A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors

NCT05235542 | Unknown Phase 1

• 1 other identifier: AK117-204
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) and AK117#AntiCD47 Antibody# combined with or without chemotherapy in advanced malignant tumors

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (2)

• Number of patients with Adverse Events (AEs)

  Up to approximately 2 years

• Objective Response Rate (ORR)

  Up to approximately 2 years

Secondary Outcomes (8)

• Disease control rate (DCR)

  Up to approximately 2 years

• Duration of Response (DoR)

  Up to approximately 2 years

• Time to response (TTR)

  Up to approximately 2 years

• Progression free survival (PFS)

  Up to approximately 2 years

• Overall survival (OS)

  Up to approximately 2 years

Study Arms (5)

Phase Ib#Dosage regimen 1#

EXPERIMENTAL

Subjects receive AK104 plus AK117 every 3- week cycle (Q3W) until progression

Drug: AK104; Drug: AK117

Phase Ib#Dosage regimen 2#

EXPERIMENTAL

Subjects receive AK104 plus AK117 every 6- week cycle (Q6W) until progression

Drug: AK104; Drug: AK117

Phase II#Cohort 1#

EXPERIMENTAL

Gastric Cancer or Gastroesophageal Junction Cancer: AK104 + XELOX (Oxaliplatin + Capecitabine)+AK117 every 3- week cycle (Q3W) until progression

Drug: AK104; Drug: AK117; Drug: Capecitabine tablets; Drug: Oxaliplatin

Phase II#Cohort 2#

EXPERIMENTAL

Esophageal squamous cell cancer: AK104 + 5-FU/Paclitaxel+Cisplatin± AK117 every 3- week cycle (Q3W) until progression

Drug: AK104; Drug: AK117; Drug: Cisplatin; Drug: Paclitaxel; Drug: 5-FU

Phase II#Cohort 3#

EXPERIMENTAL

Gastric Cancer or Gastroesophageal Junction Cancer or Esophageal squamous cell cancer: AK117 +Paclitaxel/Docetaxel/Irinotecan every 3- or 4- week cycle (Q3W or Q4W) until progression

Drug: AK117; Drug: Paclitaxel; Drug: Irinotecan; Drug: Docetaxel

Interventions

AK104 DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 1#; Phase II#Cohort 2#; Phase Ib#Dosage regimen 1#; Phase Ib#Dosage regimen 2#

AK117 DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 1#; Phase II#Cohort 2#; Phase II#Cohort 3#; Phase Ib#Dosage regimen 1#; Phase Ib#Dosage regimen 2#

Capecitabine tablets DRUG

Oral,Specified dose on specified days

Phase II#Cohort 1#

Oxaliplatin DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 1#

Cisplatin DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 2#

Paclitaxel DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 2#; Phase II#Cohort 3#

Irinotecan DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 3#

Docetaxel DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 3#

5-FU DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 2#

Eligibility Criteria

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

You may qualify if:

• to 75 years old.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Have a life expectancy of at least 3 months.
• Phase Ib: Histologically or cytologically confirmed advanced solid tumor.
• Phase II: Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma or Esophageal squamous cell carcinoma.
• Have at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator.
• Has adequate organ function.

You may not qualify if:

• Undergone major surgery within 30 days prior to the first dose of study treatment.
• Active central nervous system (CNS) metastases.
• History of active autoimmune disease that has required systemic treatment in the past 2 years (i.e.,corticosteroids or immunosuppressive drugs).
• Active Hepatitis B or Hepatitis C.
• Received previous immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy and other treatments targeting the mechanism of tumor immunity.
• History of severe bleeding tendency or coagulation disorder.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

Shanghai Renji Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Capecitabine; Oxaliplatin; Cisplatin; Paclitaxel; Irinotecan; Docetaxel; Fluorouracil

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Camptothecin; Alkaloids

Study Officials

• Liwei Wang, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weifeng Song, MD

CONTACT

+86(0760)89873999; clinicaltrials@akesobio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: February 11, 2022
• Study Start: July 12, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: August 11, 2022

Record last verified: 2022-08

Locations

CN (1)