A Study of AK104 in Subjects With Locally Advanced Unresectable or Metastatic MSI-H/dMMR Solid Tumors

NCT04547101 | Terminated Phase 2

• 1 other identifier: AK104-205
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

It is a single-arm, open-label, multicenter, phase II study to evaluate the safety, efficacy, pharmacokinetics (PK) and immunogenicity of AK104 as a single agent in subjects with previously-treated locally advanced unresectable or metastatic MSI-H or dMMR solid tumors.

Conditions

MSI-H/dMMR Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  ORR is defined as the proportion of subjects with confirmed CR or PR, based on RECIST v1.1.

  Up to 2 years

Secondary Outcomes (7)

• Disease control rate (DCR)

  Up to 2 years

• Duration of response (DoR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

• Adverse events (AEs)

  From first dose of AK104 through to 90 days after last dose of AK104

Study Arms (1)

AK104

EXPERIMENTAL

Drug: AK104

Interventions

AK104 DRUG

AK104，6 mg/kg IV，every 2 weeks (Q2W)

AK104

Eligibility Criteria

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

You may qualify if:

• Have signed written informed consent form voluntarily.
• Male or female, age ≥ 18 years on the day of signing informed consent form.
• ECOG of 0 or 1.
• Estimated life expectancy of ≥3 months.
• Histologically or cytologically documented locally advanced unresectable or metastatic solid tumors.
• Confirmed MSI-H/dMMR status by the central laboratory.
• Have experienced documented disease progression during or after at least first-line therapy.
• Have radiologically measurable disease based on RECIST 1.1.
• 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:

• Prior use of investigational products or devices within 4 weeks prior to C1D1 (Cycle 1 Day 1, the first dose of study drug).
• Presence of active autoimmune disease that have received systematic treatment in the past 2 years; or that is judged to be possibly relapsed or requires planned treatment by investigators.
• Active inflammatory bowel disease or that required treatment (e.g. Crohn's disease, ulcerative colitis or chronic diarrhea).
• Prior use of systematic corticosteroid (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to C1D1.
• Prior exposure to tumor immunotherapy, such as checkpoint inhibitors (eg. anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody), checkpoint agonists or cellular therapy.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Known presence or history of interstitial lung disease.
• History of gastrointestinal perforation and/or fistula within 6 months prior to C1D1.
• Serious infections within 4 weeks prior to C1D1.
• Known presence of active tuberculosis.
• Known untreated chronic hepatitis B or chronic hepatitis B virus DNA exceeding 1000 IU/ mL or active hepatitis C virus.
• Receipt of recent radiotherapy or anti-tumor treatment within 4 weeks prior to C1D1.
• Presence of meningeal metastasis, spinal cord compression, leptomeningeal disease or central nervous system metastasis, with some exceptions.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• Known history of sever hypersensitivity reaction to other monoclonal antibodies.

Sponsors & Collaborators

• Akeso: lead
• Akeso Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Study Officials

• Ruihua Xu, MD

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: April 24, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)