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

Brief Title

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

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

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.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Maximum tolerated dose (MTD)

Secondary Outcome

 Recommended phase 2 dose (RP2D)

Condition

Non-small Cell Lung Cancer

Intervention

GEM3PSCA

Study Arms / Comparison Groups

 GEM3PSCA

Description:  Application of GEM3PSCA, a PSCA targeted bispecific antibody engaging T-cells

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

24

Start Date

April 15, 2019

Completion Date

December 2022

Primary Completion Date

June 2022

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ralf Bargou, Prof. Dr., +49 351 4466 4500, [email protected]

Location Countries

Germany

Location Countries

Germany

NCT ID

NCT03927573

Organization ID

GEM3PSCA-01

Responsible Party

Sponsor

Study Sponsor

GEMoaB GmbH

Collaborators

 GCP-Service International Ltd. & Co. KG

Study Sponsor

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

Verification Date

August 2021