A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 as Monotherapy or in Combination With AK104
- Conditions
- Neoplasms Malignant
- Registration Number
- NCT04349969
- Lead Sponsor
- Akesobio Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Able to provide written and signed informed consent<br><br> 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1.<br><br> 3. Life expectancy =12 weeks<br><br> 4. Females of childbearing potential and non-sterilized males who are sexually active<br> must use an effective method of contraception from screening until 120 days after<br> final dose of investigational product or women of non-childbearing potential.<br><br> 5. Willing to receive blood transfusion(s) when so advised by the investigator.<br><br> 6. Adequate organ function.<br><br> 7. Subjects must have a histologically or cytologically confirmed advanced solid tumor<br> that is refractory or relapsed to the current standard therapies or which no<br> effective standard therapy is available.<br><br> 8. At least 1 measurable lesion according to RECIST v1.1<br><br>Exclusion Criteria:<br><br> 1. Concurrent enrollment in another clinical study excluding observational trials<br><br> 2. Prior malignancy active within the previous 3 years except for the tumor for which a<br> subject is enrolled in the study<br><br> 3. Active brain/central nervous system (CNS) metastases<br><br> 4. Active infections requiring systemic therapy within 2 weeks prior to the first dose<br> of investigational product.<br><br> 5. Known history of HIV.<br><br> 6. Known active hepatitis B or C infections<br><br> 7. Active or prior documented autoimmune disease that may relapse.<br><br> 8. History of interstitial lung disease or non-infectious pneumonitis, except those<br> induced by radiation therapies.<br><br> 9. History of defects in RBC production, or hemoglobin production or metabolism<br><br> 10. Patients with clinically significant cardio-cerebrovascular disease.<br><br> 11. History of severe hypersensitivity reactions to other mAbs.<br><br> 12. History of organ transplantation.<br><br> 13. Receiving any anticancer therapy targeting the CD47/SIRPa ; Anticancer small<br> molecule targeted agent within 2 weeks prior to the first dose of the<br> investigational product; Anticancer mAbs within 6 weeks prior to the first dose of<br> investigational product or 5 half-lives (whichever is lesser); Other anticancer<br> therapy within 4 weeks prior to the first dose of the investigational product;<br><br> 14. Subjects with a condition requiring systemic treatment with either corticosteroid<br> (>10 mg daily doses)) or other immunosuppressive medications within 2 weeks prior to<br> the first dose of investigational product.<br><br> 15. Received a live attenuated vaccine within 4 weeks prior to the first dose of<br> investigational product.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and nature of adverse events (AEs);Number of participants with a Dose Limiting Toxicity (DLT)
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR);Disease control rate (DCR);Maximum observed concentration (Cmax) of AK117 as monotherapy or in combination with AK104 and Minimum observed concentration (Cmin) of AK117 at steady stateconcentration (Cmin) of AK117 at steady state;Number of subjects who develop detectable anti-drug antibodies (ADAs) of AK117 as monotherapy or in combination with AK104;Area under the curve (AUC) of AK117 as monotherapy or in combination with AK104 for assessment of pharmacokinetics;Receptor occupancy (RO) of AK117 as monotherapy or in combination with AK104 to evaluate target engagement