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Study Summary
This trial studies a new cancer treatment for people with advanced tumors that aren't responding to other treatments.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have been diagnosed with HIV, Hepatitis B, or Hepatitis C.I have been cancer-free from any second cancer for at least 2 years.I am on long-term steroids or immunosuppressants for an autoimmune disease or other condition.I have symptoms from a brain tumor or cancer spread to the brain.I have one or more tumors that can be measured for treatment response.My cancer has spread, is getting worse, and needs treatment.I have had a bone marrow transplant.I have a serious illness that is not cancer.I have had a major organ transplant.I have acute leukemia or chronic lymphocytic leukemia (CLL).I am 18 years old or older.I agree to use effective birth control during the study.I have finished radiation for any painful or symptomatic areas before starting the study medication.I am fully active or can carry out light work.My condition did not improve with standard treatments.I have not had PD-1 inhibitors or major surgery before starting the study medication.I do not have any ongoing serious infections needing treatment.I have heart disease or an irregular heartbeat that isn't stable.I haven't had cancer treatment in the last 2 weeks.My cancer type is listed in the specific cohorts for Part B of the trial.I have either received, am not eligible for, or have declined standard cancer treatment.My cancer got worse after treatment with a checkpoint inhibitor.
- Group 1: Part A - Dose Escalation
- Group 2: Part B - Multiple Expansion Cohorts
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Has the FDA sanctioned Part A - Dose Escalation?
"Limited evidence in favor of Part A - Dose Escalation's safety and efficacy has resulted in our organization giving it a score of 1."
Are individuals currently being recruited for this research trial?
"According to the data available on clinicaltrials.gov, enrollment for this medical trial is still open. It was first posted on March 23rd 2023 and recently updated on March 30th 2023."
What is the aggregate figure of participants enrolled in this clinical research?
"Affirmative. Clinicaltrials.gov data confirms that this clinical trial is actively searching for participants, after being first posted on March 23rd 2023 and most recently updated on the 30th of the same month. The study requires 76 patients across 1 medical centre."
What is the aim of this research endeavor?
"According to GV20 Therapeutics, the primary objective of this medical trial is assessing safety and tolerability over a 36 month time period. Additionally, they are measuring Overall Survival (OS), overall response rate (ORR) and duration of response (DoR). OS refers to the time from study entry until death by any cause; ORR is defined as the proportion of responders who experience either complete or partial responses based on RECIST v1.1 criteria; DoR pertains to how long it takes for recurrence/progressive disease after initial CR or PR status."
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