All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Antibodies, Bispecific

Immunoglobulins

AK119 and AK104 IV every 2 or every 3 weeks.

AK119 is an anti-CD73 monoclonal antibody.

AK119

AK104 is an anti-PD-1 and CTLA-4 bispecific antibody.

AK104

Ting Liu, MD

Jihui Hao, Doctor

Jihui Hao, PhD

This is a Phase Ib/II Study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 combined with AK104 in tumor patients.

Study of AK119 Combined With AK104 in Patients With Advanced Solid Tumors

A Multicenter, Open-Label, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of AK119 Combined With AK104 in Patients With Advanced Solid Tumors

DLTs will be assessed during the first 3 or 4 weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.

AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.

ORR is defined as the proportion of subjects with CR or PR (based on RECIST Version 1.1).

PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).

DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).

Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.

Time to response (TTR) is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1).

OS defined as the time from the first dose to death from any cause.

The PK parameters include serum concentrations of AK119 and AK104 at different timepoints after study drug administration.

The immunogenicity of AK119 and AK104 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).

Akeso

AK112 is a bispecific monoclonal antibody against VEGF and PD-1.

AK112

Wenming Wu, PhD

This is a Phase Ib/II study to assess the safety, tolerability and preliminary efficacy of AK119 combined with AK112 in patients with advanced solid tumors.

Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors

An Open-label, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability and Antitumor Activity of AK119 in Combination With AK112 in Patients With Advanced Solid Tumors

DLTs will be assessed during the first three weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.

Time to progression (TTP) is defined as the time from the start of the treatment to the documentation of disease progression (based on RECIST Version 1.1).

Subjects will receive escalating doses of AK119 every 2 or 3 weeks.

Subjects will receive AK119 intravenously.

Tianshu Liu

This is Phase 1, Multicenter, Open-Label, Dose-Escalation and Dose-Exploration Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of AK119 (Anti-CD73) in Subjects with Advanced or Metastatic Solid Tumors.

Study of AK119 in Subjects With Advanced Solid Tumors

A Phase I, Multicenter, Open-Label, Dose-escalation and Dose-exploration Study to Evaluate the Safety, Pharmacokinetics, and Anti-tumor Activity of of AK119 (CD73) in Subjects With Advanced Solid Tumors

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.

DLTs will be assessed during the first 4 weeks of treatment for dose-escalation phase and first 3 weeks for dose-exploration phase. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.

Serum PK concentration of AK119 in individual subjects at different time points after AK119 administration.

The immunogenicity of AK119 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).

ORR is defined as the proportion of subjects with confirmed CR or confirmed PR.

DCR is defined as the proportion of subjects with CR, PR, or SD.

PFS is defined as the time from the start of treatment with AK119 until the first documentation of disease progression or death due to any cause, whichever occurs first.

Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Antineoplastic Agents

Micronutrients

Bone Density Conservation Agents

Hematinics

Vitamins

Irinotecan

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Calcium

Calcium, Dietary

Hormones

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folinic Acid

Folate

Vitamin B9

Subjects will receive AK119 plus AK112 via intravenously (IV) Q2W, up to 2 years

Subjects will receive AK119 and AK112 plus mFOLFOX6 via intravenously (IV)Q2W, up to 12 cycles. Afterward, AK119 and AK112 will continue to be treated up to 2 years.

Subjects will receive AK119 and AK112 plus FOLFIRI via intravenously (IV)Q2W, up to 12 cycles. Afterward, AK119 and AK112 will continue to be treated up to 2 years.

AK119 IV every 2 weeks.intravenous infusion

AK112 IV every 2 weeks.intravenous infusion

Oxaliplatin: 85mg/m2, intravenous infusion

Irinotecan 180mg/m2, intravenous infusion

Calcium folinate: 400mg/m2, intravenous infusion

Calcium folinate

Fluorouracil 400mg/m2, intravenous injection

Zhifang Yao, MD

Yanqiao Zhang, PhD

This is a phase Ib/II clinical study on AK119 and AK112 combined with or without chemotherapy in advanced microsatellite stabilized (pMMR/MSS) colorectal cancer

The study included the screening period (no more than 28 days after the subject signed the informed consent form to the first medication), the treatment period (until the investigator assessed that there was no clinical benefit, intolerable toxicity or withdrew the informed consent, whichever occurred first) and the follow-up period (including safety follow-up, disease progress follow-up and survival follow-up). Subjects will be screened and evaluated within 28 days before the first medication to determine whether they meet the study conditions. During the screening period, tumor samples of the subjects need to be collected. Subjects who meet the study conditions will be treated according to the study medication plan until the following conditions occur: the investigator judges that the subject cannot continue to benefit, there is intolerable toxicity, there is a concomitant disease that affects further treatment, the investigator decides, the subject withdraws his informed consent or the treatment needs to be terminated for other reasons specified in the plan (whichever occurs first). The investigator regularly evaluated the tumor response of all subjects according to RECIST 1.1 standard. Subjects were evaluated once every 6 weeks (± 7 days) within 54 weeks after enrollment, and then once every 9 weeks (± 7 days). For subjects undergoing treatment, their clinical decisions are based on the tumor response evaluated by the researchers

Study of AK119 and AK 112 With or Without Chemotherapy for Colorectal Cancer Patients

A Phase Ib/II Study of AK112 and AK119 in Combination With or Without Chemotherapy in the Treatment of Patients With Advanced Microsatellite Stabilized (pMMR/MSS) Colorectal Cancer

ORR is defined as the proportion of subjects with confirmed CR or confirmed PR

Phase II clinical study recommended dose (RP2D) of AK119 and AK112 combined with or without chemotherapy

PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1)

DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first

TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1)

OS defined as the time from the first dose to death from any cause

The PK parameters include serum concentrations of AK119 and AK112 at different timepoints after study drug administration.

The immunogenicity of AK119 and AK112 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).

Correlation between the expression level of PD-L1 and CD73 biomarkers and efficacy ORR, PFS and OS

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Amino Acids

Carboplatin

Pemetrexed

Mitogens

Tyrosine Kinase Inhibitors

Folic Acid Antagonists

Tyrosine

Subjects will receive AK119 plus AK112 via intravenously (IV) Q3W, up to 2 years.

Subjects will receive AK119 and AK112 plus pemetrexed and carboplatin via intravenously (IV) Q3W, up to 4 cycles. Afterward, AK119 and AK112 plus pemetrexed will continue to be treated up to 2 years.

Subjects will receive AK112 monotherapy via intravenously (IV) Q3W, up to 2 years.

Yilong Wu, PhD

This is a phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 and AK112 With or Without Chemotherapy for NSCLC patients.

Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients

A Multicenter, Open-Label, Phase Ib/II Study of AK119 and AK112 With or Without Chemotherapy in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment

DLTs will be assessed during the first 3 weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.

DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.

TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of AK119 Combined With AK104 in Patients With Advanced Solid Tumors	NCT05559541	Solid Tumor, Ad...	AK119 AK104	18 Years -	Akeso
Study of AK119 Combined With AK112 in Patients With Advanced Solid Tumors	NCT05689853	Solid Tumor, Ad...	AK119 AK112	18 Years - 75 Years	Akeso
Study of AK119 in Subjects With Advanced Solid Tumors	NCT05173792	Solid Tumor	AK119	18 Years -	Akeso
Study of AK119 Combined With AK104 in Patients With Advanced Solid Tumors	NCT05559541	Solid Tumor, Ad...	AK119 AK104	18 Years -	Akeso
Study of AK119 and AK 112 With or Without Chemotherapy for Colorectal Cancer Patients	NCT05846867	Colorectal Canc...	AK119 AK112 Oxaliplatin Irinotecan Calcium folinat... Fluorouracil	18 Years -	Akeso
Study of AK119 in Subjects With Advanced Solid Tumors	NCT05173792	Solid Tumor	AK119	18 Years -	Akeso
Study of AK119 and AK 112 With or Without Chemotherapy for Colorectal Cancer Patients	NCT05846867	Colorectal Canc...	AK119 AK112 Oxaliplatin Irinotecan Calcium folinat... Fluorouracil	18 Years -	Akeso
Study of AK119 and AK 112 With or Without Chemotherapy for Colorectal Cancer Patients	NCT05846867	Colorectal Canc...	AK119 AK112 Oxaliplatin Irinotecan Calcium folinat... Fluorouracil	18 Years -	Akeso
Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients	NCT05636267	NSCLC	AK119 AK112 Pemetrexed Carboplatin	18 Years - 75 Years	Akeso

Spots Global Cancer Trial Database for ak119

Every month we try and update this database with for ak119 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 ak119

Every month we try and update this database with for ak119 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 ak119 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.