HCC, Lung Cancer, Solid Tumor
Conditions
Keywords
Anti-PD-1, immunotherapy
Brief summary
This is a multi-center, multi-cohort, open-label, phase Ib/II study to evaluate the efficacy, safety, PK characteristics, immunogenicity and potential biomarkers of AK105 monotherapy in the patients with selected advanced solid tumors.
Interventions
DRUGAK105
Anti-PD-1 antibody
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
No
Inclusion criteria
1. Written and signed informed consent. 2. Aged over 18 and less than 75 years at the time of signing the informed consent form, both female and male. 3. ECOG PS is 0-1. 4. The expected survival time is ≥ 3months 5. Histologically or cytologically confirmed selected advanced solid tumor. 6. Subject must have at least one measurable lesion according to RECIST Version1.1. 7. Available archived tumor tissue sample to allow for correlative biomarker studies. In the setting where archival material is unavailable or unsuitable for use, the subject must consent and undergo fresh tumor biopsy. 8. Adequate organ function. 9. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product. 10. Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days after the last dose of investigational product. 11. Be willing and able to comply with scheduled visits, treatment regimens, laboratory tests and other requirements for the study.
Exclusion criteria
1. Had received experimental drug or used experimental device in the past within 4 weeks prior to the first dose of study drug. 2. Receipt of last radiotherapy or any anti-tumor treatment \[chemotherapy, targeted therapy, immunotherapy, Chinese patent drugs with antitumor indications, or immunomodulators or tumor embolization\] within 4 weeks prior to the first dose of study drug. 3. Had received any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, etc.), or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways (such as ICOS, CD40, CD137, GITR, OX40 antibody or drug), immunocytotherapy, therapeutic antibody, etc.). 4. Toxicity from previous anti-cancer therapy has not been alleviated or resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | Up to 2 years | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) | Up to 2 years | The DCR is defined as the proportion of subjects with CR, PR, or SD (subjects achieving SD will be included in the DCR if they maintain SD for ≥8 weeks) based on RECIST Version 1.1. |
| Duration of response (DoR) | Up to 2 years | Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first. |
| Number of participants with adverse events (AEs) | the time of informed consent signed through 90 days after the last dose of AK105 | 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. |
| Minimum observed concentration (Cmin) of AK105 at steady state | From first dose of AK105 through to 90 days after last dose of AK105 | The endpoints for assessment of PK of AK104 include serum concentrations of AK105 at different timepoints after AK105 administration. |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | From first dose of AK105 through to 90 days after last dose of AK105 | The immunogenicity of AK105 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs). |
| Progression-free survival (PFS) | Up to 2 years | Progression-free survival is defined as the time from the start of treatment with AK104 until the first documentation of disease progression or death due to any cause, whichever occurs first. |
Countries
China
Outcome results
None listed