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Study With Bispecific Antibody Engaging T-cells, in Patients With Progressive Cancer Diseases With Positive PSCA Marker

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ClinicalTrials.gov Identifier: NCT03927573
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
GCP-Service International Ltd. & Co. KG
Information provided by (Responsible Party):
GEMoaB Monoclonals GmbH

Brief Summary:
This dose-escalating phase I trial assesses for the first time the safety, the side effects and the harmlessness, as well as the therapeutical benefit of the new study drug GEM3PSCA in patients with prostate stem cell antigen (PSCA) expressing cancer types which failed to respond to standard therapy.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Breast Cancer Pancreatic Cancer Urogenital Cancer Drug: GEM3PSCA Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation scheme; Single patient cohorts on the first three dose levels, 3+3 afterwards.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Dose-escalating, Phase I Trial With GEM3PSCA, a PSCA Targeted Bispecific Antibody Engaging T-cells, in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSCA Marker
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GEM3PSCA
Application of GEM3PSCA, a PSCA targeted bispecific antibody engaging T-cells
Drug: GEM3PSCA
Infusion of GEM3PSCA, administered intravenously, continuously over 7 days, 2 cycles




Primary Outcome Measures :
  1. Maximum tolerated dose (MTD) [ Time Frame: End of Treatment (EOT) +14 days (DLT period) ]
    MTD is the previous dose level of the cohort where a DLT is observed in at least wo subjects.

  2. Incidence and intensity of adverse events [ Time Frame: End of Treatment (EOT) +14 days (DLT period) ]
    graded according to CTCAE V4.03

  3. Incidence of Dose limiting toxicity (DLT) [ Time Frame: End of Treatment (EOT) +14 days (DLT period) ]
    Dose Limiting Toxicity is defined as any event at least possibly related to investigational medicinal product (IMP)


Secondary Outcome Measures :
  1. Recommended phase 2 dose (RP2D) [ Time Frame: From start of treatment until up to 14 days after last treatment cycle (2 initial cycles + max. 6 additional cycles per patient). Each cycle consists of 7 days treatment plus DLT evaluation period (14 days) ]
    The RP2D will be determined based on MTD, all available efficacy data, and all available safety data, including information derived from additional treatment cycles.

  2. Antitumor activity of GEM3PSCA according to RECIST1.1 (Response Evaluation Criteria in Solid Tumors) [ Time Frame: End of Treatment (EOT) +14 days (DLT period) ]
    response rates

  3. Prostate specific antigen (PSA) response in patients with prostate cancer [ Time Frame: End of Treatment (EOT) +14 days (DLT period) ]
  4. Overall survival (OS) [ Time Frame: End of Treatment (EOT) + 14 days (DLT period) ]


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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:

  1. Male or female patients, ≥ 18 years of age
  2. PSCA positive cancer (i.e. urogenital tract (renal, transitional cell, prostate), non-small cell lung, breast and pancreatic cancer) refractory to standard treatments and with no other available standard or curative treatment
  3. Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  5. Life expectancy of at least 2 months
  6. Platelets > 50,000/µl
  7. Hemoglobin > 9 g/dl
  8. Adequate renal and hepatic laboratory assessments
  9. Adequate pulmonary function with oxygen saturation (SpO2) > 89 % and no structural pulmonary disease which might jeopardize patient safety according to judgement of the investigator
  10. Left ventricular ejection fraction (LVEF) of ≥ 45 %
  11. Existing port-system or central venous catheter resp. acceptance of implantation of a device
  12. A female of childbearing potential may be enrolled providing she has a negative pregnancy test at screening visit and is routinely using a highly effective method of birth control resulting in a low failure rate (e.g. hormonal contraception, intrauterine device, total sexual abstinence or sterilization) until 3 months from the last study drug administration. Male patients must also practice a highly effective method of birth Control
  13. Able to give written informed consent

Exclusion Criteria:

  1. Other malignancy requiring active therapy
  2. Non-measurable tumor disease
  3. Patients with brain metastases
  4. Use of chemotherapy and radiotherapy within 2 weeks prior to start of trial medication
  5. Use of checkpoint inhibitors (having a marketing authorization) within a washout of 5 x t1/2 (half-life); patients with experimental checkpoint inhibitors at all
  6. Other investigational drug within the past 4 weeks before start of trial medication
  7. Patients undergoing renal dialysis
  8. Pulmonary disease with clinical relevant hypoxia
  9. Evidence of active, non-infectious pneumonitis or history of interstitial lung disease
  10. Cardiac disease: i.e. heart failure NYHA (New York Heart Association) III or IV, unstable coronary artery disease
  11. Active central nervous disease (e.g. Parkinson, multiple sclerosis, seizures) and stroke within last 6 months
  12. Active gastrointestinal ulceration or bleeding within the last 6 months unless related to underlying malignant disease
  13. Renal outflow obstruction, macroscopic or significant microscopic hematuria
  14. Active infectious diseases considered by investigator to be incompatible with protocol
  15. Major surgery within 28 days
  16. Autoimmune diseases requiring steroids at a dose above 10 mg prednisolone equivalent or other immunosuppressants
  17. Pregnant or breastfeeding women
  18. Psychiatric disorders, drug and/or alcohol abuse
  19. Known history of human immunodeficiency virus (HIV) or active/chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)
  20. Known hypersensitivity to GEM3PSCA excipients
  21. Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)
  22. Incapability of understanding purpose and possible consequences of the trial
  23. Patients who should not be included according to the opinion of the investigator

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): NCT03927573


Contacts
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Contact: Susann Helas, Dr. +493514466450 ext 0 s.helas@cellex-treatment.me
Contact: Jana Hase +493514466450 ext 0 j.hase@cellex-treatment.me

Locations
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Germany
Universitätsklinikum Würzburg Recruiting
Würzburg, Bayern, Germany, 97080
Contact: Mariele Goebeler, MD       Goebeler_M@ukw.de   
Principal Investigator: Ralf Bargou, Prof. Dr.         
Universitätsklinikum Dresden Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Martin Wermke, MD       martin.wermke@uniklinikum-dresden.de   
Principal Investigator: Martin Wermke, MD         
Sponsors and Collaborators
GEMoaB Monoclonals GmbH
GCP-Service International Ltd. & Co. KG
Investigators
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Principal Investigator: Ralf Bargou, Prof. Dr. Universitätsklinikum Würzburg, CCC Mainfranken

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Responsible Party: GEMoaB Monoclonals GmbH
ClinicalTrials.gov Identifier: NCT03927573     History of Changes
Other Study ID Numbers: GEM3PSCA-01
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Pancreatic Neoplasms
Urogenital Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Antibodies
Immunoglobulins
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs