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:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-24 @ 9:43 PM
NCT ID:
NCT05060432
Eligibility Criteria:
Inclusion Criteria:
* Provide a signed written informed consent for the trial
* Have measurable disease, per RECIST v1.1
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 or 1.
* Have adequate organ functions
* Part 1A/1B/1C/1D/1E/1F: Have histologically or cytologically confirmed advanced or metastatic solid tumor for whom no standard treatment with survival benefit is available
Part 1G (NSCLC):
* Have a histologically confirmed or cytologically confirmed previously untreated stage IV OR stage III not amenable to curative chemoradiotherapy or surgery (AJCC 8th edition) nonsquamous NSCLC OR squamous NSCLC.
* Are eligible to receive anti-PD(L)1 therapy combined with chemotherapy in first line metastatic setting
Part 2 (H\&N cancer)
* Have histologically or cytologically confirmed recurrent advanced or metastatic head and neck squamous cell carcinoma considered incurable by local therapies
* PD-L1 status positive
Exclusion Criteria:
* Have received any anti-cancer therapy within 4 weeks prior to the first dose
* Have received a live vaccine within 30 days prior to the first dose
* Have known primary CNS cancer.
* Have known CNS metastases unless previously treated and well controlled for at least 1 month
* Have concomitant second malignancies unless a complete remission was achieved at least 2 years before study entry
* Have a history of Grade ≥ 2 pneumonitis, active autoimmune disease, or persistent immune-mediated toxicity caused by immune checkpoint inhibitor therapy of Grade ≥ 2
* Have toxicity (except for alopecia) related to prior anti-cancer therapy and/or surgery unless the toxicity is either resolved, returned to baseline or Grade 1, or deemed irreversible.
* Have uncontrolled or significant cardiovascular disease
* Part 1: major surgery within 3 weeks before initiating treatment
* Part 1: Have received prior radiotherapy within 2 weeks of start of study treatment
* Part 2 (H\&N cancer):
* Have received prior immunotherapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
* Have received prior chemotherapy administered in the recurrent advanced or metastatic setting (except for systemic therapy completed \> 6 months prior to screening if given as part of multimodal treatment for locally advanced disease)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05060432
Study Brief:
Protocol Section:
NCT05060432