A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors

NCT05229497 | Active Not Recruiting Phase 1

• 1 other identifier: AK117-201
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

Phase Ib/II open label, multicenter study to evaluate the efficacy and safety of AK112 (anti-PD-1 and VEGF bispecific antibody) combined with AK117#AntiCD47 Antibody# in advanced malignant tumors

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (3)

• Number of patients with Adverse Events (AEs)

  Characterization of incidence, severity and abnormal clinically significant laboratory findings of AEs

  Up to approximately 2 years

• Number of patients experiencing dose-limiting toxicities (DLTs)

  During the first 3 weeks

• Objective Response Rate (ORR)

  Up to approximately 2 years

Secondary Outcomes (5)

• 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 (7)

Phase Ib#Dosage regimen 1#

EXPERIMENTAL

Subjects receive AK112 (20 mg/kg Q3W) + AK117 (30 mg/kg QW)

Drug: AK112; Drug: AK117

Phase Ib#Dosage regimen 2#

EXPERIMENTAL

Subjects receive AK112 (20 mg/kg Q3W) + AK117 (45 mg/kg QW)

Drug: AK112; Drug: AK117

Phase II#Cohort 1#

EXPERIMENTAL

Head and neck squamous cell carcinoma (HNSCC): AK112 (20 mg/kg Q3W)

Drug: AK112

Phase II#Cohort 2#

EXPERIMENTAL

HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)

Drug: AK112; Drug: AK117

Phase II#Cohort 3#

EXPERIMENTAL

HNSCC: AK112 (20 mg/kg Q3W) + AK117 (recommended Phase 2 dose)+Carboplatin/Cisplatin+5-fluorouracil

Drug: AK112; Drug: AK117; Drug: Carboplatin; Drug: Cisplatin; Drug: 5-Fluorouracil

Phase II#Cohort 4 regimen 1#

EXPERIMENTAL

Nasopharyngeal Carcinoma: AK112 (10 mg/kg d1 Q3W) + AK117（recommended Phase 2 dose）+ Cisplatin (80 mg/m2 d1 Q3W)+Gemcitabine (1000 mg/m2 d1, d8 Q3W)

Drug: AK112; Drug: AK117; Drug: Cisplatin; Drug: Gemcitabine

Phase II#Cohort 4 regimen 2#

EXPERIMENTAL

Nasopharyngeal Carcinoma: AK112 (10 mg/kg d1 Q3W) + Cisplatin (100 mg/m2 d1 Q3W)+Gemcitabine (1000 mg/m2 d1, d8 Q3W)

Drug: AK112; Drug: Cisplatin; Drug: Gemcitabine

Interventions

AK112 DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 1#; Phase II#Cohort 2#; Phase II#Cohort 3#; Phase II#Cohort 4 regimen 1#; Phase II#Cohort 4 regimen 2#; Phase Ib#Dosage regimen 1#; Phase Ib#Dosage regimen 2#

AK117 DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 2#; Phase II#Cohort 3#; Phase II#Cohort 4 regimen 1#; Phase Ib#Dosage regimen 1#; Phase Ib#Dosage regimen 2#

Carboplatin DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 3#

Cisplatin DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 3#; Phase II#Cohort 4 regimen 1#; Phase II#Cohort 4 regimen 2#

5-Fluorouracil DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 3#

Gemcitabine DRUG

IV infusion,Specified dose on specified days

Phase II#Cohort 4 regimen 1#; Phase II#Cohort 4 regimen 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 a life expectancy of at least 3 months.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Phase Ib: Histologically or cytologically confirmed selected advanced solid tumor.
• Phase II: Subjects were patients with recurrent/metastatic HNSCC diagnosed histologically and/or cytologically that could not be completely resected surgically and could not be treated with radical simultaneous radiotherapy, or local and or neck recurrence after radical surgery that had progressed with radiotherapy or were unsuitable for radiotherapy.
• Cohort 1 and 2 :
• Recurrent or metastatic HNSCC (non-nasopharyngeal carcinoma) that has not received systemic antitumour therapy for previous recurrent or metastatic stage and has positive PD-L1 expression (CPS ≥ 1); for subjects who have received previous adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent or radical radiotherapy for locally advanced disease, if disease progression occurs after the end of the last chemotherapy session ≥ 6 months, are eligible to participate in this cohort.
• Cohort 3: Recurrent or metastatic HNSCC (non-nasopharyngeal carcinoma) that has not received systemic antitumour therapy for prior recurrent or metastatic stages; for subjects who have received prior adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent, or radical radiotherapy for locally advanced disease, are eligible to participate in this cohort if disease progression occurs ≥6 months after the end of the last chemotherapy treatment.
• Cohort 4: Recurrent or metastatic nasopharyngeal carcinoma that has not received systemic antitumour therapy for prior recurrent or metastatic stages; for subjects who have received prior adjuvant/neoadjuvant chemotherapy for non-metastatic disease with curative intent or radical radiotherapy for locally advanced disease, they are eligible for this cohort if disease progression occurs ≥ 6 months after the end of the last chemotherapy treatment. Note: Subjects with recurrent or residual primary foci after radiotherapy are excluded, and subjects with adenocarcinoma or sarcoma of the nasopharynx are excluded.
• 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)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Interventions

Carboplatin; Cisplatin; Fluorouracil; Gemcitabine

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides

Study Officials

• Xiaozhong Chen, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

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 28, 2022
• First Posted: February 8, 2022
• Study Start: May 4, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CN (1)