A Phase 1 Dose Escalation and Expansion Study of AK117

NCT04728334 | Completed Phase 1

• 1 other identifier: AK117-102
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms Malignant

Keywords

Antineoplastic Agents; Immunological

Outcome Measures

Primary Outcomes (2)

• Number of participants with adverse events (AEs)

  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.

  From the time of informed consent signed through 30 days after the last dose of AK117

• Number of participants with a Dose Limiting Toxicity (DLT)

  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 .

  During the first 21 days

Secondary Outcomes (5)

• Objective response rate (ORR)

  Up to 2 years

• Disease control rate (DCR)

  Up to 2 years

• Maximum observed concentration (Cmax) of AK117

  From first dose of AK117 through to 30 days after last dose of AK117

• Minimum observed concentration (Cmin) of AK117 at steady state

  From first dose of AK117 through to 30 days after last dose of AK117

• Number of subjects who develop detectable anti-drug antibodies (ADAs)

  From first dose of AK117 through to 30 days after last dose of AK117

Study Arms (1)

AK117 monotherapy

EXPERIMENTAL

AK117 monotherapy intravenous (IV) infusion - Weekly doses

Drug: AK117

Interventions

AK117 DRUG

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 monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All Subjects
• 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.
• Men or women aged ≥18 years and ≤75 at the time of study entry.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.
• Life expectancy ≥12 weeks.
• Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures as specified in the protocol.
• Subjects must provide the tumor tissue samples after the diagnosis of solid tumor or lymphoma.
• Adequate organ function.
• 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.
• 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.

You may not qualify if:

• All Subjects
• Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow up period of an interventional study.
• 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.
• 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.
• Metastasis or infiltration of brainstem and meninges;Metastasis or compression of the spinal cord; Active brain/central nervous system (CNS) metastases.
• Subjects with clinical symptoms or repeated drainage of pleural effusion, pericardial effusion or ascites.
• Cancer invasion of important surrounding organs or risk of esophageal tracheal fistula or esophageal pleural fistula.
• Known history of testing positive for human immunodeficiency virus (HIV) or known active acquired immunodeficiency syndrome.
• Known active hepatitis B or C infections (known positive HBsAg result or positive HCV antibody with detectable HCV ribonucleic acid \[RNA\] results).
• Active or prior documented autoimmune disease that may relapse.
• History of interstitial lung disease or noninfectious pneumonitis, except for those induced by radiation therapies.
• History of hemolytic anemia of any cause within 3 months prior to the first dose of investigational product.
• History of defects in RBC production, or hemoglobin production or metabolism.History of hemophagocytic lymphohistiocytosis.
• Previous or current gastrointestinal perforation, surgical incision, wound healing complications and bleeding events.
• Patients with clinically significant cardio-cerebrovascular disease.

Sponsors & Collaborators

• Akeso: lead

Study Sites (1)

FuDan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jiong Wu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2021
• First Posted: January 28, 2021
• Study Start: March 23, 2021
• Primary Completion: January 25, 2022
• Study Completion: May 12, 2023
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)