Advanced Malignant Solid Tumors
Conditions
Brief 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.
Interventions
DRUGAK150
IV infusion, administered on Day 1 of each cycle, Q2W,continuous treatment
Sponsors
Akeso
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with a Dose Limiting Toxicity (DLT) | During the first 4 weeks | 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 |
| Number of participants with adverse events (AEs) | 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. | An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum PK concentration of AK150 | From pre-dose to the end of the last dose, an average of 6 months. | Serum PK of AK150 at different timepoints after AK150 administration |
| The immunogenicity of AK150 | From pre-dose to 30 days post end of treatment | The immunogenicity of AK150 will be assessed by summarizing the number of participants who develop detectable anti-drug antibodies (ADAs) |
| Overall response rate (ORR) | Up to 12 year. | Efficacy measures such as ORR, which is the proportion of participants with CR or PR by investigator based on RECIST v1.1 |
| Progression-Free Survival(PFS) | Up to 1 year | PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1. |
| Disease control rate(DCR) | Up to 1 year. | DCR, which is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1. |
Countries
China
Contacts
CONTACTZhifang Yao, PHD
Outcome results
None listed