Advanced Solid Tumors, Melanoma
Conditions
Keywords
Bispecific, PD1/CTLA4, PD-1/PD-L1 relapsed/refractory tumors
Brief summary
A multicenter, open-label, phase 1b/2 study to evaluate the safety and efficacy of AK104, a PD-1 and CTLA-4 bispecific antibody, in selected advanced solid tumors.
Interventions
BIOLOGICALAK104
AK104, 6mg/kg, Q2W
Sponsors
Akeso Pharmaceuticals, Inc.
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. Male or female, age ≥ 18 years and ≤75, at the time of study entry. 3. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 4. Estimated life expectancy of ≥3 months. 5. Histologically or cytologically documented advanced or metastatic melanoma and other selected advanced solid tumors. 6. Subjects must have at least one measurable lesion per RECIST v1.1. 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 (biopsy at acceptable risk as judged by the investigator). 8. Adequate organ functions. 9. Female subjects of childbearing potential who are sexually active with a nonsterilized male partner must use an acceptable method of contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of investigational product. 10. Subjects who agree to take effective contraception methods from screening to 120 days after the last dose of investigational product. 11. Willing to follow all the experimental requirements designated by the protocol.
Exclusion criteria
1. Prior use of investigational products or devices within 4 weeks prior to the first administration of the study treatment. 2. Concurrent enrollment into another clinical study, except the study belongs to investigational, non-interventional studies or the follow-up period of interventional studies. 3. Prior exposure to anti-tumor therapies, including systematic chemotherapy, radiotherapy, immunotherapy, hormone therapy, targeted therapy (within 2 weeks before the first administration of the study treatment), and systematic immune-modulators (including but not limited to interferon, interleukin-2 and tumor necrosis factor) within 4 weeks prior to the first administration of the study treatment. Prior exposure to Chinese herbal medicine or proprietary Chinese medicine with anti-tumor functions within 2 weeks prior to the first administration of the study treatment. 4. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 Grade 0 or 1, or to levels dictated in the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-tumor activity of AK104 using objective response rate (ORR) based on RECIST v1.1 as assessed by the investigator | 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. |
| 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. |
| Overall survival (OS) | Up to 2 years | Overall survival is defined as the time from the start of treatment with AK104 until death due to any cause. |
| Number of subjects experiencing adverse events (AEs) | From the time of informed consent through 90 days after last dose of AK104 | 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 AK104 at steady state | From first dose of AK104 through to 90 days after last dose of AK104 | The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration. |
| Number of subjects who develop detectable anti-drug antibodies (ADAs) | From first dose of AK104 through to 90 days after last dose of AK104 | The immunogenicity of AK104 will be assessed by summarizing the number of subjects who develop detectable anti-drug antibodies (ADAs). |
| 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. |
Countries
China
Outcome results
None listed