A Study of AK104/Placebo Plus AK109/Placebo And Paclitaxel in Gastric or Gastroesophageal Junction Adenocarcinoma

NCT06341335 | Recruiting Phase 3

• 1 other identifier: AK109-301
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, multicenter, double-blind, phase 3 study will evaluate the efficacy and safety of the combination of cadonilimab (AK104) and pulocimab (AK109) and paclitaxel compared with paclitaxel in patients with advanced gastric or gastroesophageal junction adenocarcinoma who failed first-line immunochemotherapy.

Conditions

Gastric and Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS) assessed by blinded independent central review (BICR)

  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).

  Up to 2 years

• Overall survival (OS)

  OS is defined as the time from randomization to death due to any cause.

  Up to 2 years

Secondary Outcomes (4)

• Progression-free survival (PFS) assessed by investigator

  Up to 2 years

• Objective Response Rate (ORR)

  Up to 2 years

• Duration of Response (DoR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

Study Arms (2)

Cadonilimab in combination with pulocimab and paclitaxel

EXPERIMENTAL

Cadonilimab (AK104) in combination with pulocimab (AK109) and paclitaxel, iv, every 3 weeks

Drug: cadonilimab; Drug: pulocimab; Drug: paclitaxel

Placebo in combination with paclitaxel

ACTIVE COMPARATOR

Placebo in combination with Paclitaxel, iv, every 3 weeks

Drug: paclitaxel; Drug: placebo

Interventions

cadonilimab DRUG

iv, q3w

Also known as: AK104

Cadonilimab in combination with pulocimab and paclitaxel

pulocimab DRUG

iv, q3w

Also known as: AK109

Cadonilimab in combination with pulocimab and paclitaxel

paclitaxel DRUG

iv, q3w

Cadonilimab in combination with pulocimab and paclitaxel; Placebo in combination with paclitaxel

placebo DRUG

iv, q3w

Placebo in combination with paclitaxel

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• Age ≥ 18 years and ≤ 75 years
• Histologically or cytologically documented advanced unresectable or metastatic gastric adenocarcinoma or gastroesophageal Junction (GEJ) adenocarcinoma.
• Failed first-line treatment with PD-(L)1 monoclonal antibody and standard chemotherapy
• At least one measurable disease based on RECIST v1.1
• ECOG status of 0 or 1
• Estimated survival ≥ 3 months
• Adequate organ function per protocol-defined criteria
• Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 120 days following the last dose of study treatment

You may not qualify if:

• Mixed gastric or gastroesophageal Junction cancer containing other pathological components than adenocarcinoma
• HER2-positive
• Known other invasive malignancies within 3 years
• Subjects who are currently participating in other interventional study
• Received prior systemic anti-tumour therapy within 4 weeks before randomization
• Previous systemic treatment with taxane within 6 months before randomization
• Previous systemic treatment targeting VEGF or anti-VEGFR signaling pathways
• In addition to anti-PD-(L)1 monoclonal antibody, prior exposure to other immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy or other therapy that targets anti-tumor immune mechanisms
• History of immune-related adverse effects leading to recommendation against reintroduction of immunotherapy or any condition dependency on systemic therapy with glucocorticoids or immunosuppressive agents within 14 days prior to randomization
• History of severe infection within 4 weeks prior to randomization
• Presence of central nervous system metastases, leptomeningeal metastases, or spinal cord compression
• Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage
• History or presence of a serious hemorrhage or known bleeding tendency within 2 months before randomization
• Major surgical procedure or serious trauma within 28 days prior to randomization
• History of interstitial lung disease or noninfectious pneumonitis

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Peking University Cancer Hospital & Institute

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

• Xiaotian Zhang, MD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Liu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: March 26, 2024
• First Posted: April 2, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 24, 2024

Record last verified: 2024-06

Locations

CN (1)