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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

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from date of treatment start until data cut-off for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events(AEs)

Dose limiting toxicities (DLTs)

Secondary outcome measures

Area under the concentration time curve (AUC)

Evaluation of immunogenicity

Maximum plasma concentration (Cmax)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ASKG915Experimental Treatment1 Intervention

Single or multiple ascending dose of ASKG915.

Do I qualify?Apply below to find out

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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

13 Previous Clinical Trials

2,494 Total Patients Enrolled

Barbara Hickingbottom, MDStudy DirectorAsk-Gene Pharma, Inc.

6 Previous Clinical Trials

514 Total Patients Enrolled

Media Library

ASKG915 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05867420 — Phase 1

Solid Tumors Research Study Groups: ASKG915

Solid Tumors Clinical Trial 2023: ASKG915 Highlights & Side Effects. Trial Name: NCT05867420 — Phase 1

ASKG915 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05867420 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you explain the potential risks associated with ASKG915?

"The safety of ASKG915 has been rated as a 1 due to the limited information that is currently available on its efficacy and risk profile. This drug is in phase 1 clinical trials, thus further data collection needs to be done before it can receive a higher score."

Answered by AI

Is the current recruitment phase of this clinical trial still open?

"Affirmative. The information hosted on clinicaltrials.gov demonstrates that this medical trial, initially posted on August 3rd 2023, is actively recruiting participants. 104 patients must be sourced from 1 location for the completion of this experiment."

Answered by AI

What ultimate outcomes is this investigation aiming to achieve?

"As reported by AskGene Pharma, Inc., the primary metric for this trial will be Adverse Events (AEs) monitored over a 21-day window. Secondary outcomes include Area Under Concentration Curve (AUC), Plasma Clearance Rate (CL), and Immunogenicity expressed as Anti-Drug Antibodies (ADA)."

Answered by AI

What is the current enrollment size of this research project?

"Indeed, clinicaltrials.gov states that this research is actively seeking volunteers. It was first posted on August 3rd 2023 and the most recent update dates to August 7th 2023. The target recruitment figure of 104 patients will be sourced from 1 medical location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.

2023. "A Study of ASKG915 in Patients With Selected Advanced Solid Tumors.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05867420.