A Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Ankyra Therapeutics, Inc
Study ID
NCT07027514
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • tolododekin alfa — DRUG
    Participants will receive tolododekin alfa as an intratumoral injection every 3 weeks (Q3W).
  • Cetrelimab — DRUG
    Participants will receive cetrelimab Q3W.

Study Details

A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Cohort A will enroll participants who have progressed on prior standard of care treatment with an anti-PD-1/PD-L1 antibody and a platinum-based chemotherapy regimen. Cohort B will enroll participants who are treatment-naïve for locally advanced or metastatic NSCLC.

Key Dates

Start date
Oct 22, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Participants will receive up to 8 cycles of tolododekin alfa in combination with cetrelimab given for up to 1 year
  • Experimental: Cohort B
    Participants will receive up to 8 cycles of tolododekin alfa in combination with the Investigator's choice of a Food and Drug Administration (FDA)-approved anti-PD-1/PD-L1 antibody given according to the FDA-approved label

Primary Outcome Measure

Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 [ Time Frame: 6 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Community Health NetworkIndianapolisIndiana46256
Neil Shukla, M.D.
[email protected]
7817185121
[email protected]
Neil Shukla, M.D. (PRINCIPAL_INVESTIGATOR)
Barbara Ann Karmanos Cancer HospitalDetroitMichigan48201
Tarik Hadid, M.D.
[email protected]
7817185121
Tarik Hadid, M.D. (PRINCIPAL_INVESTIGATOR)
Roswell Park Comprehensive Cancer CenterBuffaloNew York14263
Prantesh Jain, M.D.
[email protected]
7817185121
Prantesh Jain, M.D. (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Thomas Marron, M.D.
[email protected]
7817185121
Thomas Marron, M.D. (PRINCIPAL_INVESTIGATOR)
FirstHealth of the CarolinasPinehurstNorth Carolina28374
Michael Pritchett, D.O.
[email protected]
7817185121
Michael Pritchett, D.O. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Indianapolis, IN

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Community Health Network· Indianapolis, INBarbara Ann Karmanos Cancer Hospital· Detroit, MIRoswell Park Comprehensive Cancer Center· Buffalo, NYIcahn School of Medicine at Mount Sinai· New York, NYFirstHealth of the Carolinas· Pinehurst, NC

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