A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso
About this trial
This is a multicentre, Phase Ib/II Clinical Study of AK109 and AK104 With or Without Chemotherapy in Second-line Treatment of Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written and signed informed consent
Age ≥ 18 years but ≤ 75 years
ECOG of 0 or 1.
Estimated life expectancy of ≥3 months.
Disqualifiers
Other invasive malignancies within 3 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
Any previous systemic therapy targeting VEGF or anti-VEGFR signaling pathways.
In addition to PD1 or PD-L1,Prior exposure to anti-CTLA-4 antibody, or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (e.g. CD40, CD137, GITR and OX40 etc).
Known history of primary immunodeficiency virus infection.
Trial design
Design model
Parallel
Treatments tested in this trial
AK109
Biological/VaccineSubjects will receive AK109 by intravenous administration.
paclitaxel
DrugSubjects will receive AK109 in combination with paclitaxel.
paclitaxel
DrugSubjects will receive AK104 and AK109 in combination with paclitaxel.
AK104
Biological/VaccineSubjects will receive AK104 by intravenous administration.
Treatment groups
138 Participants
are divided into 2 treatment groupsGroup A: AK109 combined with chemotherapyExperimental treatment 2 interventions
Group B: AK104 and AK109 combined with chemotherapyExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Number of subjects experiencing dose-limiting toxicities (DLTs)
DLTs will be assessed during the first 28 days of treatment and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications .
Time frame
During the first 4 weeks2
Adverse events (AEs)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Time frame
up to 2 years3
Objective response rate (ORR)
The ORR is defined as the proportion of subjects with CR or PR, based on RECIST Version 1.1.
Time frame
up to 2 yearsSecondary outcomes
1
Progression-free survival (PFS)
PFS is defined as the time from the date of first dosing till the first documentation of disease progression (per RECIST v1.1) or death from any cause (whichever occurs first)
Time frame
Up to 2 years2
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1
Time frame
Up to 2 years3
Duration of response (DoR)
Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
Time frame
Up to 2 years4
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Time frame
up to 2 years Source ClinicalTrials.gov