Status:
COMPLETED
INVAC-1 Anti-Cancer hTERT DNA Immunotherapy
Lead Sponsor:
Invectys
Collaborating Sponsors:
Keyrus Biopharma
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
INVAC-1 is intended to be used for the treatment of adult patients with advanced solid tumors unresponsive to currently available therapies, or for whom no standard therapy is available.
Detailed Description
This is the first-in-patient study of INVAC-1, a DNA vaccine encoding human telomerase reverse transcriptase (hTERT). hTERT is the catalytic subunit of the telomerase complex which synthesizes telomer...
Eligibility Criteria
Inclusion
- Histological diagnosis of advanced/metastatic solid tumor malignancy
- Relapsed or refractory to standard treatment and for whom standard curative options do not exist
- Life-expectancy \> 4 months
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1
- A delay of at least 3 weeks between last specific anticancer treatment and first INVAC-1 injection
- Adequate skin status
- Lack of biologically documented inflammation: C Reactive Protein \< 15 mg/L
- No medical history of auto-immune disease
- Adequate bone marrow function
- Total white cells count ≤ 10 x 109/L (≤ 10,000/µL),
- Serum albuminemia \> 30 g/L
- Adequate renal function, with an estimated creatinine clearance ≥ 50 mL/min as calculated using the Cockroft \& Gault method
- Adequate liver function
- Adequate cardiac function
- Resolved acute effects of any prior therapy to baseline severity or Grade ≤ 1 CTCAE v. 4.03 except for Adverse Events not constituting a safety risk by investigator judgment
- Lack of immune-suppressive drugs and of high-dose corticoid treatment within 8 weeks prior to entering the study (prednisone or prednisolone ≤ 10 mg/day is allowed)
- Serum pregnancy test (for females of childbearing potential) negative within 7 days of first dose of study drug
- Female patients must be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. Male patients must be surgically sterile or must agree to use effective contraception during the period of the trial and for at least 90 days after completion of treatment. The decision of effective contraception will be based on the judgment of the principal investigator.
- Provision of written informed consent indicating that the patient has been informed of all the pertinent aspects of the trial to be followed
- Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Exclusion
- Central Nervous System (CNS) primary or CNS metastatic malignancies
- Prior allogeneic hematopoietic stem cell transplant
- Chemotherapy, cancer immunosuppressive therapy, growth factors, systemic steroids, or investigational agents within 28 days before the first dose of study treatment
- Prior therapy with a compound of the same mechanism (immunomodulation) in the last 90 days prior to first dose of study drug
- Participation to a clinical trial of an experimental medication in the last 30 days prior to first dose of study drug
- Major surgery within 28 days of starting study treatment
- Radiation therapy within 28 days of starting study treatment
- Autoimmune disorders (eg, Crohn's Disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus) and other diseases that compromise or impair the immune system.
- Contra-indications to electroporation: cardiac pacemaker, any previous cardiac rhythm disorder, epilepsy.
- Active and clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness (HIV testing is not required).
- Unstable or serious concurrent medical conditions in the previous 12 months.
- Concurrent active malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix.
- Patients who are pregnant or breastfeeding.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality.
- Patients who are investigational site staff members or patients who are Invectys employees directly involved in the conduct of the trial.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT02301754
Start Date
November 1 2014
End Date
June 1 2018
Last Update
February 26 2019
Active Locations (2)
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1
Hôpital Saint Louis
Paris, France, 75010
2
Hôpital Européen Georges Pompidou
Paris, France, 75015