Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Carboplatin

Pemetrexed

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Subjects will receive AK112 Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles. Afterward, AK112 Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.

Subjects will receive Placebo Plus Pemetrexed and Carboplatin via intravenous infusion (IV) Q3W, up to 4 cycles in treatment periods per the randomization schedule. Afterward, Placebo Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.

AK112 Injection

Placebo Injection

Lori Styles, MD

A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Progressed on or Following Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (HARMONi)

The trial will be performed as a randomized, Double-Blind, Multicenter trial to compare Ivonescimab (SMT112 /AK112) Plus Pemetrexed and Carboplatin to Placebo Plus Pemetrexed and Carboplatin in Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring. Approximately 420 subjects will be randomized to two treatment arms at the ratio of 1:1. Each enrolled subject will receive an intravenous infusion of the Ivonescimab (SMT112 /AK112)/Placebo Plus Pemetrexed and Carboplatin (Q3W,up to 4 cycles) in treatment periods per the randomization schedule. Afterward, Ivonescimab (SMT112 /AK112)/ Placebo Plus Pemetrexed will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W) up to 2 years.

Phase III Study of AK112 for NSCLC Patients

A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment

Progression-free survival (PFS) assessed by IRC per RECIST v1.1 in the ITT population.

Overall Survival (OS) in the ITT population

Efficacy measures such as overall response rate (ORR) and duration of response (DoR), which is the proportion of subjects with CR or PR by IRRC based on RECIST v1.1

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.

The endpoints for assessment of PK of AK112 include serum concentrations of AK112 at different timepoints after AK112 administration

The immunogenicity of AK112 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs)

Duration of response (DoR) which is the proportion of subjects with CR or PR by IRRC based on RECIST v1.1

Akeso

Summit Therapeutics

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Oxaliplatin

Tegafur

Capecitabine

Antimetabolites

Biological: Cadonilimab (AK104) 10mg/kg or 15mg/kg or 6mg/kg Q6W iv D8 (dose choosing depends on the outcome of the dose climb stage) Biological: Ivonescimab (AK112): 20mg/kg Q3W iv D1 Drug:SOX or XELOX SOX: Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Tegafur (40 mg/m2, p.o., Bid, Q3W, for day 1 to day 14 per cycle) XELOX: Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+Capecitabine(1000 mg/m2, p.o., Bid, Q3W, for day 1 to day 14 per cycle)

Subjects will receive AK104 by intravenous administration

Cadonilimab

Subjects will receive AK112 by intravenous administration

Ivonescimab

Subjects will receive AK104 and AK112 in combination with XELOX(oxaliplatin and capecitabine)

XELOX

Subjects will receive AK104 and AK112 in combination withSOX(oxaliplatin and Tegafur)

yanqiao zhang, phD

The goal of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and anti-tumor activities of cadonilimab in combination with Ivonescimab plus chemotherapy as first-line therapy in adult subjects with HER2 negative、advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.

The study consists of a dose escalation and expansion phase to determine the recommended Phase 2 dose (RP2D) for AK104 in combination with AK112 and SOX/XELOX, and a dose confirmation phase which will further characterize the treatment of AK104 in combination at the RP2D.

AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer

A Phase II, Single Arm, Single Center Study of Cadonilimab(AK104) in Combination With Ivonescimab(AK112) Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced Gastric (G) or Gastroesophageal Junction (GEJ) Cancer

Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.

Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.

Defined as the time between signing the informed consent form to death due to various causes.

Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.

Defined as the time from response(when CR or PR is first diagnosed) to disease progression or death due to any cause.

Use NCI-CTCAE version 5.0 for classification and grading.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase III Study of AK112 for NSCLC Patients	NCT06396065	Non-Squamous No...	AK112 Injection Placebo Injecti...	18 Years -	Summit Therapeutics
AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer	NCT06196697	Gastric Adenoca... Gastroesophagea...	Cadonilimab Ivonescimab XELOX SOX	18 Years - 75 Years	Harbin Medical University

Spots Global Cancer Trial Database for ivonescimab

Every month we try and update this database with for ivonescimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ivonescimab

Every month we try and update this database with for ivonescimab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ivonescimab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.