A Study of AK130 in Patients With Advanced Malignant Tumors

Advanced Malignant Tumors Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05653284
• Other study ID #: AK130-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 2023
• Est. completion date: January 2025

Study information

• Verified date: December 2022
• Source: Akeso
• Contact: Weifeng Song
• Phone: +86(0760)89873999
• Email: clinicaltrials[@]akesobio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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-ß 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.

Related Conditions & MeSH terms

• Advanced Malignant Tumors
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Akeso

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of participants with adverse events (AEs)		From time ICF is signed until 90 days after last dose of AK130
Primary	Number of participants with DLTs		During the first four weeks of treatment with AK130
Secondary	Objective response rate (ORR)		Up to approximately 2 years
Secondary	Disease control rate (DCR)		Up to approximately 2 years
Secondary	Progression-free survival (PFS)		Up to approximately 2 years
Secondary	Overall survival (OS)		Up to approximately 2 years
Secondary	Duration of Response (DOR)		Up to approximately 2 years
Secondary	Time to response (TTR)		Up to approximately 2 years
Secondary	Maximum observed concentration (Cmax) of AK130	The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration.	From first dose of study drug through end of treatment (up to approximately 2 years)
Secondary	Minimum observed concentration(Cmin) of AK130	The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration.	From first dose of study drug through end of treatment (up to approximately 2 years)
Secondary	Area under the curve (AUC) of AK130 for assessment of pharmacokinetics	The endpoints for assessment of PK include serum concentrations of AK130 at different timepoints after AK130 administration.	From first dose of study drug through end of treatment (up to approximately 2 years)
Secondary	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