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

  • Clinicaltrials.gov identifier

    NCT03927573

  • Recruitment Status

    Recruiting

  • First Posted

    April 25, 2019

  • Last update posted

    April 20, 2021

Study Description

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:Non-small Cell Lung Cancer
    Breast Cancer
    Pancreatic Cancer
    Transitional Cell Carcinoma
    Prostate Cancer
    Renal Cancer
  • Intervention/Treatment: Drug: GEM3PSCA
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • 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 2019
  • Estimated Primary Completion Date: June 2022
  • Estimated Study Completion Date: December 2022

Arms and interventions

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

Outcome Measures

  • 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) ]

Eligibility Criteria

  • 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

Contacts and Locations

Contacts

Contact: Susann Helas, Dr. +49 351 4466 4500 ext 0 gem3psca-01@gemoab.com

Contact: Martina Raupach ext 0

Locations

Germany, Bayern
Klinikum rechts der Isar der TU München
Munich

Germany, Bayern
Universitätsklinikum Würzburg
Würzburg

Germany, Hessen
Universitätsklinikum Marburg
Marburg

Germany, Sachsen
Universitätsklinikum Dresden
Dresden

Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg

Sponsors and Collaborators

GEMoaB Monoclonals GmbH

GCP-Service International Ltd. & Co. KG

Investigators

Principal Investigator: Ralf Bargou, Prof. Dr. Universitätsklinikum Würzburg, CCC Mainfranken

More Information

  • 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: April 20, 2021
  • Last Verified: April 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Carcinoma, Transitional Cell Kidney Neoplasms