A Phase I Clinical Study of AK150 in Advanced Malignant Solid Tumor (NCT07566247) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Clinical Study of AK150 in Advanced Malignant Solid Tumor
China96 participantsStarted 2026-04-30
Plain-language summary
This study is an open-label, multicenter, dose-escalation and dose-expansion Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of AK150 in patients with advanced malignant solid tumors.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Be able to understand and voluntarily sign the written informed consent form.
✓. Aged of ≥ 18 years and ≤75 years.
✓. ECOG PS 0 or 1.
✓. The expected lifespan is ≥3 months.
✓. Histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject is not suitable for standard therapy.
✓. At least one measurable lesion according to RECIST v1.1.
✓. Adequate organ function.
✓. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception
Exclusion criteria
✕. Having other active malignancies within 3 years.
✕. Currently participating in another interventional clinical study.
✕. Presence of active metastases to the central nervous system. For participants with asymptomatic brain metastasis or stable symptoms after treatment can be included.
✕. Having received any treatment targeting CSF-1R, ILT2 and ILT4..
✕
What they're measuring
1
Number of participants with a Dose Limiting Toxicity (DLT)
Timeframe: During the first 4 weeks
2
Number of participants with adverse events (AEs)
Timeframe: From the participant signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first.