Clinical evaluation of virus therapy for cancer

Phase 1

• Conditions: Colorectal, ovarian, pancreatic, gallbladder and bile duct cancer; MedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-002565-22-SE
• Lead Sponsor: okon Pharma AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-05
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Have histologic or cytologic evidence of colorectal carcinoma (CRC), pancreatic carcinoma (PC), biliary cancer, or epithelial ovarian carcinoma (EOC which may encompass epithelial ovarian, fallopian tube or primary peritoneal carcinoma).
2.Have advanced disease, defined as cancer that is either metastatic or locally advanced, unresectable, and for which radiotherapy or other locoregional therapies are not considered treatment of choice but systemic chemotherapy or no therapy is planned.
3.Have one of the following treatment situations apply:
a)Colorectal carcinoma (CRC), Phase I and Phase IIa only:
i.A patient with refractory or recurrent metastatic CRC who has either received all conventional therapy; or is entering a resting” phase between reasonable conventional treatments.
ii.A patient who is amenable to treatment with LOAd703 plus gemcitabine as a single agent conditioning regimen.
b)Pancreatic cancer
i.A patient with either locally advanced, unresectable or metastatic disease who is eligible to receive first or second line of conventional treatment consisting of gemcitabine and/or nab-paclitaxel.
ii.A patient who is amenable to treatment with LOAd703 as an add-on” to standard-of-care gemcitabine-based or nab-paclitaxel-based regimens or gemcitabine or nab-paclitaxel as single agents.
c)Biliary cancer, Phase I and Phase IIa only
I.A patient with either locally advanced unresectable or metastatic biliary cancer who is either treatment-naïve or has received any number of lines of treatment.
II.Patient who is amenable to treatment with LOAd703 as an add-on” to standard-of-care treatment consisting of gemcitabine combined with other agents (e.g. gemcitabine/low-dose cisplatin, gemcitabine/oxaliplatin, etc) in the first line setting or gemcitabine in a combination regimen or as a single agent in latter lines of treatment.
d)Ovarian Cancer
I.A patient with either epithelial ovarian, fallopian tube or primary peritoneal carcinoma.
II.The patient has either:
i)
ii)Platinum-sensitive relapse (platinum free interval = 6 months) and have previously received at least one line of chemotherapy and not eligible for PARP-inhibitor maintenance after chemotherapy.
iii)Platinum-resistant relapse (platinum free interval < 6 months), who have not received more than two lines of appropriate standard of care and not eligible for bevacizumab. Maintenance treatment does not count as a line of therapy.
iv)The patient has received appropriate therapy with PARP inhibitors if eligible.
II.Amenable to treatment with LOAd703 as an add-on” to standard-of-care (excluding bevacizumab).
4.Have a disease burden that is considered low (i.e. low tumor burden), which is defined on a patient-by-patient basis as per Principal Investigator’s discretion. A rough guideline for defining low tumor burden is that the sum of the product of the bidimensional measurements for all lesions is = 70 cm2.
5.Have a measurable disease by standard imaging techniques per RECIST criteria. Measurable lesions must be outside of any prior radiation field(s), unless disease progression has been documented at that disease site subsequent to radiation.
6.At least one non-irradiated (or irradiated but disease progression documented at the site subsequent to radiation) lesion must be suitable for image-guided intratumoral injection and needle biopsy.
7.Be medically suited to sedation if required during intratumoral injections.
8.Be at leas

Exclusion Criteria

1.Any concurrent treatment that would compromise the study including but not limited to continuous high dose corticosteroids (>0.5mg/kg), lymphodepleting antibodies or cytotoxic agents.
2.Treatment with high dose immune inhibitors including lymphotoxic monoclonal antibodies such as alemtuzumab (Campath), or sirolimus (Rapamune) and its analogs, biological therapy, cytotoxic agents or any investigational agents within 21 days of registration.
3.Ovarian carcinoma patients should not be eligible to PARP inhibitor treatment.
4.Patients on warfarin are not eligible.
5.Women who are pregnant, lactating, or planning to become pregnant during the study period, or women of childbearing potential who are not using acceptable contraceptive methods. A woman is considered of childbearing potential if she is not surgically sterile or is less than 1 year since last menstrual period. Acceptable contraceptive methods are: combined (estrogen and progesterone containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion and vasectomized partner.
6. Men who do not consent to the use of condom during intercourse during study participation.
7.Known active hepatitis B or C infection, or HIV infection.
8.Patients with active, severe autoimmune disease.
9.Uncontrolled intercurrent illness including but not limited to psychiatric illness/social situations that in the opinion of the Investigator would compromise compliance of study requirements or put the patient at unacceptable risk.
10.Other malignancies within the past 2 years (not including basal and squamous cell carcinoma of the skin, localized prostate cancer or in situ cervix carcinoma).
11. Patients must agree to not to vaccinate with living vaccines during participation in the trial.
12.Prior treatment with an adenovirus-based gene therapy
13.Adenovirus-based vaccines (e.g Vaxzevria, known as COVID-19 vaccine Astra Zeneca, J&J Covid-19 vaccine) are prohibited 3 months prior to initiation of study treatment, during treatment and 6 months after the final dose of LOAd703.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified