Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphosarcoma

AK117 monotherapy intravenous (IV) infusion - Weekly doses

An intravenous (IV) infusion of AK117 as monotherapy. All subjects will receive 4 weekly infusions (Days 1, 8, 15, and 22) of AK117 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal

AK117

Jiong Wu, MD

This is a multicenter, open label, single arm, Phase 1，dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacodynamics, PK, immunogenicity, and preliminary antitumor activity of AK117 administered intravenously to adult subjects with relapsed/refractory advanced or metastatic solid tumors or lymphomas.

The study comprises a dose escalation phase and a dose expansion phase. The phases will be conducted sequentially. Approximately 162 subjects will be enrolled in this study.

A Phase 1 Dose Escalation and Expansion Study of AK117

A Multicenter, Phase 1, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 in Subjects With Advanced Solid Tumors or Lymphomas

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 21 days of treatment for dose-escalation phase and 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 .

ORR defined as the proportion of subjects who achieves a best overall response of CR or PR, assessed by Investigator per RECIST Version 1.1 for solid tumor or the Lugano 2014 Classification for lymphoma

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

The endpoints for assessment of PK of AK104 include serum concentrations of AK117 at different timepoints after AK117 administration.

The immunogenicity of AK117 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).

Akeso

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Azacitidine

Immunoglobulins

Antimetabolites

Enzyme Inhibitors

Phase Ib: Subjects will receive different doses of A117 in combination with azacitidine 75 mg/m2 subcutaneous daily for 7 days of a 28 day cycle;

Phase II: Subjects will receive AK117 at the recommended Phase 2 dose in combination with azacitidine 75 mg/m2 subcutaneous daily for 7 days of a 28-day cycle.

Subjects receive Azacitidine subcutaneously.

Weifeng Song, PhD

Jie Jin, MD

This is a open label, phase Ib/II study. All patients are diagnosed with AML, Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine in subjects with AML.

A Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia

A Phase Ib/II Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia

Number of participants achieving a complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2017 criteria.

The rate of CR MRD- is the percentage of participants who achieve a CR MRD- as defined by investigators based on ELN 2017 criteria.

The DoCR is measured from the time the assessment criteria are first met for CR (including CR MRD- and CR MRD+/unk) until the first date of AML relapse or death.

The OS is measured from the date of treatment to the date of death from any cause.

The EFS is defined as time from the date of treatment to the earliest date of documented relapse from complete remission (CR), treatment failure , or death from any cause.

Serum concentrations of AK117 in individual subjects at different time points after AK117 administration.

Number of subjects with detectable anti-drug antibodies (ADA).

Venetoclax

Phase Ib: Subjects will receive: A117: different doses on every 2 weeks, azacitidine: 75 mg/m\^2 on Days 1-7 each cycle, venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter;

Phase II: Subjects will receive: AK117: the recommended Phase 2 dose (RP2D) on every two weeks, azacitidine: 75 mg/m\^2 on Days 1-7 each cycle, venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter.

Phase II: Subjects will receive: placebo: the recommended Phase 2 dose (RP2D) on every two weeks, azacitidine: 75 mg/m\^2 on Days 1-7 each cycle, venetoclax: 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, 400 mg on Cycle 1 Day 3 and daily thereafter.

Subjects receive azacitidine subcutaneously.

Placebo

Jie Yang, MD

Jianxiang Wang

This is a phase 1b/2 study. All patients are diagnosed with Acute Myeloid Leukemia (AML), Eastern Cooperative Oncology Group (ECOG) performance status 0-3. The purpose of this study is to evaluate the safety and efficacy of AK117 + azacitidine + venetoclax in subjects with AML.

A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia

A Phase 1b/2 Study of AK117 (Anti-CD47 Antibody) in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia

Any untoward medical occurrence in a subject within the first cycle, considered related to the study treatment

Any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment

The proportion of subjects achieving complete remission (CR) , complete remission with partial hematologic recovery (CRh) or complete remission with incomplete hematologic recovery (CRi) per European LeukemiaNet (ELN) 2022 criteria

The proportion of subjects with recorded response per European LeukemiaNet (ELN) 2022

Time from cycle 1 day 1(C1D1) to the first recorded response

Time from C1D1 to the first recorded CR, CRh or CRi

Time from the first recorded response until disease progression, relapse, or death due to any cause, whichever occurs first

Time from the first recorded CR, CRh or CRi until disease progression, relapse, or death due to any cause, whichever occurs first

The proportion of subjects achieving CR, CRh or CRi with MRD-negative status per ELN 2022 criteria.

Time from C1D1 until disease progression, relapse, or death due to any cause, whichever occurs first

Maximal serum concentrations of AK117 in individual subjects at different time points after AK117 administration

Number of subjects with detectable anti-drug antibodies

CD47 occupancy rate on peripheral blood T cells and red blood cells before and after AK117 administration

Paclitaxel

Docetaxel

Albumin-Bound Paclitaxel

Oxaliplatin

Fluorouracil

Irinotecan

Capecitabine

Cisplatin

Antibodies, Bispecific

Tubulin Modulators

Antimitotic Agents

Topoisomerase I Inhibitors

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

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

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

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

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

IV infusion,Specified dose on specified days

AK104

Capecitabine tablets

5-FU

Weifeng Song, MD

Liwei Wang

Liwei Wang, MD

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

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

A Phase Ib/II Study of AK104#PD-1 / CTLA-4 Bispecific Antibody# and AK117#Anti-CD47 Antibody# in Combination With or Without Chemotherapy in Advanced Malignant Tumors

The endpoints for assessment of PK include serum concentrations of AK117 and AK104 at different timepoints after study drug administration.

The immunogenicity of AK117 and AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs).

Symptoms and General Pathology

Syndrome

Preleukemia

Myelodysplastic Syndromes

Bone Marrow Diseases

Precancerous Conditions

Subjects receive AK117 (dose 1) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously

Subjects receive AK117 (dose 2) intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously

Subjects receive placebo intravenously, in combination with azacitidine (75 mg/m2, D1-7, Q4W) subcutaneously

Zhijian Xiao

This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of AK117 or placebo, combined with azacitidine in patients with newly diagnosed higher-risk myelodysplastic syndromes (HR-MDS).

A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes

A Randomized, Double-blind, Placebo-controlled, Multicenter Phase 2 Study of AK117/Placebo in Combination With Azacitidine in Patients With Newly Diagnosed Higher-risk Myelodysplastic Syndromes

CRR is defined as the proportion of subjects with complete remission (CR) per International Working Group (IWG) 2023 criteria

The proportion of subjects with recorded response per IWG 2023

Time from the randomization to the first recorded response

Time from the randomization to the first recorded CR

Time from the first recorded response until disease relapse or progression or death due to any cause, whichever occurs first

Time from the first recorded CR until disease relapse or progression or death due to any cause, whichever occurs first

Time from randomization until transformation to AML or death due to any cause, whichever occurs first

The time from randomization until death due to any cause

An AE is any untoward medical occurrence in a subject, temporally associated with the use of study treatment, whether or not considered related to the study treatment

Serum concentrations of AK117 in individual subjects at different time points after AK117 administration

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Subjects receive AK117 and AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.

Subjects receive AK117 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.

Subjects receive AK112 Plus Nab-Paclitaxel/ Paclitaxel until disease progression or unacceptable toxicity.

AK117 at a dose of 45mg/kg via intravenous (IV) infusion on Days 1,8 ,15 and 22of each 28-day cycle until disease progression or unacceptable toxicity

AK112 at a dose of 20mg/kg via intravenous (IV) infusion on Days 1and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

AK112

Nab-Paclitaxel at a starting dose of 100 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

Nab paclitaxel

Paclitaxel at a starting dose of 90 milligrams per square meter via IV infusion on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.

paclitaxel

Quchang Ouyang, MD

Tienan Yi, PD

This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK117/AK112 administered with chemotherapy in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).

A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer

A Phase II Study of AK117/AK112 in Combination With Chemotherapy for Patients With Previously Untreated Metastatic Triple-Negative Breast Cancer

ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1

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

Disease control rate (DCR) is defined as the proportion of subjects with CR, PR, or stable disease(SD) based on RECIST V1.1

DOR is defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause, whichever occurred first

TTR is defined for participants who had an objective response as the time from the start of treatment to the first occurrence of a documented unconfirmed response (CR or PR) .

PFS is defined as the time from the start of treatment till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).

Overall survival is defined as the time from the start of treatment until death due to any cause.

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Micronutrients

Hematinics

Vitamins

Leucovorin

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

AK112+AK117+XELOX

AK112 and AK117 and XELOX(Oxaliplatin 130 mg/sqm iv day 1, Capecitabine via oral, the total daily dose was 2000mg/sqm, day1-14)

If no progression occurs during AK112 plus AK117 plus XELOX, patients will receive maintenance capecitabine plus AK112 plus AK117 at the same dose used at the last cycle of the induction treatment. Capecitabine plus AK112 plus AK117 will be repeated every 3 weeks until disease progression, unacceptable toxicity or patient's refusal.

AK112+AK117+FOLFOXIRI

AK112 and AK117 and FOLFOXIRI(Irinotecan 150-165 mg/sqm iv day 1, Oxaliplatin 85 mg/sqm iv day 1, Leucovorin(LV) 400 mg/sqm iv day 1, 5-fluorouracil(5-FU) 2400-2800 mg/sqm 48 h-continuous infusion, starting on day 1)

If no progression occurs during AK112 plus AK117 plus FOLFOXIRI, patients will receive maintenance 5-FU/LV plus AK112 plus AK117 at the same dose used at the last cycle of the induction treatment. 5-FU/LV plus AK112 plus AK117 will be repeated biweekly until disease progression, unacceptable toxicity or patient's refusal.

AK112+Chemotherapy(Decided by Chemotherapy Regimen Selection Stage)

AK112 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage)

AK112+AK117+Chemotherapy(Decided by Chemotherapy Regimen Selection Stage)

AK112 and AK117 and XELOX or FOLFOXIRI(the same dosage, frequency and duration with Chemotherapy Regimen Selection Stage)

Subjects receive AK112 until disease progression or unacceptable toxicity

AK112 (until disease progression, unacceptable toxicity or patient's refusal)

Subjects receive AK117 and AK112 until disease progression or unacceptable toxicity

AK112 and AK117 ( until disease progression, unacceptable toxicity or patient's refusal)

AK112 via intravenous (IV) infusion until disease progression or unacceptable toxicity

AK117 via intravenous (IV) infusion until disease progression or unacceptable toxicity

Capecitabine via oral,The total daily dose was 2000mg/sqm, Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days

5-fluorouracil

Xufang Yu, MD

This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of AK112 with or without AK117 in participants with metastatic colorectal cancer who are not suitable for surgery.

A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer

A Phase II Study of AK112 With or Without AK117 for Patients With Metastatic Colorectal Cancer

DOR is defined for participants who had an objective response as the time from the first occurrence of a documented confirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause,whichever occurred first

PFS 2 is defined as the time from the start of treatment till the second documentation of disease progression (per RECIST v1.1 criteria) assessed by the investigator or death due to any cause (whichever occurs first).

Carboplatin

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

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

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

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

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

5-Fluorouracil

Xiaozhong Chen, MD

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1 Dose Escalation and Expansion Study of AK117	NCT04728334	Neoplasms Malig...	AK117	18 Years - 75 Years	Akeso
A Trial of AK117 (Anti-CD47 Antibody) in Patients With Acute Myeloid Leukemia	NCT04980885	Acute Myeloid L...	AK117 Azacitidine	18 Years -	Akeso
A Study of AK117 in Combination With Azactidine Plus Venetoclax in Patients With Acute Myeloid Leukemia	NCT06387420	ACUTE MYELOID L...	AK117 Azacitidine Venetoclax Placebo	18 Years -	Akeso
A Phase Ib/II Study of AK104 and AK117 in Combination With or Without Chemotherapy in Advanced Malignant Tumors	NCT05235542	Advanced Malign...	AK104 AK117 Capecitabine ta... Oxaliplatin Cisplatin Paclitaxel Irinotecan Docetaxel 5-FU	18 Years - 75 Years	Akeso
A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes	NCT06196203	Higher-risk Mye...	AK117 Placebo Azacitidine	18 Years -	Akeso
A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer	NCT05227664	Metastatic Trip... Locally Advance...	AK117 AK112 Nab paclitaxel paclitaxel	18 Years - 75 Years	Akeso
A Phase 1 Dose Escalation and Expansion Study of AK117	NCT04728334	Neoplasms Malig...	AK117	18 Years - 75 Years	Akeso
A Study of AK112 With or Without AK117 in Metastatic Colorectal Cancer	NCT05382442	Metastatic Colo...	AK112 AK117 Oxaliplatin Capecitabine Irinotecan Leucovorin 5-fluorouracil	18 Years - 75 Years	Akeso
A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors	NCT05229497	Advanced Malign...	AK112 AK117 Carboplatin Cisplatin 5-Fluorouracil	18 Years - 75 Years	Akeso
A Study of AK117 in Combination With Azacitidine in Patients With Myelodysplastic Syndromes	NCT06196203	Higher-risk Mye...	AK117 Placebo Azacitidine	18 Years -	Akeso
A Study of AK117/AK112 in Metastatic Triple-Negative Breast Cancer	NCT05227664	Metastatic Trip... Locally Advance...	AK117 AK112 Nab paclitaxel paclitaxel	18 Years - 75 Years	Akeso
A Study of AK112 in Advanced Malignant Tumors	NCT05214482	Advanced Malign...	AK112 AK117 Chemotherapy	18 Years - 75 Years	Akeso
A Phase Ib/II Study of AK112 in Combination With AK117 in Advanced Malignant Tumors	NCT05229497	Advanced Malign...	AK112 AK117 Carboplatin Cisplatin 5-Fluorouracil	18 Years - 75 Years	Akeso

Spots Global Cancer Trial Database for ak117

Every month we try and update this database with for ak117 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 ak117

Every month we try and update this database with for ak117 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 ak117 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.