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A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05001347
Recruitment Status : Active, not recruiting
First Posted : August 11, 2021
Last Update Posted : November 15, 2022
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd. ( I-Mab Biopharma US Limited )

Study Description
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Brief Summary:
This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Head and Neck Cancer Non Small Cell Lung Cancer Gastrointestinal Cancer Triple Negative Breast Cancer Ovarian Carcinoma Drug: TJ004309 Phase 2

Detailed Description:
This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors. This clinical study includes two cohorts: Cohort 1 will include Immuno-Oncology (IO) treatment naïve ovarian cancer (OC) patients who have progressed on or after platinum therapy; and Cohort 2 will include patients with head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), gastrointestinal cancer (GC), triple negative breast cancer (TNBC), or ovarian carcinoma (OC) with PD-L1 expression ≥ 1%. Additional cohorts for selected tumor types might be added later.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Clinical Study of TJ004309 in Combination With Atezolizumab (TECENTRIQ®) in Patients With Advanced or Metastatic Ovarian Cancers and Selected Advanced Solid Tumors
Actual Study Start Date : November 2, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: TJ004309 and Atezolizumab
TJ004309 20 mg/kg Q3W in combination with atezolizumab 1200 mg Q3W
 Drug: TJ004309
Antibody to CD73


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate (ORR) in each Tumor Type [ Time Frame: Up to 120 weeks ]
    Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumors (RECIST v1.1) and iRECIST for target lesions assessed by CT or MRI


Secondary Outcome Measures :
  1. Incidence of treatment emergent adverse events [ Time Frame: Up to 120 weeks ]
    Treatment-emergent adverse event (TEAE) is assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0) Number of subjects with significant changes in vital signs, physical examinations, and clinical laboratory findings

  2. Number of participants with laboratory value abnormalities [ Time Frame: Up to 120 weeks ]
    Assessed by number of participants with clinically significant laboratory values.

  3. Number of participants with vital sign abnormalities [ Time Frame: Up to 120 weeks ]
    Assessed by number of participants with clinically significant vital sign values

  4. Number of participants with abnormal physical examination results [ Time Frame: Up to 120 weeks ]
    Assessed by number of participants with clinically significant abnormal physical examination results

  5. Objective Response Rate (ORR) [ Time Frame: Up to 120 weeks ]
    Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumors (RECIST v1.1) and iRECIST for target lesions assessed by CT or MRI

  6. Duration of response (DOR) [ Time Frame: Up to 120 weeks ]
    Time from documentation of tumor response to disease progression assessed among patients who had an objective response

  7. Disease control rate (DCR) [ Time Frame: Up to 120 weeks ]
    Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1

  8. Progression-free-survival (PFS) [ Time Frame: Up to 120 weeks ]
    by RECIST v1.1 and iRECIST

  9. Overall survival (OS) [ Time Frame: Up to 120 weeks ]
    Overall survival (OS) will be calculated for each subject as the number of days from the first day of treatment (Cycle 1 Day 1) to the date of death from any cause.

  10. Pharmacokinetic profiles of serum TJ004309 and atezolizumab [ Time Frame: Up to 120 weeks ]
    Based on Anti-Drug Antibody Results

  11. Pharmacokinetic (PK) parameters: Area under the curve (AUC0-T) [ Time Frame: From pre-dose in Day 1 of Cycle 1 to post-dose in Day 21 of Cycle 1 (each cycle is 21 days) ]
    AUC0-T is the area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval after the first infusion

  12. Assessment of PK parameter: Cmax [ Time Frame: From pre-dose in Day 1 of Cycle 1 to post-dose in Day 21 of Cycle 1 (each cycle is 21 days) ]
    Cmax is maximum drug concentration observed

  13. Assessment of PK parameter: tmax [ Time Frame: From pre-dose in Day 1 of Cycle 1 to post-dose in Day 21 of Cycle 1 (each cycle is 21 days) ]
    Time to reach Cmax


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cohort 1: Patients with histologically confirmed epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer subjects with any high-grade serous component, progressed on or after platinum-containing therapy and not eligible for further platinum containing treatment (platinum-resistant, platinum-refractory disease defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of receiving the last dose of platinum-based treatment).

  • Cohort 2: Patients with selected tumor types that have relapsed or progressed after 2 lines of therapy or who are ineligible for other standard of care (SOC) therapies:

    1. Histologically or cytologically confirmed metastatic NSCLC
    2. Histologically or cytologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, or larynx)
    3. Histologically or cytologically confirmed metastatic or non-resectable advanced metastatic gastric or gastroesophageal adenocarcinoma
    4. Histologically or cytologically confirmed unresectable, locally advanced or metastatic TNBC (confirmed HER2-negative, estrogen receptor-negative and progesterone receptor-negative)
    5. Histologically confirmed ovarian cancer of all high-grade epithelial types who are IO treatment naïve and have progressed after 3 months on or after platinum-containing therapy
    6. PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% for NSCLC and Combined Proportion Score (CPS) ≥ 1% for all other tumor types
    7. A 28-day washout period after the completion of programmed death-1 (PD-1)/PD-L1 therapy
    8. Patients should have no more than 5 prior lines of therapies
  • Cohort 2 - (Optional for the ovarian cohort) Pre-treatment fresh tumor biopsies and paired treatment fresh tumor biopsies will be collected from at least 5 patients. Biopsy must be excisional, incisional, or core.

Exclusion Criteria:

  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40 [Tumor necrosis factor receptor superfamily, member 4 (TNFRSF4)], CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]) (only applies to ovarian cancer patients in Cohorts 1 and 2)
  • Disease progression within 6 months of starting anti-PD-1 and anti-PD-L1 inhibitors
  • Known active or chronic Hepatitis B or Hepatitis C, other hepatitides (non-alcohol steatohepatitis, alcohol or drug-related, autoimmune) serology at screening or cirrhosis
  • Active autoimmune disease requiring systemic treatment within the past 12 months
  • Active interstitial lung disease (ILD) or pneumonitis or a history of ILD
  • Brain involvement with cancer, spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomeningeal disease; unless the lesion(s) have been radiated or resected, are considered fully treated and inactive, are asymptomatic, and no steroids have been administered for CNS disease over the 7 days prior to study treatment
  • Angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment
  • Known human immunodeficiency virus (HIV) unless CD4+ T cell count > 350 cells/μL with an undetectable viral load
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05001347


Locations
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Sponsors and Collaborators
I-Mab Biopharma US Limited
More Information
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Responsible Party: I-Mab Biopharma US Limited
ClinicalTrials.gov Identifier: NCT05001347    
Other Study ID Numbers: TJ004309STM103
First Posted: August 11, 2021    Key Record Dates
Last Update Posted: November 15, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Triple Negative Breast Neoplasms
Gastrointestinal Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
 Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Breast Neoplasms
Breast Diseases
Skin Diseases
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases