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A Phase 1 Dose Escalation and Expansion Study of AK117 | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT04728334•Akeso

View on ClinicalTrials.gov

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All Subjects
•1. Able to provide written and signed informed consent and any locally required authorization obtained from the subject/legal representative, which must be obtained prior to performing any protocol related procedures.
•2. Men or women aged ≥18 years and ≤75 at the time of study entry.
•3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
•4. Life expectancy ≥12 weeks.
•5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.
•6. Subjects must provide the tumor tissue samples after the diagnosis of solid tumor or lymphoma.
•7. Adequate organ function.
•8. Subjects with Solid Tumors：Subjects must have a histologically or cytologically confirmed advanced solid tumor that is refractory or relapsed to the current standard therapies, or for which no effective standard therapy is available. Subject must have at least 1 measurable lesion according to RECIST v1.1.
•9. Subjects with Lymphomas：Subjects must have histologically confirmed non-Hodgkin lymphoma(NHL), which may include transformed lymphoma, relapsed or refractory to autologous hematopoietic stem cell transplantation, or at least 2 lines of prior chemotherapy. Subjects must have disease that is measurable or assessable for response as per Lugano Classification 2014.

Exclusion Criteria

•All Subjects
•1. Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow up period of an interventional study.
•2. Prior malignancy active within the previous 3 years except for the tumor for which a subject is enrolled in the study, and locally curable cancers that have been apparently cured.
•3. Receipt: The last cycle of anticancer therapy within 3 weeks prior to the first dose of investigational product; Anticancer small molecule targeted agent, palliative local treatment for non-target lesions, non-specific immunomodulatory therapy within 2 weeks prior to the first dose of investigational product; Chinese medicines with anti-tumor indications within 1 week prior to the first dose of investigational product; Any major surgery within 4 weeks; RBC infusion within 3 months.
•4. Metastasis or infiltration of brainstem and meninges;Metastasis or compression of the spinal cord; Active brain/central nervous system (CNS) metastases.
•5. Subjects with clinical symptoms or repeated drainage of pleural effusion, pericardial effusion or ascites.
•6. Cancer invasion of important surrounding organs or risk of esophageal tracheal fistula or esophageal pleural fistula.
•7. Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome.
•8. Known active hepatitis B or C infections (known positive HBsAg result or positive HCV antibody with detectable HCV ribonucleic acid \[RNA\] results).
•9. Active or prior documented autoimmune disease that may relapse.
+14 more criteria

Locations (1)

FuDan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 23, 2021

Primary Completion Date

January 25, 2022

Completion Date

May 12, 2023

Last Updated

March 3, 2025

Enrollment

ACTUAL participants

Conditions

Neoplasms Malignant

Interventions

AK117

DRUG

Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.

NCT06778382

Colorectal Neoplasms Malignant

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RECRUITINGPHASE3

Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

NCT05939687

Neoplasms MalignantRectal Cancer+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase 1 Dose Escalation and Expansion Study of AK117

Inclusion Criteria

Exclusion Criteria

Delayed Systemic Therapy Following Destructive Local Treatment of Pulmonary Oligometastases After No Evidence of Disease (NED) in Colorectal Cancer.

Prophylactic Mesh Placement During Stoma Closure After Low Anterior Resection

Local Cecal Cancer - Optimization of Surgical Treatment

Predicting Local and Distant Recurrence in T1 Colorectal Cancer

A Study of AK112, a PD-1/VEGF Bispecific Antibody, for Advanced Solid Tumors

A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104