Evaluating ASKG915 for advanced solid tumors
A Phase 1 Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASKG915 in Patients With Selected Advanced Solid Tumors
PHASE1; PHASE2 · AskGene Pharma, Inc. · NCT05867420
This study is testing a new drug called ASKG915 to see if it is safe and how well it works for people with advanced solid tumors that haven’t responded to other treatments.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 594 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AskGene Pharma, Inc. (industry) |
| Locations | 4 sites (New York, New York and 3 other locations) |
| Trial ID | NCT05867420 on ClinicalTrials.gov |
What this trial studies
This Phase 1 study investigates the safety, tolerability, and pharmacokinetics of ASKG915 in patients with selected advanced solid tumors. It consists of a two-part design, including dose escalation and expansion phases, to assess how well the drug is tolerated and its effects on the body. The study aims to enroll patients whose tumors are refractory to standard therapies or for whom no standard treatment options are available.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced malignant tumors that are refractory to or intolerant of all standard therapies.
Not a fit: Patients with known cerebral or meningeal metastasis or those with serious cardiovascular or autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that currently have limited treatment alternatives.
How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise in evaluating new therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced malignant tumor that is refractory to or intolerant of all standard therapy or for which no standard therapy is available. 2. ECOG performance status of ≤ 2. 3. Life expectancy of ≥ 3 months. 4. The results of the laboratory tests must meet all criteria. Exclusion Criteria: 1. Patients have received antitumor therapy during the first 4 weeks before study drug use. 2. Received a live attenuated vaccine within 4 weeks prior to C1D1. 3. Known cerebral parenchymal metastasis or meningeal metastasis. 4. History of serious cardiovascular or cerebrovascular diseases. 5. Active or recurrent autoimmune diseases. 6. History of ascites or pleural effusion requiring drainage. 7. Pregnant or lactating or planning to become pregnant at any time during the study, including the Follow-up Period.
Where this trial is running
New York, New York and 3 other locations
- Columbia University Irving Medical Center — New York, New York, United States (RECRUITING)
- UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Peking University Cancer Hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Medical Director
- Email: chenjing@ask-pharm.com
- Phone: 805-389-2956
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Advanced Solid Tumors, PD-1/IL-15