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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 36 months
Awards & highlights
Study Summary
This trial studies a new cancer treatment for people with advanced tumors that aren't responding to other treatments.
Who is the study for?
This trial is for adults with advanced solid tumors that have not responded to standard treatments. They should be expected to live at least 12 weeks, have certain lab results within specific ranges, and no active severe diseases or infections. Participants must not have had recent cancer therapies or investigational drugs and agree to use contraception.Check my eligibility
What is being tested?
The study tests GV20-0251 in patients with solid tumor malignancies that are resistant to current therapies. It's a Phase 1 trial focusing on the safety and effectiveness of this new potential treatment option for those who've exhausted approved treatments.See study design
What are the potential side effects?
Since this is an early-phase trial, exact side effects of GV20-0251 are being studied; however, common side effects may include typical reactions seen in cancer drug trials such as nausea, fatigue, allergic reactions, and possibly unique risks related to the novel nature of the drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: Establish the maximum tolerated dose and/or recommended Phase 2 dose of GV20-0251 in participants with advanced solid tumor malignancies
Part A: Evaluate the safety and tolerability of escalating doses of GV20-0251 in refractory advanced malignancy participants as defined in the protocol during dose escalation
Part B: Evaluate the Overall Response Rate of GV20-0251.
Secondary outcome measures
Part A & Part B: Evaluate the Disease Control Rate (DCR) of GV20-0251.
Part A & Part B: Evaluate the Duration of Response (DoR) of GV20-0251.
Part A & Part B: Evaluate the Overall Survival (OS) of GV20-0251.
+9 moreOther outcome measures
To preliminarily evaluate the application of biomarkers to measures of efficacy and safety.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Part B - Multiple Expansion CohortsExperimental Treatment1 Intervention
Part B consists of multiple expansion cohorts in which eligible participants will be treated at the recommended Phase 2 dose of GV20-0251 to further characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of GV20-0251 as well as to evaluate anti-tumor activity in participants with selected malignancies.
Group II: Part A - Dose EscalationExperimental Treatment1 Intervention
Part A involves a 3 + 3 dose escalation scheme to evaluate safety and dose limiting toxicities and to establish the maximum tolerated dose and/or the recommended Phase 2 dose of GV20-0251.
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Who is running the clinical trial?
GV20 TherapeuticsLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Part B - Multiple Expansion Cohorts
- Group 2: Part A - Dose Escalation
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.
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