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PARP Inhibitor
2X-121 + Dovitinib for Cancer
Phase 1
Recruiting
Research Sponsored by Allarity 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 evaluated after up to approximately 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new cancer drug to see how well it works and what side effects it has.
Who is the study for?
Adults with advanced solid tumors who have recovered from previous treatments, have a life expectancy of at least 3 months, and meet certain blood and organ function criteria. They must not be on other cancer therapies or have active infections or significant heart issues. Participants need to agree to use contraception and cannot be pregnant or breastfeeding.
What is being tested?
The trial is in two parts: first, finding the highest dose of 2X-121 that patients can tolerate without severe side effects (monotherapy), then determining the maximum tolerated dose of dovitinib combined with 2X-121. It will assess safety, how the body processes these drugs, and their effectiveness against tumors.
What are the potential side effects?
Potential side effects are not specified but may include typical reactions to cancer medications such as nausea, fatigue, blood count changes, liver function alterations, and possibly others depending on individual tolerance levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluated after up to approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluated after up to approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determination of the MTD of 2X-121 monotherapy.
Determination of the MTD of dovitinib given in combination with 2X-121 (MTD).
Secondary study objectives
To evaluate overall survival (OS) of 2X-121 monotherapy (Part 1) and in combination with dovitinib (Part 2).
To evaluate progression free survival (PFS) of 2X-121 monotherapy (Part 1) and in combination with dovitinib (Part 2).
To evaluate the duration of overall response (DOR) of 2X-121 monotherapy (Part 1) and in combination with dovitinib (Part 2).
+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: 2X-121 Monotherapy and Dovitinib in Combination with 2X-121 in Patients with Advanced Solid TumorsExperimental Treatment1 Intervention
Determine the maximum tolerated dose (MTD) of 2X-121 monotherapy given twice daily (BID) and determine the MTD of dovitinib given in combination with 2X-121 (MTD) in patients with advanced solid tumors.
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Who is running the clinical trial?
Allarity TherapeuticsLead Sponsor
7 Previous Clinical Trials
288 Total Patients Enrolled
Amarex Clinical ResearchOTHER
26 Previous Clinical Trials
1,642 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from my last surgery or cancer treatment side effects.I am not on any cancer treatments except for non-cancer related medications like insulin.I have a bleeding or clotting disorder or am on blood thinners.I am currently on antibiotics for an infection.I have an active heart condition.I have active hepatitis B or C.It has been over 2 weeks since my last surgery or treatment with G-CSF or GM-CSF.I need immediate relief treatment for my condition.My doctor agrees that my health allows me to join this study safely.I can take pills and do not have uncontrolled stomach issues.I understand the study and its risks.I am 18 years old or older.I am fully active and can carry on all my pre-disease activities without restriction.My cancer was confirmed through tissue or cell testing.I am not pregnant or breastfeeding.My brain condition is stable, and I've been on a steady or lower dose of steroids for over a week.I haven't had cancer, except for skin (non-melanoma) or cervical cancer, in the last 5 years.I am not pregnant or will use birth control during and after the study.
Research Study Groups:
This trial has the following groups:- Group 1: 2X-121 Monotherapy and Dovitinib in Combination with 2X-121 in Patients with Advanced Solid Tumors
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.