ACTIVE_NOT_RECRUITING

Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

Talk to us

Conditions

Solid TumorNon-Small Cell Lung CancerHead and Neck CancerMelanomaGastric CancerRenal Cell CarcinomaUrothelial CarcinomaPhase 1 and Phase 2Phase 1 and Phase 2 Clinical TrialSolid TumorsLung CancerOX40 receptor agonistPD-L1 positivePembrolizumabKeytrudaChemotherapyImmunotherapyHNSCCOropharyngeal cancerHypopharyngeal cancerOral cancerINBRX-106Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellHead and Neck NeoplasmsNeoplasms by SiteCarcinomaCarcinoma, Squamous CellMolecular Mechanisms of Pharmacological ActionAntineoplastic Agents, ImmunologicalAntineoplastic AgentsSquamous Cell Carcinoma of Head and NeckNSCLC

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2019-12-10
Study Completion:2027-05-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04198766

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males or females aged ≥18 years.
  2. * 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.
  3. * 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.
  4. * 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.
  5. * 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.
  6. * 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.
  7. * All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements.
  8. * 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).
  9. * Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol.
  1. * Prior exposure to OX40 agonists.
  2. * 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.
  3. * Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)
  4. * 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.
  5. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Exception: Subjects who are previously treated and are radiologically and clinically stable without the requirement for steroid treatment for at least 14 days prior to first dose of study treatment may be allowed study entry if certain criteria apply.
  6. * Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.
  7. * Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.
  8. * 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.
  9. * History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Exceptions as defined in protocol apply.
  10. * Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
  11. * Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease \< 3 months; 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.
  12. * Active, hemodynamically significant pulmonary embolism within 3 months prior to enrollment on this trial.
  13. * Major surgery within 4 weeks prior to enrollment on this trial.
  14. * Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug.
  15. * Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.
  16. * Additional in- and exclusion criteria per protocol.

Contacts and Locations

Principal Investigator

Clinical Lead
STUDY_DIRECTOR
Inhibrx Biosciences, Inc

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
Los Angeles Cancer Network
Glendale, California, 91204
United States
California Research Institute
Los Angeles, California, 90027
United States
Valkyrie Clinical Trials
Los Angeles, California, 90069
United States
Valkyrie Clinical Trials
Murrieta, California, 92562
United States
Providence Medical Foundation
Santa Rosa, California, 95403
United States
Clermont Oncology Center
Clermont, Florida, 34711
United States
Mid Florida Hematology and Oncology Center
Orange City, Florida, 32763
United States
Winship Cancer Institute - Emory University
Atlanta, Georgia, 30322
United States
The University of Chicago Medical Center
Chicago, Illinois, 60637
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Norton Cancer Institute
Louisville, Kentucky, 40202
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Henry Ford Cancer Institute
Detroit, Michigan, 48202
United States
START Midwest
Grand Rapids, Michigan, 49546
United States
HealthPartners Cancer Research Center
Saint Louis Park, Minnesota, 55426
United States
HealthPartners Cancer Research Center (Regions Hospital)
Saint Paul, Minnesota, 55101
United States
Intermountain Health Cancer Centers of Montana
Billings, Montana, 59102
United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130
United States
Montefiore Medical Center
The Bronx, New York, 10467
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Vanderbilt University School of Medicine
Nashville, Tennessee, 37204
United States
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, 75230
United States
Renovatio Clinical - El Paso
El Paso, Texas, 79915
United States
NEXT Oncology
San Antonio, Texas, 78229
United States
Renovatio Clinical
The Woodlands, Texas, 77380
United States
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75701
United States
Virginia Cancer Specialists
Fairfax, Virginia, 22031
United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Inhibrx Biosciences, Inc

  • Clinical Lead, STUDY_DIRECTOR, Inhibrx Biosciences, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-10
Study Completion Date2027-05-12

Study Record Updates

Study Start Date2019-12-10
Study Completion Date2027-05-12

Terms related to this study

Keywords Provided by Researchers

  • 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
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms
  • Neoplasms by Site
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Molecular Mechanisms of Pharmacological Action
  • Antineoplastic Agents, Immunological
  • Antineoplastic Agents
  • Squamous Cell Carcinoma of Head and Neck
  • NSCLC

Additional Relevant MeSH Terms

  • Solid Tumor
  • Non-Small Cell Lung Cancer
  • Head and Neck Cancer
  • Melanoma
  • Gastric Cancer
  • Renal Cell Carcinoma
  • Urothelial Carcinoma