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Cancer Vaccine
ALG.APV-527 for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by Aptevo Therapeutics
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 through completion of both dose escalation and dose expansion ( approx 42 months)
Awards & highlights
Study Summary
This trial tests the safety of a new drug for advanced solid tumors. Up to 56 patients will be enrolled.
Who is the study for?
Adults with advanced solid tumors that have failed standard treatments or for whom no effective therapy exists. They must be over 18, have a life expectancy of at least 3 months, and agree to use effective birth control. Specific cancers include NSCLC, breast cancer, ovarian cancer among others. Participants need adequate organ function and measurable lesions by CT/MRI.Check my eligibility
What is being tested?
The trial is testing ALG.APV-527 in patients with advanced solid tumors likely to express the 5T4 antigen. It's an open-label study with two parts: dose escalation (about 36 patients) and dose expansion (about 20 patients), focusing on safety and optimal dosing.See study design
What are the potential side effects?
As this is a first-in-human study for ALG.APV-527, specific side effects are not yet known but may include typical reactions related to immune therapies such as fatigue, infusion-related reactions, autoimmune-like symptoms or exacerbation of underlying conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of both dose escalation and dose expansion ( approx 42 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of both dose escalation and dose expansion ( approx 42 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants with dose-limiting toxicities (DLTs)
Overall Response Rate
Secondary outcome measures
Pharmacokinetic measure- Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic measure- Peak Plasma Concentration (Cmax)
Trial Design
1Treatment groups
Experimental Treatment
Group I: ALG.APV-527Experimental Treatment1 Intervention
Part 1 Dose Escalation using ALG.APV-527 doses with a starting dose of 0.1 mg/kg and projected 6 dose cohorts will be explored to determine the MTD and/or the RP2D. Part 1 consists of a 3 + 3 dose-escalation examination of ALG.APV-527 single agent therapy in adult patients with RECIST Version1.1-measurable advanced solid tumors.
Part 2 Dose Expansion with ALG.APV-527 based on RP2D determined during Dose Escalation.
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Who is running the clinical trial?
Aptevo TherapeuticsLead Sponsor
7 Previous Clinical Trials
394 Total Patients Enrolled
Alligator Bioscience ABIndustry Sponsor
4 Previous Clinical Trials
174 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had immunotherapy or experimental drugs in the last 28 days.I have a history of brain or spinal cord disease.I have one of the listed types of cancer.I am on medication for seizures or had a stroke or mini-stroke in the last 6 months.I am taking more than 10 mg of steroids daily for a condition that is not cancer.I have a lung condition not caused by an infection.I do not have any mental health issues that would stop me from following treatment plans.I am fully active or can carry out light work.I can attend all required study visits.I have not had major surgery in the last 4 weeks.I am 18 years old or older.I have provided a recent biopsy sample for the study.I have not received any live vaccines in the last 4 weeks.I currently have an active infection.My kidney and liver are functioning well.I haven't had cancer treatment like chemotherapy, radiotherapy, or hormonal therapy in the last 14 days.My advanced cancer cannot be surgically removed, and I've tried all standard treatments.My blood counts are within a healthy range.I haven't had another type of cancer in the last 5 years.I have recovered from side effects of cancer treatment, except for hair loss, skin changes, or certain blood cell count issues.I do not have any severe or uncontrolled health conditions.I have a tumor that can be measured by CT or MRI.
Research Study Groups:
This trial has the following groups:- Group 1: ALG.APV-527
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are actively engaged in this research endeavor?
"Affirmative. According to information on clinicaltrials.gov, the trial is actively recruiting patients with an initial posting date of December 23rd 2022 and a most recent update occurring June 28th 2023. The study requires 56 participants from one single medical centre."
Answered by AI
Are there any available slots in this clinical experiment for participants?
"Affirmative, according to the records on clinicaltrials.gov, this study is still actively looking for patients. First posted on December 23rd 2022 and recently updated in June 28th 2023, it seeks 56 participants from 1 medical site."
Answered by AI
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