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 Information
Recruitment Status
Drug
Estimated Enrollment
24
Start Date
April 15, 2019
Completion Date
June 2023
Primary Completion Date
December 2022
Eligibility Criteria
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
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
Administrative Informations
NCT ID
NCT03927573
Organization ID
GEM3PSCA-01
Responsible Party
Sponsor
Study Sponsor
AvenCell Europe GmbH
Collaborators
GCP-Service International Ltd. & Co. KG
Study Sponsor
Ralf Bargou, Prof. Dr., Principal Investigator, Universitätsklinikum Würzburg, Interdisziplinäres Studienzentrum mit ECTU
Verification Date
July 2022