Trials Sponsors Conditions Drugs Pricing

Conditions

Advanced or Metastatic Solid Tumors Malignancy Metastasis

Outcome Measures

Primary Outcomes (2)

Incidence of 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 drug, whether or not considered related to the study drug.
From the time of informed consent signed through to 90 days after last dose of study drug
Number of participants with a Dose Limiting Toxicity (DLTs)
DLTs will be assessed as having a suspected relationship to study drug according to pre-specific criteria in the protocol.
Within the first 28 days after receiving the first dose of study drug

Secondary Outcomes (4)

Serum pharmacokinetics (PK)
From first dose of treatment through to 90 days after end of treatment
Number of subjects who develop detectable anti-drug antibodies (ADAs)
From first dose of study drgu through to 90 days after end of treatment
Objective response rate (ORR)
Up to 2 years
Disease control rate (DCR)
Up to 2 years

Study Arms (1)

Intervention/treatment

EXPERIMENTAL

Experimental

Drug: AK114

Interventions

AK114Drug

AK114 administered by subcutaneous injection

Intervention/treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Written and signed informed consent
Age ≥ 18

Sponsors & Collaborators

Akeso
Industrylead

Study Sites (1)

Ashford Cancer Centre

Kurralta Park, South Australia, Australia

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

Alex HL Wong, MMedSc
Akeso
STUDY DIRECTOR

Central Study Contacts

Alex HL Wong, MMedSc

CONTACT

+86(0760)89873999 global.trials@akesobio.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Masking Details: None (open Label)
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 20, 2022

Study Start

March 15, 2022

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

Intervention/treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Study Arms (1)

Intervention/treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations