Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:09 AM
Ignite Modification Date:
2025-12-25 @ 4:09 AM
NCT ID:
NCT05061420
Eligibility Criteria:
Inclusion Criteria:
-Participants were ≥ 18 years of age inclusive, at the time of signing the informed consent
* Histologically or cytologically confirmed diagnosis of R/M HNSCC that was considered not amenable to further therapy with curative intent. The eligible primary tumor locations were oropharynx, oral cavity, hypopharynx, and larynx (nasopharynx is excluded).
* Measurable disease.
* Baseline biopsy was submitted for all cohort A1 Core Phase participants.
* Baseline biopsy was submitted for all cohort B1, B2 Expansion Phase participants.
* Known HPV p16 status for oropharyngeal cancer.
* Participant agreed to follow protocol-specified contraception guidelines.
Exclusion Criteria:
-Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
* Had received prior IL2-based anticancer treatment. -For participants in Cohort A1: Prior treatment with an agent (approved or investigational) that blocks the PD-1/PD-L1 pathway (participants who joined a study with an anti-PD-1/PD-L1 in the experimental arm but have written confirmation they have not received anti-PD-1/PD-L1 are allowed).
* For participants in Cohort B2: Prior treatment with cetuximab (prior cetuximab allowed if used for the treatment of locally advanced disease, with no progressive disease for at least 4 months from completion of prior cetuximab therapy).
* For participants in Cohort B2: Electrolytes (magnesium, calcium, potassium) outside the normal ranges.
* Participants under anti-hypertensive treatment who cannot temporarily (for at least 36 hours) withhold antihypertensive medications prior to each IMP dosing.
* Participants with baseline SpO2 ≤92% (without oxygen therapy).
* Comorbidity requiring corticosteroid therapy (\>10 mg prednisone/day or equivalent) within 2 weeks of IMP initiation. Inhaled or topical steroids are permitted, provided that they were not for treatment of an autoimmune disorder. Participants who require a brief course of steroids (eg, as prophylaxis for imaging studies due to hypersensitivity to contrast agents) were not excluded.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05061420
Study Brief:
Protocol Section:
NCT05061420