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A Study of Sacituzumab Govitecan in Metastatic Solid Tumors (Tropics-03)

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ClinicalTrials.gov Identifier: NCT03964727
Recruitment Status : Not yet recruiting
First Posted : May 27, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.

Brief Summary:
A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU0132) in Subjects With Metastatic Solid Tumors

Condition or disease Intervention/treatment Phase
Metastatic Non-Small Cell Lung Carcinoma Head and Neck Squamous Cell Carcinoma Endometrial Cancer Hepatocellular Carcinoma Small Cell Lung Cancer Biological: IMMU-132 Phase 2

Detailed Description:
This is a multi-cohort, open-label, Phase 2 study designed to assess the clinical activity of sacituzumab govitecan in adult subjects with metastatic solid tumors. This study may enroll up to 6 histologic cohorts including subjects with NSCLC adenocarcinoma histology, NSCLC SCC histology, HNSCC, SCLC, endometrial cancer and HCC patients with Child Pugh B hepatic insufficiency.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Open Label Study of Sacituzumab Govitecan (IMMU-132) in Subjects With Metastatic Solid Tumors
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : August 2022


Arm Intervention/treatment
Experimental: IMMU-132
IMMU-132/Sacituzumab govitecan will be administered at 10 mg/kg as an intravenous infusion on days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.
Biological: IMMU-132
Sacituzumab govitecan will be administered at 10 mg/kg as an intravenous infusion on days 1 and 8 of a 21-day cycle until disease progression (PD), toxicity or withdrawal of consent.
Other Name: sacituzumab govitecan




Primary Outcome Measures :
  1. Objective Tumor Response Rates as assessed by RECIST 1.1 by Investigator Assessment [ Time Frame: through study completion, an average of 6 months ]
    Assess the clinical activity of sacituzumab govitecan in subjects with metastatic solid tumors according to objective tumor response rates through study completion, an average of 6 months


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) according to RECIST 1.1 by BICR and Investigator assessed [ Time Frame: every 6 weeks from Cyle1 Day 1 for 12 cycles (approximately 9 months) and then every 9 weeks until disease progression, study completion or up to approximately 2 years ]
    Overall Response Rate (ORR) , according to RECIST 1.1 by BICR and Investigator Assessment

  2. Duration of Response (DUR) according to RECIST 1.1 by BICR and Investigator assessed [ Time Frame: Every 6 weeks from Cyle1 Day 1 for 12 cycles (approximately 9 months) and then every 9 weeks until disease progression, study completion or up to approximately 2 years ]
    Duration Of Response (DUR) according to RECIST 1.1 by BICR and Investigator Assessment

  3. Progression free Survival (PFS) according to RECIST 1.1 by BICR and Investigator assessed [ Time Frame: Every 6 weeks from Cyle1 Day 1 for 12 cycles (approximately 9 months) and then every 9 weeks until disease progression, study completion or up to approximately 2 years ]
    Progression Free Survival (PFS) according to RECIST 1.1 by BICR and Investigator Assessment

  4. Assess safety evaluated by adverse events and serious adverse events as assessed by CTCAE v.5.0 [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess the safety evaluated by adverse events and serious adverse events

  5. Assess Safety as evaluated by blood pressure ( in mm/hg) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as evaluated by blood pressure ( in mm/hg)

  6. Assess Safety as evaluated by heart rate (beats per minute) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as evaluated by heart rate (beats per minute)

  7. Assess Safety as evaluated by respiratory rate (breaths per minute) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as evaluated by respiratory rate (breaths per minute)

  8. Assess Safety as evaluated by body temperature (Celsius) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Asess Safety as evaluated by body temperature (Celsius)

  9. Assess Safety as assessed by laboratory changes in complete blood count (CBC) (including white blood cell count, hemoglobin,platelet count and neutrophil count) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as assessed by laboratory changes in complete blood count (CBC) (including white blood cell count, hemoglobin,platelet count and neutrophil count

  10. Assess Safety as assessed by laboratory changes in chemistry including electrolytes (sodium, potassium, biocarbonate, sreum creatinine) [ Time Frame: through treatment completion, an average of 6 months and 30 days following last dose up to 24 months ]
    Assess Safety as assessed by laboratory changes in chemistry including electrolytes (sodium, potassium, biocarbonate, sreum creatinine)

  11. Trop-2 expression level and relationship with efficacy outcome overall response rate [ Time Frame: At end of treatment, and average of 6 months and 30 days following last dose up to 24 months ]
    Assess baseline Trop-2 expression and correlate to Overall response rate (ORR)

  12. Trop-2 expression level and relationship with efficacy outcome Progression free survival [ Time Frame: At end of treatment, and average of 6 months and 30 days following last dose up to 24 months ]
    Assess baseline Trop-2 expression and correlate to Progression Free Survival (PFS)

  13. Trop-2 expression level and relationship with efficacy outcome overall survival [ Time Frame: At end of treatment, and average of 6 months and 30 days following last dose up to 24 months ]
    Assess baseline Trop-2 expression and correlate to overall survival

  14. Assess Serum PK parameter Plasma Concentration (Cmax) [ Time Frame: through treatment completion, an average of 6 months ]
    Assess Serum PK parameter Plasma Concentration (Cmax)

  15. Assess Serum PK parameter Area Under the Curve (AUC) [ Time Frame: through treatment completion, an average of 6 months ]
    Assess Serum PK parameters including AUC,

  16. Assess Serum PK parameter Time to reach maximum concentration (Tmax) [ Time Frame: through treatment completion, an average of 6 months ]
    Assess Serum PK parameter Tmax

  17. Assess Anti-drug Antibody (ADA) Concentration [ Time Frame: through treatment completion, an average of 6 months ]
    Assess ADA Concentration


Other Outcome Measures:
  1. Assess DNA repair genes BRCA2 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA2 at baseline and correlate with efficacy outcomes

  2. Assess DNA repair genes BRCA2 and correlate to overall survival [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA2 at baseline and correlate with efficacy outcomes

  3. Assess DNA repair genes BRCA2 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA2 at baseline and correlate with efficacy outcomes

  4. Assess DNA repair genes BRCA1 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including to BRCA1 at baseline and correlate with efficacy outcomes

  5. Assess DNA repair genes BRCA1 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA1 at baseline and correlate with efficacy outcomes

  6. Assess DNA repair genes BRCA1 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including BRCA1 at baseline and correlate with efficacy outcomes

  7. Assess DNA repair genes RAD51 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including Rad51 at baseline and correlate with efficacy outcomes

  8. Assess DNA repair genes ATK1 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK1 at baseline and correlate with efficacy outcomes

  9. Assess DNA repair genes ATK2 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK2 at baseline and correlate with efficacy outcomes

  10. Assess DNA repair genes ATK3 and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK3 at baseline and correlate with efficacy outcomes

  11. Assess DNA repair genes ATM and correlate to overall response rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATM at baseline and correlate with efficacy outcomes

  12. Assess DNA repair genes RAD51 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including RAD51 at baseline and correlate with efficacy outcomes

  13. Assess DNA repair genes ATM and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including ATM at baseline and correlate with efficacy outcomes

  14. Assess DNA repair genes ATK1 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK1 at baseline and correlate with efficacy outcomes

  15. Assess DNA repair genes ATK2 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK2 at baseline and correlate with efficacy outcomes

  16. Assess DNA repair genes ATK3 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK3 at baseline and correlate with efficacy outcomes

  17. Assess DNA repair genes RAD51 and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including RAD51 at baseline and correlate with efficacy outcomes

  18. Assess DNA repair genes ATM and correlate to overall survival rate [ Time Frame: at baseline ]
    analyze DNA repair genes including ATM at baseline and correlate with efficacy outcomes

  19. Assess DNA repair genes ATK2 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK2 at baseline and correlate with efficacy outcomes

  20. Assess DNA repair genes ATK1 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK1 at baseline and correlate with efficacy outcomes

  21. Assess DNA repair genes ATK3 and correlate to progression free survival [ Time Frame: at baseline ]
    analyze DNA repair genes including ATK3 at baseline and correlate with efficacy outcomes



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Female or male subjects, >18 years of age, able to understand and give written informed consent.
  • Subjects with the following histologically documented metastatic (M1, Stage IV) or locally advanced solid tumors. NSCLC (adenocarcinoma or SCC), SCLC or HNSCC that has progressed after one line of platinum-based chemotherapy and PD-L1 or PD-1 directed therapy; recurrence/ relapse or lack of response within 6 months of completion of chemotherapy for locally advanced disease, that line of therapy may be counted for eligibility. Relapsed unresectable endometrial cancer that has progressed after prior platinum-based chemotherapy or is refractory to platinum-based chemotherapy. Relapsed HCC who have progressed after 2 approved lines of systemic therapy with Child Pugh B hepatic insufficiency
  • Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1 (see Appendix 1) except for the HCC cohort of subjects with moderate hepatic dysfunction where an ECOG of 2 may be permitted.
  • Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation
  • Adequate hepatic function except for subjects in the HCC cohort who may be enrolled if they meet Child Pugh B criteria (see Appendix 2).
  • Subject must have at least a 3-month life expectancy.
  • Have measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria (see Appendix 4). Tumor lesions situated in a previously irradiated area may be utilized if they are considered measurable and progression has been demonstrated in such lesions.

Exclusion Criteria:

  • Hepatitis B/C
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 and who has not recovered (i.e., ≤ Grade 2) from adverse events at the time of study entry. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 from adverse events due to a previously administered agent).
  • Has an active second malignancy. Note: Subjects with a history of malignancy that has been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or subjects with surgically-cured tumors with low risk of recurrence, are allowed to enroll.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline, have no evidence of new or enlarging brain metastases and are taking ≤10 mg/day of prednisone or its equivalent

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): NCT03964727


Contacts
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Contact: Immunomedics Medical Information 888-983-4668 MedInfo@Immunomedics.com

Sponsors and Collaborators
Immunomedics, Inc.
Investigators
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Study Chair: Trishna Goswami, MD Immunomedics, Inc.

Publications:

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Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT03964727     History of Changes
Other Study ID Numbers: Immu-132-11
First Posted: May 27, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019

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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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Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Hepatocellular
Small Cell Lung Carcinoma
Endometrial Neoplasms
Lung Neoplasms
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
Head and Neck Neoplasms