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

July 7, 2023 updated by: AvenCell Europe GmbH

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
    • Bayern
      • Munich, Bayern, Germany, 81675
        • Klinikum rechts der Isar der TU München
      • Würzburg, Bayern, Germany, 97080
        • Universitätsklinikum Würzburg
    • Hessen
      • Marburg, Hessen, Germany, 35043
        • Universitätsklinikum Marburg
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Universitätsklinikum Dresden

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.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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
End of Treatment (EOT) +14 days (DLT period)
Prostate specific antigen (PSA) response in patients with prostate cancer
Time Frame: End of Treatment (EOT) +14 days (DLT period)
End of Treatment (EOT) +14 days (DLT period)
Overall survival (OS)
Time Frame: End of Treatment (EOT) + 14 days (DLT period)
End of Treatment (EOT) + 14 days (DLT period)
Influence on circulating tumor cells in patients with prostate cancer
Time Frame: Day 8 / End of Treatment (EOT)
Day 8 / End of Treatment (EOT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AvenCell Europe GmbH

Collaborators

GCP-Service International Ltd. & Co. KG

Investigators

  • Principal Investigator: Ralf Bargou, Prof. Dr., Universitätsklinikum Würzburg, Interdisziplinäres Studienzentrum mit ECTU

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 Major Dates

Study Start (Actual)

April 15, 2019

Primary Completion (Actual)

June 28, 2023

Study Completion (Actual)

June 28, 2023

Study Registration Dates

First Submitted

April 16, 2019

First Submitted That Met QC Criteria

April 24, 2019

First Posted (Actual)

April 25, 2019

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEM3PSCA-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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