A Clinical Trial to Evaluate Effect of IAE0972 Combined with Chemotherapy for R/M HNSCC or NPC(No… (NCT06719479) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
A Clinical Trial to Evaluate Effect of IAE0972 Combined with Chemotherapy for R/M HNSCC or NPC(Note: It is Currently Phase II.).
60 participantsStarted 2025-01-01
Plain-language summary
Phase II: To evaluate the safety and tolerability of IAE0972 combined with chemotherapy selected by doctors for R/M HNSCC/NPC after failure or progress of ≤2-line system therapy, and to determine the MTD of combined therapy.
Phase III: According to the RECIST 1.1, the effectiveness of IAE0972 combined with chemotherapy regimen chosen by doctors compared with placebo plus chemotherapy regimen chosen by doctors was evaluated through OS in patients with R/M NPC who failed or progressed after treatment with ≤2-line system.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The age is 18\~75 years old (including the critical value), regardless of gender.
✓. Phase II cohort 1, cohort 2: locally advanced squamous cell carcinoma of the head and neck which only occurred in the oral cavity, oropharynx, hypopharynx and larynx after histological diagnosis or had no indication of radical local treatment; In the past, I only received ≤2 line therapy for recurrent and metastatic head and neck squamous cell carcinoma.
✓. Phase II cohort 3, cohort 4, cohort 5: Histologically confirmed nasopharyngeal carcinoma, stage IVb or recurrent nasopharyngeal carcinoma that is not suitable for local treatment according to the TNM of AJCC nasopharyngeal carcinoma in the 8th edition of 2017; In the past, they only received ≤2 line therapy for recurrent and metastatic nasopharyngeal carcinoma.
✓. According to the researcher's judgment, the chemotherapy in this experiment is applicable.
✓. According to the RECIST 1.1 standard, there is at least one measurable lesion (tumor lesions located in previous radiotherapy areas or other local regional treatment sites are generally not regarded as measurable lesions, unless the lesions make clear progress or persist after radiotherapy for three months).
✓. The score of physical condition of the ECOG is 0\~1.
✓. The estimated survival time is ≥3 months.
✓. Have sufficient organ functions:
Exclusion criteria
✕. Having received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before the first use of the investigating drug, the following drugs should be excluded according to the following criteria:
What they're measuring
1
Number of participants with treatment-related adverse events assessed by CTCAE v5.0.
✕. Received other unlisted clinical research drugs or treatments within 4 weeks before using the research drugs.
✕. The adverse reactions of previous anti-tumor treatments have not recovered to NCI CTCAE 5.0 grade evaluation ≤1 grade or the relevant provisions of the selection criteria (except for the toxicity that the researchers judged to have no safety risk, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.).
✕. It is known that it has hypersensitivity to any antibody drugs (NCI CTCAE 5.0 rating is ≥3), or it has hypersensitivity to research drugs, active ingredients or inactive excipients of chemotherapy schemes.
✕. Have received major surgery (excluding puncture biopsy), major trauma or need to undergo elective surgery during the trial within 4 weeks before the first use of the study drug.
✕. Having received systemic corticosteroids (prednisone \> 10 mg/day or similar drugs with the same dose) within 14 days before the first use of the study drug, except for the following cases: using topical, ophthalmic, intra-articular and intranasal corticosteroids; Short-term use of glucocorticoids for preventive treatment (for example, prevention of contrast agent allergy).
✕. Treatment with other immunosuppressants within 28 days or 5 half-lives (whichever is longer) before the first use of the study drug.
✕. Have used immunomodulatory drugs within 14 days before the first use of the study drug (Appendix 5).