Blir jo spennende å se utfallet av: Høyring - klinisk utprøving av GMO-legemiddel ONCOS-102 - Legemiddelverket
Interessant hvordan Oncos beskrives i søknaden her:
PART 1 (COUNCIL DECISION 2002/813/EC) (legemiddelverket.no)
“The purpose of the release is to further study the safety, tolerability, pharmacokinetics,
immunogenicity, and antitumour activity of ONCOS-102 as monotherapy and in novel
combination with balstilimab, an anti-PD-1 antibody, in patients with unresectable or
metastatic cutaneous melanoma resistant to anti-PD-(L)1 treatment. It will be studied in a
Phase 2 clinical trial which is an open-label, two-part, dose-exploration and multiple
expansion study to be conducted in multiple centers in several countries.
The study consists of two parts, a Dose-exploration Run-in Part (Part 1) and a Multiple
Expansion Part (Part 2). Safety and efficacy data from both Part 1 and Part 2 will be
assessed.
The primary objective of Part 1 of the trial is to assess the safety and tolerability of ONCOS102 monotherapy at a dose of 1×1012 viral particles (VP; in Cohort 1), the safety and
tolerability of ONCOS-102 at a dose of 3×1011 VP in combination with balstilimab (in
Cohort 2), the safety and tolerability of ONCOS-102 at a dose of 1×1012 VP in combination
with balstilimab (in Cohort 2) if applicable, and to establish the RP2D of ONCOS-102 to be
used in Part 2. The primary objective of Part 2 of the trial is to evaluate the objective
response rate (ORR; by Investigator assessment using RECIST v1.1) at the ONCOS-102
RP2D in both cohorts. Up to approximately 63 evaluable patients are planned to be enrolled
in this study.
In Part 1 of the study, 3 patients will be enrolled into each of Cohort 1 (ONCOS-102 dose
level = 1×1012 VP) and Cohort 2 (ONCOS-102 dose level = 3×1011 VP). After 3 patients in
each cohort have been dosed for a minimum of 2 cycles, a Safety Review Committee (SRC)
will perform a dose-limiting toxicity (DLT) assessment which will guide any dose escalation,
de-escalation, or maintenance of existing ONCOS-102 dose levels. If the ONCOS-102
monotherapy dose is de-escalated to 3×1011 VP, a further 10 patients will be enrolled into
Cohort 1 (dose level de-escalated), and a further 7 patients will be enrolled into Cohort 2
(dose level maintained). If the ONCOS-102 dose is maintained at 1×1012 VP, a further 7
patients will be enrolled into Cohort 1 (dose level maintained), and a further 10 patients will
be enrolled into Cohort 2 (dose level escalated). In Cohort 2, 3+3 design rules will be applied
to proceed with an increased dose level.
In Part 2 of the study, Cohort 1 will be expanded to include up to an additional 10 patients for
a total of up to 20 patients at the chosen dose level. A Simon’s two-stage (minimax) decision
framework will be applied to Cohort 2 to evaluate the combination treatment at ONCOS-102
RP2D. Cohort 2 will initially be expanded to include an additional 8-10 patients, for a total of
18 patients (Simon’s stage 1); if efficacy criteria are met, this will be followed by enrolment
of an additional 19 patients, for a total of 37 patients (Simon’s stage 2).
ONCOS-102 is intended for intratumoural administration; each tumour for injection will be
determined to be injectable by direct visualisation. The injection must be performed by a
suitably trained Investigator or designee with experience in IT drug application in an
approved study site facility.”