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

Conditions

• Non Small Cell Lung Cancer

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

First listed

Jun 18, 2025

Start date

Oct 22, 2025

Status verified

Sep 2026

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

• Ankyra Therapeutics
  7817185121
  [email protected]

Locations (11)

Find similar trials in Coral Gables, FL

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