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Cancer Vaccine
ASKG915 for Solid Tumors
Phase 1
Recruiting
Research Sponsored by AskGene Pharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years from date of treatment start until data cut-off
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug to see if it's safe & effective against cancer in people with advanced tumors.
Who is the study for?
This trial is for adults with advanced solid tumors that haven't responded to standard treatments or have no standard options left. They should be relatively stable (ECOG ≤ 2), expected to live at least 3 more months, and meet specific lab test criteria. People can't join if they've had recent antitumor therapy, live vaccines, autoimmune diseases, problematic fluid buildup needing drainage, are pregnant/breastfeeding/planning pregnancy during the study period, have brain metastases or serious heart/stroke issues.
What is being tested?
The trial is testing ASKG915's safety and how it affects the body in patients with certain advanced solid tumors. It's an early-phase study where researchers gradually increase doses to find a safe amount while monitoring how participants' bodies process the drug.
What are the potential side effects?
Since this is a Phase 1 dose escalation study of ASKG915 focusing on safety and tolerability, specific side effects aren't listed yet but may include typical reactions like nausea, fatigue, allergic responses or other symptoms depending on how the drug interacts with different tumor types.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years from date of treatment start until data cut-off
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years from date of treatment start until data cut-off
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adverse events(AEs)
Dose limiting toxicities (DLTs)
Secondary study objectives
Area under the concentration time curve (AUC)
Evaluation of immunogenicity
Maximum plasma concentration (Cmax)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ASKG915Experimental Treatment1 Intervention
Single or multiple ascending dose of ASKG915.
Find a Location
Who is running the clinical trial?
AskGene Pharma, Inc.Lead Sponsor
6 Previous Clinical Trials
1,055 Total Patients Enrolled
Jiangsu Aosaikang Pharmaceutical Co., Ltd.Industry Sponsor
14 Previous Clinical Trials
2,521 Total Patients Enrolled
Barbara Hickingbottom, MDStudy DirectorAsk-Gene Pharma, Inc.
6 Previous Clinical Trials
534 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had fluid drained from my abdomen or chest.My cancer has spread to my brain or its coverings.I have had serious heart or stroke-related diseases.I have received cancer treatment within the last 4 weeks.I have not received a live vaccine in the last 4 weeks.My cancer does not respond to standard treatments or I cannot tolerate them.I can take care of myself and perform daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: ASKG915
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.