Tolododekin Alfa + Cetrelimab for Non-Small Cell Lung Cancer

Recruiting at 4 trial locations

Overseen By Ankyra Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Ankyra Therapeutics, Inc

Must not be taking: Immunosuppressants, Steroids, Warfarin, others

Disqualifiers: EGFR/ALK mutations, Autoimmune disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of treatments for people with advanced non-small cell lung cancer (NSCLC). Researchers aim to determine if tolododekin alfa (an experimental treatment), combined with cetrelimab (an immunotherapy drug) or another approved treatment, can effectively combat the cancer. The trial includes two groups: one for individuals who have already tried standard treatments, such as certain chemotherapy and immunotherapy, and another for those who have not yet received treatment for advanced NSCLC. Suitable candidates for this trial are those with advanced NSCLC who exhibit noticeable symptoms and are willing to undergo a fresh tumor biopsy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressive therapy or certain other treatments, you may need to stop them before starting the trial. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tolododekin alfa, when combined with an anti-PD-1/PD-L1 antibody like cetrelimab, is being tested for safety in patients with advanced non-small cell lung cancer. Early studies focus on determining the safety of this combination and identifying potential side effects.

Detailed reports on side effects for this combination remain limited. However, since cetrelimab affects the immune system, some patients may experience fatigue or skin reactions. As tolododekin alfa is a newer treatment, researchers are closely monitoring for any unique effects it might cause.

The trial aims to monitor participants carefully to ensure their safety while exploring the potential benefits of this treatment combination. Prospective participants should discuss any concerns with the trial team, who can provide more detailed information tailored to individual health needs. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Tolododekin Alfa and Cetrelimab for treating non-small cell lung cancer because it brings a fresh approach to battling the disease. Unlike standard treatments that often focus solely on blocking PD-1/PD-L1 pathways, this combination introduces Tolododekin Alfa, which has the potential to enhance immune response by modulating cytokine activity. This dual-action strategy not only targets cancer cells more effectively but also aims to boost the body's natural immune defenses to sustain longer-lasting effects. By combining these mechanisms, there’s hope for improved outcomes and possibly faster responses compared to existing therapies.

What evidence suggests that tolododekin alfa + cetrelimab could be an effective treatment for non-small cell lung cancer?

Research has shown that tolododekin alfa, when combined with an anti-PD-1/PD-L1 antibody, may help treat advanced non-small cell lung cancer (NSCLC). In this trial, participants in Cohort A will receive tolododekin alfa with cetrelimab, while those in Cohort B will receive tolododekin alfa with the Investigator's choice of an FDA-approved anti-PD-1/PD-L1 antibody. Early studies have found that tolododekin alfa is generally safe and has shown positive effects in treating various cancers, including NSCLC. This combination boosts the immune system's ability to fight cancer by blocking proteins that allow tumors to evade detection. Initial results suggest this method might benefit patients who haven't responded well to other treatments. Cetrelimab, used in Cohort A, targets the PD-1/PD-L1 pathway, a well-established approach in lung cancer treatment. ^{1 2 3 5 6}

Who Is on the Research Team?

Thomas Marron, MD

Principal Investigator

The Tisch Cancer Center, Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults with advanced non-small cell lung cancer (NSCLC). Participants must have either progressed after standard treatments or be treatment-naïve. They should have normal thyroid function, measurable disease, good performance status, and a stable heart rhythm. Women of childbearing potential and men must use effective contraception.

Inclusion Criteria

My doctor expects me to live more than 12 weeks.

My recent heart test shows no signs of a heart attack or abnormal heart rhythm.

My lung cancer is advanced or has spread to other areas.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 8 cycles of tolododekin alfa in combination with an anti-PD-1/PD-L1 antibody

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cetrelimab
• Tolododekin Alfa

Trial Overview The study tests Tolododekin Alfa (ANK-101) combined with an anti-PD-1/PD-L1 antibody called Cetrelimab in NSCLC patients. Cohort A includes those previously treated with similar drugs and chemo; Cohort B includes those who haven't received such treatments.

How Is the Trial Designed?

Group I: Cohort B Experimental Treatment 1 Intervention

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

Group II: Cohort A Experimental Treatment 2 Interventions

Participants will receive up to 8 cycles of tolododekin alfa in combination with cetrelimab given for up to 1 year

Who Is Running the Clinical Trial?

Ankyra Therapeutics, Inc

Lead Sponsor

Trials

1

Recruited

110+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07027514

NCT07027514 | A Study of Tolododekin Alfa (ANK-101) in ... 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 · Study Overview.

2. patlynk.com patlynk.com/trial/NCT07027514

Tolododekin Alfa (ANK-101) and Anti-PD-1/PD-L1 ... This study focuses on testing a new combination of treatments for people with advanced non-small cell lung cancer (NSCLC). It looks at the effects of a drug ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-07002

A Study of Tolododekin Alfa (ANK-101) in Combination ... 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.

4. synapse.patsnap.com synapse.patsnap.com/drug/a9f29939c2bc4041a4c0bbd4a615e8aa

Tolododekin Alfa - Drug Targets, Indications, Patents A Phase 1b, Two-Part Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung ...

5. businesswire.com businesswire.com/news/home/20251104335799/en/Ankyra-Announces-Publication-of-Phase-1-Clinical-Data-and-Will-Present-at-the-Society-for-Immunotherapy-of-Cancer-SITC-Annual-Meeting

Ankyra Announces Publication of Phase 1 Clinical Data ... “Tolododekin alfa demonstrated a tolerable safety profile and treatment was associated with monotherapy clinical activity in several types of ...

6. ankyratx.com ankyratx.com/press-releases/ankyra-therapeutics-announces-phase-1-clinical-data-at-the-2025-aacr-annual-meeting-and-the-first-patient-has-been-dosed-with-tolododekin-alfa-and-cemiplimab/

Ankyra Therapeutics Announces Phase 1 Clinical Data at ... Ankyra Therapeutics Announces Phase 1 Clinical Data at the 2025 AACR Annual Meeting and the first patient has been dosed with tolododekin alfa ...