Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors

PHASE1RecruitingINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

January 19, 2024

Primary Completion Date

April 30, 2027

Study Completion Date

June 30, 2027

Conditions
Advanced Solid TumorCutaneous TumorSubcutaneous TumorMalignant Solid TumorSolid TumorMetastatic Solid TumorMetastasis to Soft TissueNon Small Cell Lung CancerCutaneous Squamous Cell Carcinoma
Interventions
DRUG

tolododekin alfa

IT administration of ANK-101 once every 3 weeks for up to 12 weeks (4 doses); if there is no disease progression, decrease in clinical performance status or unacceptable toxicity, participants may receive 4 additional doses of ANK-101.

DRUG

Cemiplimab

Participants will receive four cycles of ANK-101 in combination with Cemiplimab. If there is no significant clinical deterioration as determined by the Investigator or unacceptable toxicity at Week 12, participants may receive an additional four cycles of the combination treatment. After stopping ANK-101 treatment, participants may stay on Cemiplimab monotherapy for an additional 24 weeks.

Trial Locations (5)

15232

RECRUITING

Hillman Cancer Center, Pittsburgh

20892

RECRUITING

National Cancer Institute, Bethesda

97213

RECRUITING

Providence Cancer Institute, Portland

02114

RECRUITING

Massachusetts General Hospital, Boston

M5G 2M9

RECRUITING

Princess Margaret Cancer Centre, Toronto

Sponsors
All Listed Sponsors
lead

Ankyra Therapeutics, Inc

INDUSTRY

NCT06171750 - Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors | Biotech Hunter | Biotech Hunter