Recruiting NCT04982276
A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AK109, paclitaxel, paclitaxel, AK104.
- Who it may be relevant to
- Registry conditions: Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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 .
Interventions
- Biological AK109
Subjects will receive AK109 by intravenous administration. - Drug paclitaxel
Subjects will receive AK109 in combination with paclitaxel. - Drug paclitaxel
Subjects will receive AK104 and AK109 in combination with paclitaxel. - Biological AK104
Subjects will receive AK104 by intravenous administration.
Primary outcome measures
- Number of subjects experiencing dose-limiting toxicities (DLTs) [Time frame: During the first 4 weeks]
- Adverse events (AEs) [Time frame: up to 2 years]
- Objective response rate (ORR) [Time frame: up to 2 years]
Secondary outcome measures (6)
- Progression-free survival (PFS) [Time frame: Up to 2 years]
- Disease control rate (DCR) [Time frame: Up to 2 years]
- Duration of response (DoR) [Time frame: Up to 2 years]
- Overall survival (OS) [Time frame: up to 2 years]
- Observed pharmacokinetics (PK) exposure of AK109 and AK104 [Time frame: From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104]
- Number of subjects who develop detectable anti-drug antibodies (ADAs) [Time frame: From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104]
Eligibility criteria
Inclusion criteria
- Written and signed informed consent
- Age ≥ 18 years but ≤ 75 years
- ECOG of 0 or 1.
- Estimated life expectancy of ≥3 months.
- Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma.
- At least one measurable lesion per RECIST v1.1.
- Gastric adenocarcinoma or gastroesophageal junction (GEJ) adenocarcinoma with failure of first-line treatment with anti-PD-1/L1 and chemotherapy
- Adequate organ function.
- Have agreed to take effective contraception from the date of signing the informed consent form until 120 days after the last administration.
Exclusion criteria
- 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.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known history of interstitial lung disease.
- Known history of active tuberculosis (TB).
- Central nervous system (CNS) metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease.
- Patients with untreated chronic hepatitis B or HBV DNA exceeding 500IU/mL or active hepatitis C should be excluded. Patients with HCV antibody positive are eligible to participate in the study if the results of HCV RNA test show negative.
- Known history of testing positive for human immunodeficiency virus (HIV).
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- Subjects with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors.
- Pregnant or lactating women.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT04982276 · AK109-201