Solid TumorPhase 1/2NCT04198766
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
A Phase 1/2 study testing INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab 200 mg and pembrolizumab 400 mg in people with Solid Tumor and Non-Small Cell Lung Cancer, run by Inhibrx Biosciences, Inc at 60 sites in 4 countries.
Trial summary
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer
- What is being tested?
- INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab 200 mg and pembrolizumab 400 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 60 sitesin 4 countries
- Study dates
- 10 Dec 2019to Jul 2033
- Phase
- Phase 1/2
- 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
Select Inclusion Criteria:
- Males or females aged ≥18 years.
- Parts 1 and 3 (escalation cohorts): Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.
- Part 2 (single-agent expansion cohort): Subjects with NSCLC, melanoma, HNSCC, G/GEA, RCC, or TCC, with histologically confirmed, locally advanced or metastatic, non-resectable disease, which has progressed despite all standard therapies including CPI or for whom no standard or clinically acceptable therapy exists.
- Part 4 (expansion cohorts in combination with pembrolizumab, with or without chemotherapy): Subjects with melanoma (all types), HNSCC, G/GEA, RCC, TCC, NSCLC, or MSI-high, TMB-high, MMR-deficient tumors, with histologically confirmed, locally advanced or metastatic, non resectable disease, which is either CPI-naive (melanoma, HNSCC, NPC) or progressed despite all standard therapies including CPI (NSCLC, RCC, TCC, uveal melanoma, MSI-high, TMB-high, or MMR-deficient solid tumors) or for whom no standard or clinically acceptable therapy exists.
- For Cohort F3 (NSCLC), subjects may have progressed on no more than 2 lines of standard therapy that must include at least one PD-1/L1 regimen.
- For Cohort F4 (HNSCC and NPC), subjects may be previously treated with no more than 1 prior chemotherapy regimen in metastatic setting. Prior PD-1/L1 in curative (neo-adjuvant/adjuvant) setting is allowed only if completed >/= 6 months prior to progression to local recurrence or metastatic disease.
- For Cohort F8, subjects must have previously untreated, histologically confirmed Stage II, IIIA or IIIB (T3-4N2) NSCLC. Lymph node disease requires histologic confirmation, while T3 disease requires only radiographic documentation. Subjects need to be able to undergo planned surgery.
- All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements.
- PD-L1 by IHC (22C3): Parts 1 and 3: IHC optional. Part 2: IHC result mandatory but any score allowed. Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). Part 4: Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). For Cohort F8, any TPS (including 0%) is acceptable.
- Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol.
Select Exclusion Criteria:
- Prior exposure to OX40 agonists. Exposure to anti-PD-1 and/or anti PD-L2 CPIs or an agent targeting other co-stimulatory T-cell receptor pathways.
- Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug with certain exceptions.
- Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)
- Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-106.
- Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.
- Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.
- Diagnosis of immunodeficiency or treatment with systemic immunosuppressive medications within 7 days prior to the first dose of study drug. Certain exceptions as defined in protocol apply.
- History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Exceptions as defined in protocol apply.
- Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
- Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, viral myocarditis, cerebrovascular accident, or other acute uncontrolled heart disease < 3 months prior to enrollment on this trial; left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension; or oxygen saturation <92% on room air.
- Active, hemodynamically significant pulmonary embolism within 12 weeks prior to enrollment on this trial.
- Major surgery within 4 weeks prior to enrollment on this trial.
- Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug.
- Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.
- Additional in- and exclusion criteria per protocol.
Trial locations and contacts
60 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
60 sites in 4 countries
United States39 sites, 22 recruiting
- Not yet recruiting
Lehigh Valley Health Network
Allentown, Pennsylvania, 18103
Muhammad Rizvi, MD
- Active, not recruiting
Winship Cancer Institute - Emory University
Atlanta, Georgia, 30322
- Completed
Intermountain Health Cancer Centers of Montana
Billings, Montana, 59102
- Not yet recruiting
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
Polina Khrizman, MD
- Not yet recruiting
University of Illinois Cancer Center
Chicago, Illinois, 60612
Frank Weinberg, MD, PhD
- Active, not recruiting
The University of Chicago Medical Center
Chicago, Illinois, 60637
- Recruiting
Clermont Oncology Center
Clermont, Florida, 34711
Kiran Penta, kiran@aorcorp.com
Gopal Kunta, MD
- Active, not recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Completed
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, 75230
- Completed
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
Henry Ford Cancer Institute
Detroit, Michigan, 48202
Mahmoud Hossami, 313-725-7842, mhossam1@hfhs.org
Amy Weise, MD
- Active, not recruiting
City of Hope
Duarte, California, 91010
- Completed
Renovatio Clinical - El Paso
El Paso, Texas, 79915
- Completed
Virginia Cancer Specialists
Fairfax, Virginia, 22031
- Recruiting
Oncura Health
Glendale, California, 91204
Elizabeth Brown, Elizabeth.Brown@lahomg.com
Sungwon Kyung, MD
- Not yet recruiting
Nebraska Cancer Specialists - Grand Island
Grand Island, Nebraska, 68803
Ralph Hauke, MD
- Active, not recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Jordan Harrelson, 319-467-5831, Jordan-harrelson@uiowa.edu
Douglas Laux, MD
- Not yet recruiting
University of Tennessee Health Science Center
Knoxville, Tennessee, 37923
Sean Jordan, MD
- Not yet recruiting
UC San Diego Health - Moores Cancer Center
La Jolla, California, 92037
Lyudmila Bazhenova, MD
- Not yet recruiting
Valkyrie Clinical Trials - Colorado
Lakewood, Colorado, 80228
Jason Henry, MD
- Recruiting
California Research Institute
Los Angeles, California, 90027
Swati Shrestha, sw@caresinst.com
Ghassan Al-Jazayrly, MD
- Not yet recruiting
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Jorge Nieva, MD
- Recruiting
Valkyrie Clinical Trials
Los Angeles, California, 90069
Myo Zaw, myo.zaw@valkyrieclinicaltrials.com
David Berz, MD
- Recruiting
Norton Cancer Institute
Louisville, Kentucky, 40202
Jenn Broadway, RN, 502-629-2500 ext. 19535, Jennifer.Broadway@nortonhealthcare.org
John Hamm, MD
- Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Ellen Smith, eksmith@mcw.edu
Jonathan Thompson, MD
- Recruiting
Valkyrie Clinical Trials
Murrieta, California, 92562
Isabella Gudino, Isabella.gudino@vctcare.com
David Berz, MD
- Active, not recruiting
Vanderbilt University School of Medicine
Nashville, Tennessee, 37204
- Recruiting
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
Lindsey Becker, 402-691-5255, lbecker@nebraskacancer.com
Ralph Hauke, MD
- Recruiting
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
Kiran Penta, kiran@aorcorp.com
Santosh Nair, MD
- Active, not recruiting
Providence Portland Medical Center
Portland, Oregon, 97213
- Active, not recruiting
HealthPartners Cancer Research Center
Saint Louis Park, Minnesota, 55426
- Completed
HealthPartners Cancer Research Center (Regions Hospital)
Saint Paul, Minnesota, 55101
- Completed
NEXT Oncology
San Antonio, Texas, 78229
- Recruiting
Providence Medical Foundation
Santa Rosa, California, 95403
Clinical Research Coordinator, 707-521-3810 ext. 1181, jackson.barnard@providence.org
Ian Anderson, MD
- Not yet recruiting
Washington University in St. Louis School of Medicine
St Louis, Missouri, 63110
Brett Herzog, MD, PhD
- Active, not recruiting
Montefiore Medical Center
The Bronx, New York, 10467
- Completed
Renovatio Clinical
The Woodlands, Texas, 77380
- Recruiting
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75701
Chaney Story, Chaney.Story@uttyler.edu
Erminia Massarelli, MD, PhD, MS
South Korea13 sites, 13 recruiting
- Not yet recruiting
Inje University College of Medicine
Busan
IL-Hwan Kim, MD, PhD
- Not yet recruiting
Chungbuk National University Hospital
Cheongju-si
Ki-Hyeong Lee, MD
- Recruiting
The Catholic University of Korea, St. Vincent's Hospital
Gyeonggi-do
Byoung Yong Shim
- Not yet recruiting
Chonnam National University Hwasun Hospital
Hwasun
In-Jae Oh, MD, MS, PhD
- Not yet recruiting
Gachon University Gil Medical Center
Incheon
Eun Kyung Cho, PhD, M.S
- Not yet recruiting
CHA Bundang Medical Center
Seongnam-si
Yoon Beom Sang
- Recruiting
Asan Medical Center
Seoul
Bokyeong Jung, RN, bokyeong_jung@amc.seoul.kr
Dae Ho Lee, MD
- Not yet recruiting
Hanyang University Seoul Hospital
Seoul
Myung- Ju Ahn, MD, PhD, MS
- Not yet recruiting
Korea University Anam Hospital
Seoul
Yoon Ji Choi, MD, MS, PhD
- Not yet recruiting
Korea University Guro Hospital
Seoul
Sung Yong Lee
Sung Yong Lee, MD, MS, PhD
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul
Miyeon Lee, lee_my@yuhs.ac
Sun Mun Lim
- Recruiting
The Catholic University of Korea Seoul St. Mary's Hospital,
Seoul
Na Ayn, Ahnna331@gmail.com
SookHee Hong
- Not yet recruiting
Ajou University Hospital
Suwon
Yong-Won Choi, MD
Taiwan5 sites
- Active, not recruiting
Changhua Christian Hospital (CCH)
Changhua
- Active, not recruiting
E-Da Cancer Hospital
Kaohsiung City
- Active, not recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
Kaohsiung City
- Active, not recruiting
National Cheng Kung University Hospital
Tainan
- Completed
Taipei Veterans General Hospital
Taipei
Singapore3 sites
- Completed
Curie Oncology
Singapore
- Completed
Icon Cancer Centre Farrer Park
Singapore
- Completed
Icon Cancer Centre Mount Alvernia
Singapore
About this study
Official title: An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.
- Conditions
- Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Melanoma, Gastric Cancer, Renal Cell Carcinoma
- Being tested
- INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab 200 mg, pembrolizumab 400 mg, Carboplatin AUC-5, Carboplatin AUC-6
- Keywords
- Phase 1 and Phase 2, Phase 1 and Phase 2 Clinical Trial, Solid Tumors, Head and Neck Cancer, Lung Cancer, Non-Small Cell Lung Cancer, OX40 receptor agonist, PD-L1 positive, Pembrolizumab, Keytruda, Chemotherapy, Immunotherapy, HNSCC, Oropharyngeal cancer, Hypopharyngeal cancer, Oral cancer, INBRX-106, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Neoplasms
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms, Melanoma, Stomach Neoplasms, Carcinoma, Renal Cell, Carcinoma, Transitional Cell, Lung Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INBRX-106 - Hexavalent OX40 agonist antibodyDrug
The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).
pembrolizumab 200 mgDrug
Also called KEYTRUDA
pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
pembrolizumab 400 mgDrug
Also called KEYTRUDA
pembrolizumab 400 mg by IV infusion given on Day 1 of alternating 21-day cycles (every 6 weeks)
Carboplatin AUC-5Drug
carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4. Cohort F8, carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycle 2-4.
Carboplatin AUC-6Drug
carboplatin AUC-6 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4
Pemetrexed 500 mg/m2Drug
Also called Alimta®
pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle for up to 35 cycles. In Cohort F8, pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle of cycles 1-4.
Cisplatin 75mg/m2Drug
cisplatin 75mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4
Paclitaxel 200mg/m2Drug
paclitaxel 200mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4
Nab paclitaxel 100mg/m2Drug
Nab paclitaxel 100mg/m2 by intravenous (IV) infusion, given on Days 1, 8 and 15 of each 21-day cycle of cycles 1-4
Gemcitabine (1000 mg/m2)Drug
Gemcitabine 1000 mg/m2 given by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle of cycles 1-4
| Study group | Role | What they receive |
|---|---|---|
| Part 1 INBRX-106 Escalation (Not Recruiting) | Experimental | INBRX-106 will be escalated in subjects with locally advanced or metastatic solid tumors. Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody |
| Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting) | Experimental | INBRX-106 will be escalated, in combination with pembrolizumab, in subjects with locally advanced or metastatic solid tumors. Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg |
| Part 2 (Cohorts C1/C2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting) | Experimental | Subjects with melanoma (any type), head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma or MSI/TMB-high tumors that are relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg |
| Part 2 (Cohort C3) INBRX-106 Escalation in NSCLC (Not Recruiting) | Experimental | Subjects with non-small cell carcinoma relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 Receives: Drug: pembrolizumab 200 mg |
| Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting) | Experimental | Subjects with non-small cell lung cancer will be treated with alternating dosing of INBRX-106 0.3 mg/kg Q6W and 400 mg pembrolizumab IV Q6W. This is one of the randomized cohorts. Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 400 mg |
| Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting) | Experimental | Subjects with non-small cell lung cancer will be given a 0.3 mg/kg priming dose of INBRX-106 in cycle 1, followed by 0.1 mg/kg INBRX-106 and 200 mg pembrolizumab IV every 3 weeks in subsequent cycles. This is one of the randomized cohorts. Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg; Drug: pembrolizumab 400 mg |
| Part 4 (Cohort F3c) Pembrolizumab Expansion Arm (Not Recruiting) | Active comparator | Subjects with non-small cell lung cancer will be treated with 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts. Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody |
| Part 4 (Cohort F3d) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not-Recruiting) | Experimental | Subjects with non-small cell lung cancer will be treated concurrently every 6 weeks with INBRX-106 0.1 mg/kg and 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts. Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody |
| Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumab (Not Recruiting) | Experimental | Subjects with melanoma (any type), head and neck squamous cell carcinoma (non-nasopharyngeal) OR nasopharyngeal carcinoma, MSI-high, TMB-high or MMR-deficient tumors, will be treated with INBRX-106 in combination with 200mg pembrolizumab IV every 3 weeks. Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg |
| Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI/TMB-high/MMRd tumors Not Recuriting | Experimental | Subjects with solid tumors that have confirmed MSI-high, TMB-high or MMR-deficient states who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg |
| Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting) | Experimental | Subjects with ocular (uveal) melanoma who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg; Drug: Carboplatin AUC-5; Drug: Pemetrexed 500 mg/m2 |
| Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC | Experimental | This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and carboplatin AUC-5 IV every 3 weeks Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg; Drug: Pemetrexed 500 mg/m2; Drug: Cisplatin 75mg/m2 |
| Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC | Experimental | This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and 75mg/m2 cisplatin IV every 3 weeks Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg; Drug: Carboplatin AUC-6; Drug: Paclitaxel 200mg/m2; Drug: Nab paclitaxel 100mg/m2 |
| Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC | Experimental | This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 200mg/m2 paclitaxel and carboplatin AUC-6 IV every 3 weeks OR INBRX-106, 200mg pembrolizumab, 100mg/m2 nab-paclitaxel (dosed Days 1,8 and 15 every cycle) and carboplatin AUC-6 IV every 3 weeks. Treating physician to determine if paclitaxel or nab-paclitaxel will be given Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg |
| Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC | Experimental | Subjects with resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC , any PD-L1 TPS will receive neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 (dosed Day 1 only) with gemcitabine 1000 mg/m2 (dosed on Days 1 and 8) for patients with squamous cell NSCLC given every 3 weeks OR neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 with pemetrexed 500 mg/m2 for patients with non-squamous cell NSCLC given every 3 weeks. Carboplatin AUC5 (dosed on Day 1 only) can be substituted for Cisplatin for subjects who are clinically considered ineligible or unsuitable for cisplatin per the Investigator's discretion or institution SOPs. Neoadjuvant treatment will be given for up to 4 cycles followed by surgery (lobectomy, bilobectomy or pneumonectomy). After surgery, all patients will receive adjuvant treatment consisting of INBRX-106 0.1 mg/kg, 200 mg pembrolizumab given every 3 weeks for up to 13 cycles. Receives: Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg; Drug: Carboplatin AUC-5; Drug: Pemetrexed 500 mg/m2; Drug: Cisplatin 75mg/m2; Drug: Gemcitabine (1000 mg/m2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Measured: ~2 years
Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Measured: ~2 years
MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-106 and INBRX-106 in combination with pembrolizumab
Measured: ~2 years
Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts
The evaluation of efficacy will be based on the subject's measurable disease using RECIST v1.1
Measured: ~2 years
Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC or resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Measured: ~2 years
To assess the antitumor activity of INBRX-106 in combination with pembrolizumab and platinum doublet chemotherapy as neoadjuvant/adjuvant therapy in adult subjects with NSCLC. (Cohort F8)
Major pathological response (mPR) and pathological complete response (cPR) criteria.
Measured: ~2 years
Secondary outcomes (5)
Area under the serum concentration time curve (AUC) of INBRX-106
Area under the serum concentration time curve (AUC) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.
Measured: ~2 years
Maximum observed serum concentration (Cmax) of INBRX-106
Maximum observed serum concentration (Cmax) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.
Measured: ~2 years
Trough observed serum concentration (Ctrough) of INBRX-106
Trough observed serum concentration (Ctrough) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.
Measured: ~2 years
Time to Cmax (Tmax) of INBRX-106
Time to Cmax (Tmax) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.
Measured: ~2 years
Immunogenicity of INBRX-106
Frequency of anti-drug antibodies (ADA) against INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.
Measured: ~2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start10 Dec 2019
- Primary completionJul 2033 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inhibrx Biosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Clinical Lead, Study director, Inhibrx Biosciences, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04198766
- Sponsor's protocol ID
- Ph 1 Ph 2 INBRX-106
- Other IDs
- KEYNOTE A99 and MK-3475-A99
- Status last verified
- Nov 2026
- First submitted
- 11 Dec 2019
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holay N, Yadav R, Ahn SJ, Kasiewicz MJ, Polovina A, Rolig AS, Staebler T, Becklund B, Simons ND, Koguchi Y, Eckelman BP, de Durana YD, Redmond WL. INBRX-106: a hexavalent OX40 agonist that drives superior antitumor responses via optimized receptor clustering. J Immunother Cancer. 2025 May 21;13(5):e011524. doi: 10.1136/jitc-2025-011524.
PubMed 40404202
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04198766
- Acronym / sponsor ID
- Ph 1 Ph 2 INBRX-106
- Conditions
- Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Melanoma, Gastric Cancer, Renal Cell Carcinoma
- Keywords
- Phase 1 and Phase 2, Phase 1 and Phase 2 Clinical Trial, Solid Tumors, Head and Neck Cancer, Lung Cancer, Non-Small Cell Lung Cancer, OX40 receptor agonist, PD-L1 positive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Inhibrx Biosciences, IncIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- Jul 2033 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 13 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Part 1 INBRX-106 Escalation (Not Recruiting) | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibodyINBRX-106 will be escalated in subjects with locally advanced or metastatic solid tumors. |
| Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting) | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibody, Drug: pembrolizumab 200 mgINBRX-106 will be escalated, in combination with pembrolizumab, in subjects with locally advanced or metastatic solid tumors. |
| Part 2 (Cohorts C1/C2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting) | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibody, Drug: pembrolizumab 200 mgSubjects with melanoma (any type), head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma or MSI/TMB-high tumors that are relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 |
| Part 2 (Cohort C3) INBRX-106 Escalation in NSCLC (Not Recruiting) | Experimental | Drug: pembrolizumab 200 mgSubjects with non-small cell carcinoma relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 |
| Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting) | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibody, Drug: pembrolizumab 400 mgSubjects with non-small cell lung cancer will be treated with alternating dosing of INBRX-106 0.3 mg/kg Q6W and 400 mg pembrolizumab IV Q6W. This is one of the randomized cohorts. |
| Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting) | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibody, Drug: pembrolizumab 200 mg, Drug: pembrolizumab 400 mgSubjects with non-small cell lung cancer will be given a 0.3 mg/kg priming dose of INBRX-106 in cycle 1, followed by 0.1 mg/kg INBRX-106 and 200 mg pembrolizumab IV every 3 weeks in subsequent cycles. This is one of the randomized cohorts. |
| Part 4 (Cohort F3c) Pembrolizumab Expansion Arm (Not Recruiting) | Active comparator | Drug: INBRX-106 - Hexavalent OX40 agonist antibodySubjects with non-small cell lung cancer will be treated with 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts. |
| Part 4 (Cohort F3d) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not-Recruiting) | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibodySubjects with non-small cell lung cancer will be treated concurrently every 6 weeks with INBRX-106 0.1 mg/kg and 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts. |
| Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumab (Not Recruiting) | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibody, Drug: pembrolizumab 200 mgSubjects with melanoma (any type), head and neck squamous cell carcinoma (non-nasopharyngeal) OR nasopharyngeal carcinoma, MSI-high, TMB-high or MMR-deficient tumors, will be treated with INBRX-106 in combination with 200mg pembrolizumab IV every 3 weeks. |
| Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI/TMB-high/MMRd tumors Not Recuriting | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibody, Drug: pembrolizumab 200 mgSubjects with solid tumors that have confirmed MSI-high, TMB-high or MMR-deficient states who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks |
| Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting) | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibody, Drug: pembrolizumab 200 mg, Drug: Carboplatin AUC-5, Drug: Pemetrexed 500 mg/m2Subjects with ocular (uveal) melanoma who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks |
| Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibody, Drug: pembrolizumab 200 mg, Drug: Pemetrexed 500 mg/m2, Drug: Cisplatin 75mg/m2This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and carboplatin AUC-5 IV every 3 weeks |
| Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibody, Drug: pembrolizumab 200 mg, Drug: Carboplatin AUC-6, Drug: Paclitaxel 200mg/m2, Drug: Nab paclitaxel 100mg/m2This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and 75mg/m2 cisplatin IV every 3 weeks |
| Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibody, Drug: pembrolizumab 200 mgThis Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 200mg/m2 paclitaxel and carboplatin AUC-6 IV every 3 weeks OR INBRX-106, 200mg pembrolizumab, 100mg/m2 nab-paclitaxel (dosed Days 1,8 and 15 every cycle) and carboplatin AUC-6 IV every 3 weeks. Treating physician to determine if paclitaxel or nab-paclitaxel will be given |
| Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC | Experimental | Drug: INBRX-106 - Hexavalent OX40 agonist antibody, Drug: pembrolizumab 200 mg, Drug: Carboplatin AUC-5, Drug: Pemetrexed 500 mg/m2, Drug: Cisplatin 75mg/m2, Drug: Gemcitabine (1000 mg/m2)Subjects with resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC , any PD-L1 TPS will receive neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 (dosed Day 1 only) with gemcitabine 1000 mg/m2 (dosed on Days 1 and 8) for patients with squamous cell NSCLC given every 3 weeks OR neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 with pemetrexed 500 mg/m2 for patients with non-squamous cell NSCLC given every 3 weeks. Carboplatin AUC5 (dosed on Day 1 only) can be substituted for Cisplatin for subjects who are clinically considered ineligible or unsuitable for cisplatin per the Investigator's discretion or institution SOPs. Neoadjuvant treatment will be given for up to 4 cycles followed by surgery (lobectomy, bilobectomy or pneumonectomy). After surgery, all patients will receive adjuvant treatment consisting of INBRX-106 0.1 mg/kg, 200 mg pembrolizumab given every 3 weeks for up to 13 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INBRX-106 - Hexavalent OX40 agonist antibodyThe active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4). | Drug | Part 1 INBRX-106 Escalation (Not Recruiting), Part 2 (Cohorts C1/C2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting), Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting), Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting), Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting), Part 4 (Cohort F3c) Pembrolizumab Expansion Arm (Not Recruiting), Part 4 (Cohort F3d) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not-Recruiting), Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumab (Not Recruiting), Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI/TMB-high/MMRd tumors Not Recuriting, Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting), Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC, Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC, Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC, Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC |
| pembrolizumab 200 mgAlso: KEYTRUDApembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle. | Drug | Part 2 (Cohort C3) INBRX-106 Escalation in NSCLC (Not Recruiting), Part 2 (Cohorts C1/C2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting), Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting), Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting), Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumab (Not Recruiting), Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI/TMB-high/MMRd tumors Not Recuriting, Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting), Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC, Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC, Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC, Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC |
| pembrolizumab 400 mgAlso: KEYTRUDApembrolizumab 400 mg by IV infusion given on Day 1 of alternating 21-day cycles (every 6 weeks) | Drug | Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting), Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting) |
| Carboplatin AUC-5carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4. Cohort F8, carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycle 2-4. | Drug | Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting), Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC |
| Carboplatin AUC-6carboplatin AUC-6 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4 | Drug | Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC |
| Pemetrexed 500 mg/m2Also: Alimta®pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle for up to 35 cycles. In Cohort F8, pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle of cycles 1-4. | Drug | Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting), Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC, Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC |
| Cisplatin 75mg/m2cisplatin 75mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4 | Drug | Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC, Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC |
| Paclitaxel 200mg/m2paclitaxel 200mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4 | Drug | Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC |
| Nab paclitaxel 100mg/m2Nab paclitaxel 100mg/m2 by intravenous (IV) infusion, given on Days 1, 8 and 15 of each 21-day cycle of cycles 1-4 | Drug | Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC |
| Gemcitabine (1000 mg/m2)Gemcitabine 1000 mg/m2 given by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle of cycles 1-4 | Drug | Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC |
Primary outcome
Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab
Time frame: ~2 years
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab
Time frame: ~2 years
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab
Time frame: ~2 years
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-106 and INBRX-106 in combination with pembrolizumab
Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts
Time frame: ~2 years
The evaluation of efficacy will be based on the subject's measurable disease using RECIST v1.1
Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC or resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC
Time frame: ~2 years
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
To assess the antitumor activity of INBRX-106 in combination with pembrolizumab and platinum doublet chemotherapy as neoadjuvant/adjuvant therapy in adult subjects with NSCLC. (Cohort F8)
Time frame: ~2 years
Major pathological response (mPR) and pathological complete response (cPR) criteria.
5 secondary outcomes
Area under the serum concentration time curve (AUC) of INBRX-106
Time frame: ~2 years
Maximum observed serum concentration (Cmax) of INBRX-106
Time frame: ~2 years
Trough observed serum concentration (Ctrough) of INBRX-106
Time frame: ~2 years
Time to Cmax (Tmax) of INBRX-106
Time frame: ~2 years
Immunogenicity of INBRX-106
Time frame: ~2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Derived from this study: PubMed 40404202Holay N, Yadav R, Ahn SJ, Kasiewicz MJ, Polovina A, Rolig AS, Staebler T, Becklund B, Simons ND, Koguchi Y, Eckelman BP, de Durana YD, Redmond WL. INBRX-106: a hexavalent OX40 agonist that drives superior antitumor responses via optimized receptor clustering. J Immunother Cancer. 2025 May 21;13(5):e011524. doi: 10.1136/jitc-2025-011524.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Lead study director
Inhibrx Biosciences, Inc
60 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab 200 mg and pembrolizumab 400 mg in people with Solid Tumor and Non-Small Cell Lung Cancer, run by Inhibrx Biosciences, Inc at 60 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, South Korea, Taiwan, Singapore. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Biosciences, Inc (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?
Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab (time frame: ~2 years). The study lists 6 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 NCT04198766, which also lists 1 linked publication.
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 6 Nov 2026.