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Non-small Cell Lung CancerPhase 1NCT03927573

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

A Phase 1 study testing GEM3PSCA in people with Non-small Cell Lung Cancer and Prostate Cancer, run by AvenCell Europe GmbH at 5 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GEM3PSCA
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
5 sitesGermany
Study dates
15 Apr 2019to 28 Jun 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients, ≥ 18 years of age
  • 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
  • Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Life expectancy of at least 2 months
  • Platelets > 50,000/µl
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  • Hemoglobin > 9 g/dl
  • Adequate renal and hepatic laboratory assessments
  • Adequate pulmonary function with oxygen saturation (SpO2) ≥ 90 % and no structural pulmonary disease which might jeopardize patient safety according to judgement of the investigator
  • Left ventricular ejection fraction (LVEF) of ≥ 45 %
  • Existing port-system or central venous catheter resp. acceptance of implantation of a device
  • 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
  • Able to give written informed consent

Who cannot join

  • Other malignancy requiring active therapy
  • Non-measurable tumor disease
  • 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)
  • Use of chemotherapy and radiotherapy within 2 weeks prior to start of trial medication
  • 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
  • Other investigational drug within the past 4 weeks before start of trial medication
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  • Patients undergoing renal dialysis
  • Pulmonary disease with clinical relevant hypoxia
  • Evidence of active, non-infectious pneumonitis or history of interstitial lung disease
  • Cardiac disease: i.e. heart failure NYHA (New York Heart Association) III or IV, unstable coronary artery disease
  • Active central nervous disease (e.g. Parkinson, multiple sclerosis, seizures) and stroke within last 6 months
  • Active gastrointestinal ulceration or bleeding within the last 6 months unless related to underlying malignant disease
  • Renal outflow obstruction, macroscopic or significant microscopic hematuria
  • Active infectious diseases considered by investigator to be incompatible with protocol
  • Major surgery within 28 days
  • Autoimmune diseases requiring steroids at a dose above 10 mg prednisolone equivalent or other immunosuppressants
  • Pregnant or breastfeeding women
  • Psychiatric disorders, drug and/or alcohol abuse
  • Known history of human immunodeficiency virus (HIV) or active/chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)
  • Known hypersensitivity to GEM3PSCA excipients
  • Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)
  • Incapability of understanding purpose and possible consequences of the trial
  • Patients who should not be included according to the opinion of the investigator

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Germany5 sites

  • Universitätsklinikum Dresden

    Dresden, Saxony, 01307

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitätsklinikum Marburg

    Marburg, Hesse, 35043

  • Klinikum rechts der Isar der TU München

    Munich, Bavaria, 81675

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

About this study

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

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.

Being tested
GEM3PSCA
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Prostatic Neoplasms, Kidney Neoplasms, Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GEM3PSCADrug

    Infusion of GEM3PSCA, administered intravenously, continuously over 7 days, 2 cycles

Study groups in NCT03927573
Study groupRoleWhat they receive
GEM3PSCAExperimentalApplication of GEM3PSCA, a PSCA targeted bispecific antibody engaging T-cells
Receives: Drug: GEM3PSCA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD)

    MTD is the previous dose level of the cohort where a DLT is observed in at least wo subjects.

    Measured: End of Treatment (EOT) +14 days (DLT period)

  2. Incidence and intensity of adverse events

    graded according to CTCAE V4.03

    Measured: End of Treatment (EOT) +14 days (DLT period)

  3. Incidence of Dose limiting toxicity (DLT)

    Dose Limiting Toxicity is defined as any event at least possibly related to investigational medicinal product (IMP)

    Measured: End of Treatment (EOT) +14 days (DLT period)

Secondary outcomes (5)

  1. Recommended phase 2 dose (RP2D)

    The RP2D will be determined based on MTD, all available efficacy data, and all available safety data, including information derived from additional treatment cycles.

    Measured: 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)

  2. Antitumor activity of GEM3PSCA according to RECIST1.1 (Response Evaluation Criteria in Solid Tumors)

    response rates

    Measured: End of Treatment (EOT) +14 days (DLT period)

  3. Prostate specific antigen (PSA) response in patients with prostate cancer

    Measured: End of Treatment (EOT) +14 days (DLT period)

  4. Overall survival (OS)

    Measured: End of Treatment (EOT) + 14 days (DLT period)

  5. Influence on circulating tumor cells in patients with prostate cancer

    Measured: Day 8 / End of Treatment (EOT)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2019
  2. Study start15 Apr 2019
  3. Primary completion28 Jun 2023
  4. Study completion28 Jun 2023

Why it stopped: business decision by sponsor

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
Dose escalation scheme; Single patient cohorts on the first three dose levels, 3+3 afterwards.
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03927573
Sponsor's protocol ID
GEM3PSCA-01
Status last verified
Jul 2023
First submitted
16 Apr 2019
Last updated
10 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GEM3PSCA in people with Non-small Cell Lung Cancer and Prostate Cancer, run by AvenCell Europe GmbH at 5 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: business decision by sponsor). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: End of Treatment (EOT) +14 days (DLT period)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03927573.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.

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