A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASKG315 as a Single Agent and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Advanced Solid Tumors
- Sponsor
- AskGene Pharma, Inc.
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Safety[DLTs、AEs、ECG]
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The study is a Phase 1, open-label, multicenter, dose escalation study to evaluate the safety, tolerability, PK and PD of ASKG315 as a single agent (Part 1) and in combination with pembrolizumab (Part 2) in patients with advanced solid tumors.
Detailed Description
Each part of the study consists of 3 periods: screening (up to 28 days), treatment and follow-up. After an initial screening period, ASKG315 or ASKG315 combined with pembrolizumab will be administered once every 3 weeks by intravenous (IV) infusion. The Part 1 dose escalation consists of 6 planned escalation cohorts, with a starting dose of 3 mg. The Part 2 dose escalation consists of 4 planned escalation cohorts. Part 2 of the study will begin enrolling after Part 1 has successfully and safely dosed all patients in the first two cohorts and followed these patients through the entire DLT period. The starting dose of Part 2 will be determined according to the safety and PK of ASKG315 in Part 1 of the study, but in no case will it exceed the highest dose already safely administered in Part 1 and confirmed as tolerable by the Safety Review Committee in Part 1.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent form.
- •Male or female ≥ 18 years of age (at the time signed consent is obtained).
- •Histologically or cytologically confirmed advanced malignant solid tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available.
- •Measurable disease, per RECIST v1.
- •ECOG Performance Status of ≤
- •Life expectancy of ≥3 months, in the opinion of the Investigator.
- •Adequate organ function defined.
- •Fertile patients must be willing to use effective contraceptive measures (hormonal or barrier methods or abstinence, etc.) starting with the Screening visit through 90 days + 5 drug half-lives after the last dose of study treatment.
- •Negative serum pregnancy test for female patients within 7 days prior to the first dose of the study drug or documentation of lack of childbearing potential.
- •Willing and able to participate in the trial and comply with all trial requirements.
Exclusion Criteria
- •Patients who meet any of the following criteria are not allowed to be enrolled:
- •Received any other investigational drug for treatment that is not commercially available within 4 weeks prior to Cycle 1 Day
- •Received chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or any other anti-tumor treatments within 4 weeks prior to Cycle 1 Day
- •Had major organ surgery or significant trauma within 4 weeks prior to C1D1 or planning elective surgery during the study period.
- •Received systemic glucocorticoid or other immunosuppressant treatment within 14 days prior to C1D
- •Received immunomodulatory drugs, including but not limited to thymosin and interferon, within 14 days prior to C1D
- •Received a live attenuated vaccine within 4 weeks prior to C1D
- •Received IL-2 or IL-15 therapy within 12 weeks prior to C1D
- •History of hematologic stem cell transplant or solid organ transplant.
- •Adverse reactions to previous antitumor therapy have not recovered to CTCAE 5.0 grade ≤
Outcomes
Primary Outcomes
Safety[DLTs、AEs、ECG]
Time Frame: 21days
1. Incidence of dose limiting toxicities (DLTs) 2. Incidence of adverse events (AEs), laboratory abnormalities, and ECG abnormalities
Secondary Outcomes
- Immunocyte(21days)
- Maximum plasma concentration (Cmax)(21days)
- Area under the concentration time curve (AUC)(21days)
- Cytokine(21days)