A Study of AK109 and AK104 in Advanced Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma

NCT04982276 | Recruiting Phase 1

• 1 other identifier: AK109-201
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• 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 .

  During the first 4 weeks

• 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.

  up to 2 years

• Objective response rate (ORR)

  The ORR is defined as the proportion of subjects with CR or PR, based on RECIST Version 1.1.

  up to 2 years

Secondary Outcomes (6)

• Progression-free survival (PFS)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

• Overall survival (OS)

  up to 2 years

• Observed pharmacokinetics (PK) exposure of AK109 and AK104

  From first dose of AK109 and AK104 through 90 days after last dose of AK109 and AK104

Study Arms (2)

AK109 combined with chemotherapy

EXPERIMENTAL

AK109 combined with paclitaxel, iv, every 3 weeks

Biological: AK109; Drug: paclitaxel

AK104 and AK109 combined with chemotherapy

EXPERIMENTAL

AK104 combined with AK109 and paclitaxel, iv, every 3 weeks

Biological: AK109; Drug: paclitaxel; Biological: AK104

Interventions

AK109 BIOLOGICAL

Subjects will receive AK109 by intravenous administration.

AK104 and AK109 combined with chemotherapy; AK109 combined with chemotherapy

paclitaxel DRUG

Subjects will receive AK109 in combination with paclitaxel.

AK109 combined with chemotherapy

AK104 BIOLOGICAL

Subjects will receive AK104 by intravenous administration.

AK104 and AK109 combined with chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Lin Shen, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Liu, MD

CONTACT

+86 (0760) 8987 3999; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 29, 2021
• Study Start: August 23, 2021
• Primary Completion: December 30, 2025
• Study Completion (Estimated): January 31, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)