Clinical trial · Interventional
A Phase I Clinical Study of AK150 in Advanced Malignant Solid Tumor
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK150 in Advanced Malignant Solid Tumor
NCT07566247CI-TRIAL-00110501not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Solid Tumors | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK150 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AK150
- description
- Each subject will receive a single dose of AK150 every 2-week cycle (Q2W).
- interventionNames
- Drug: AK150
Primary outcomes (2)
- measure
- Number of participants with a Dose Limiting Toxicity (DLT)
- timeFrame
- During the first 4 weeks
- description
- DLTs will be assessed during the first 4 weeks of treatment for dose-escalation I phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 2 cycles (4 weeks) of treatment
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be able to understand and voluntarily sign the written informed consent form. 2. Aged of ≥ 18 years and ≤75 years. 3. ECOG PS 0 or 1. 4. The expected lifespan is ≥3 months. 5. 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. 6. At least one measurable lesion according to RECIST v1.1. 7. Adequate organ function. 8. 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: 1. Having other active malignancies within 3 years. 2. Currently participating in another interventional clinical study. 3. Presence of active metastases to the central nervous system. For participants with asymptomatic brain metastasis or stable symptoms after treatment can be included. 4. Having received any treatment targeting CSF-1R, ILT2 and ILT4.. 5. Having received systemic anti-tumor treatment within 28 days or major surgical operations are expected to be required during the study period. 6. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower. 7. Participants with clinically significant cardiovascular or cerebrovascular diseases or risks. 8. Participants with active autoimmune diseases requiring systemic treatment within 2 years. 9. Active infections, including those requiring intravenous antibiotics and antifungal treatment 2 weeks before the administration of the study, and unexplained fever during the screening period. 10. Known to be positive for HIV and other infections. 11. Live attenuated vaccines were received within 28 days. 13\. Participants with a history of mental illness and incapacitated or limited capacity. 14\. Women who are pregnant or lactating. 15.Known history of active tuberculosis. 16.Currently enrolled in any other clinical study. 17.Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.
References
Publications (0)
Data not yet available
No reference posted for this study.