

  6. Phase 2 and Phase 3: OS rates at 12 and 24 months

    defined as the proportion of patients who are alive 12 and 24 months after randomization.

    Measured: From randomization to death, with landmark-specific timeframes (up to 2 years)

  7. Phase 2: PFS by Investigator (PFSinv)

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

    Measured: From randomization to PD or death (up to 4 years)

  8. Phase 2: Overall Survival (OS)

    defined as the time from randomization to death from any cause

    Measured: From randomization to death (up to 4 years)

  9. Phase 3: Objective Response Rate by investigator (ORRinv)

    defined as the proportion of patients with CR or PR on 2 consecutive occasions ≥4 weeks apart, as determined by the Investigator according to RECIST 1.1.

    Measured: From randomization to progressive disease (PD) or death (up to 1 year)

  10. Phase 3: Time to Chemotherapy (TTCtx)

    defined as the time from randomization until the start date of chemotherapy or death from any cause (whichever occurs first).

    Measured: From randomization until the start of chemotherapy or death (up to 4 years)

  11. Phase 2 and Phase 3: Incidence and Severity of treatment-emergent Adverse Events (AEs)

    Incidence will be reported as the number of participants with at least one AE, with severity determined according to the National Cancer Institute Common Toxicity Criteria for Adverse Events, version 5 (NCI CTCAE v 5.0)

    Measured: From first study treatment dose until the end of protocol-defined safety follow-up period (up to 2 years)

  12. Phase 2 and Phase 3: Evaluate the safety and tolerability of study treatment

    Incidence of dose interruptions and treatment discontinuation.

    Measured: Up to approximately 24 months

  13. Phase 2 and Phase 3: Number of patients who experienced abnormalities in vital signs and clinical laboratory parameters

    Vital signs include respiratory rate, pulse rate, systolic and diastolic blood pressure, and temperature. Clinical laboratory parameter include hematology and biochemistry tests over the course of the study.

    Measured: From first study treatment dose until the end of protocol-defined safety follow-up period (up to 2 years)

  14. Phase 3: Time to Confirmed Deterioration (TTCD) in Pain Presence and Interference

    TTCD in pain presence and interference is defined as the time from randomization to the first documentation of ≥10-point increase in pain score, as determined using the European Organization for Research and Treatment of Cancer Quality of Life-Core 30 (EORTC QLQ-C30) questionnaire

    Measured: From randomization until treatment discontinuation (up to 2 years)

  15. Phase 3: TTCD in physical functioning (PF)

    defined as the time from randomization to the first documentation of a ≥10 point decrease from baseline in the EORTC QLQ-C30 linearly transformed PF scale score.

    Measured: From randomization until treatment discontinuation (up to 2 years)

  16. Phase 3: TTCD in role functioning (RF)

    defined as the time from randomization to the first documentation of a ≥10 point decrease from baseline in the EORTC QLQ-C30 linearly transformed RF scale score.

    Measured: From randomization until treatment discontinuation (up to 2 years)

  17. Phase 3: TTCD in Global Health Status/quality of life (GHS/QoL)

    defined as the time from randomization to the first documentation of a ≥10 point decrease from baseline in the EORTC QLQ-C30 linearly transformed GHS/QoL scale score.

    Measured: From randomization until treatment discontinuation (up to 2 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start14 May 2024
  3. Primary completionDec 2029 (estimated)
  4. Study completionMay 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06295731
Sponsor's protocol ID
INBRX106-01-201
Other IDs
EU CT
Acronym
HexAgon-HN
Status last verified
Oct 2026
First submitted
22 Feb 2024
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing INBRX-106 and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma (HNSCC) and HPV Oropharyngeal Squamous Cell Carcinoma (HPV+ OPSCC), run by Inhibrx Biosciences, Inc at 89 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Spain, South Korea, United Kingdom, Taiwan and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Director - Inhibrx (858-500-7833, clinicaltrials@inhibrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 2: Objective Response Rate by investigator (ORRinv) (time frame: From randomization to progressive disease (PD) or death (up to 1 year)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06295731.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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