Clincosm LogoSign in Get a demo

A Study of AK130 in Patients With Advanced Malignant Tumors

Sponsor
Akeso (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05653284
Collaborator
(none)
72
Enrollment
1
Arm
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

A Phase I open label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of AK130 (TIGIT/TGF-β bifunctional fusion protein) in patients with advanced malignant tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
72 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AK130 (TIGIT/TGF-β Bifunctional Fusion Protein) in Patients With Advanced Malignant Tumors
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: AK130

Each subject will receive a single dose of AK130 every 3-week cycle (Q3W) or every 2-week cycle (Q2W). Participants may continue on study drug until unacceptable toxicity, or other withdrawal criteria is met.

Drug: AK130
IV infusion, specified dose on specified days.

Outcome Measures

Primary Outcome Measures

  1. Incidence and severity of participants with adverse events (AEs) [From time ICF is signed until 90 days after last dose of AK130]

  2. Number of participants with DLTs [During the first four weeks of treatment with AK130]

Secondary Outcome Measures

  1. Objective response rate (ORR) [Up to approximately 2 years]

  2. Disease control rate (DCR) [Up to approximately 2 years]

  3. Progression-free survival (PFS) [Up to approximately 2 years]

  4. Overall survival (OS) [Up to approximately 2 years]

  5. Duration of Response (DOR) [Up to approximately 2 years]

  6. Time to response (TTR) [Up to approximately 2 years]

  7. Maximum observed concentration (Cmax) of AK130 [From first dose of study drug through end of treatment (up to approximately 2 years)]

    The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration.

  8. Minimum observed concentration(Cmin) of AK130 [From first dose of study drug through end of treatment (up to approximately 2 years)]

    The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration.

  9. Area under the curve (AUC) of AK130 for assessment of pharmacokinetics [From first dose of study drug through end of treatment (up to approximately 2 years)]

    The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration.

  10. Number of subjects who develop detectable anti-drug antibodies (ADAs) [From first dose of study drug through 30 days after last dose of study drug]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Written and signed informed consent and any locally required authorization obtained from the subject/legal representative.

  2. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.

  3. Life expectancy ≥3 months.

  4. Histologically or cytologically documented unresectable advanced or metastatic malignant tumor that has failed or intolerant of standard therapy, or for which no effective standard therapy is available.

  5. Subject must have at least one measurable lesion according to RECIST Version1.1.

  6. Adequate organ function.

Exclusion Criteria:

  1. Any malignancy other than the disease under study within the past 3 years except for radically cured local cancers, such as basal cell skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of breast.

  2. Receipt of any anti-TIGIT, anti-TGF-β treatment.

  3. Experienced a toxicity that led to permanent discontinuation of prior immunotherapy. All AEs while receiving prior immunotherapy have not completely resolved or resolved to Grade 1 prior to screening, required the use of additional immunosuppression other than corticosteroids.

  4. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1，or to levels dictated in the inclusion/exclusion criteria, except toxicities not considered a safety risk (e.g., alopecia, neuropathy, or asymptomatic laboratory abnormalities).

  5. Major surgical procedure within 4 weeks prior to the first dose of AK130 or still recovering from prior surgery.

  6. History of organ transplant.

  7. Known allergy or reaction to any component of the AK130 formulation. History of severe hypersensitivity reactions to other mAbs.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Akeso

Investigators

  • Principal Investigator: Jinming Yu, The Cancer Hospital Affiliated to Shandong First Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Akeso
ClinicalTrials.gov Identifier:
NCT05653284
Other Study ID Numbers:
  • AK130-101
First Posted:
Dec 16, 2022
Last Update Posted:
Dec 16, 2022
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Dec 16, 2022