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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03927573
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : July 15, 2022
GCP-Service International Ltd. & Co. KG
Information provided by (Responsible Party):
AvenCell Europe 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 Prostate Cancer Renal Cancer Transitional Cell Carcinoma Drug: GEM3PSCA Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
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 2022
Estimated Study Completion Date : June 2023

Arm Intervention/treatment
Experimental: GEM3PSCA
Application of GEM3PSCA, a PSCA targeted bispecific antibody engaging T-cells
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) ]
  5. Influence on circulating tumor cells in patients with prostate cancer [ Time Frame: Day 8 / End of Treatment (EOT) ]

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

Inclusion Criteria:

  1. Male or female patients, ≥ 18 years of age
  2. Progressive PSCA positive cancer (urogenital tract (renal, transitional cell, prostate), non-small cell lung) 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) ≥ 90 % 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 active brain metastases (patients with brain metastases or residue after resection with stable size for 6 months in MRI not older than 8 weeks, after consultation with the sponsor, are not excluded from the trial)
  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

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Contact: Ariane Klemm +49 351 4466 4500 ext 0 gem3psca-01@avencell.com
Contact: Martina Raupach gem3psca-01@avencell.com

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Klinikum rechts der Isar der TU München Recruiting
Munich, Bayern, Germany, 81675
Contact: Sylvie Lorenzen, Prof. Dr.         
Principal Investigator: Sylvie Lorenzen, Prof. Dr.         
Universitätsklinikum Würzburg Recruiting
Würzburg, Bayern, Germany, 97080
Contact: Mariele Goebeler, Dr.         
Principal Investigator: Ralf Bargou, Prof. Dr.         
Universitätsklinikum Marburg Recruiting
Marburg, Hessen, Germany, 35043
Contact: Stephan Metzelder, Dr.         
Principal Investigator: Stephan Metzelder, PD Dr.         
Universitätsklinikum Dresden Recruiting
Dresden, Sachsen, Germany, 01307
Contact: Martin Wermke, Dr.         
Principal Investigator: Martin Wermke, Dr.         
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Principal Investigator: Gunhild von Amsberg, Prof. Dr.         
Sponsors and Collaborators
AvenCell Europe GmbH
GCP-Service International Ltd. & Co. KG
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Principal Investigator: Ralf Bargou, Prof. Dr. Universitätsklinikum Würzburg, Interdisziplinäres Studienzentrum mit ECTU
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Responsible Party: AvenCell Europe GmbH
ClinicalTrials.gov Identifier: NCT03927573    
Other Study ID Numbers: GEM3PSCA-01
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022
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, Transitional Cell
Kidney Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urogenital Diseases
Male Urogenital Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Kidney Diseases
Urologic Diseases