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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 every 3 months (±14 days) after last dose, up to 2 years
Awards & highlights
Study Summary
This trial tests if a new drug is safe and effective for people with advanced solid tumors.
Who is the study for?
Adults with advanced solid tumors that are resistant or intolerant to existing treatments may join this trial. They should be in good physical condition (ECOG PS 0 or 1), have normal bilirubin levels, and adequate organ function including blood counts and liver enzymes. Women must not be pregnant, and all participants must agree to use contraception during the study.Check my eligibility
What is being tested?
The trial is testing BAL0891 alone and alongside chemotherapy drugs carboplatin or paclitaxel. It's an open-label Phase 1 study where doses of BAL0891 will gradually increase to assess safety and tolerability in patients with various types of advanced solid tumors.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion, changes in blood counts leading to increased infection risk, fatigue, possible liver enzyme alterations, digestive issues, and allergic responses specific to the drug components.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3 months (±14 days) after last dose, up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3 months (±14 days) after last dose, up to 2 years
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 Adverse Events as a Measure of Safety and Tolerability
Number of Participants With the DLT (Dose-limiting toxicity)s as a Measure of maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D)
Secondary outcome measures
Absolute neutrophil count (ANC) for all subjects
Disease control rate (DCR) for all subjects
Overall response rate (ORR) for all subjects
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Dose-escalation substudy of BAL0891 monotherapyExperimental Treatment1 Intervention
Increasing doses of BAL0891 will be administered IV on D1 and D8 Q3W (Regimen A). BAL0891 will be investigated in a dose range of 5-480 mg with Regimen A. Optionally, and based on cumulative safety, PK, and PD data, BAL0891 may be administered on D1 Q3W (Regimen B), D1 and D15 Q4W (Regimen C), or on D1, D8, and D15 Q4W (Regimen D).
Group II: Dose-escalation substudy of BAL0891 in combination with paclitaxelExperimental Treatment2 Interventions
Paclitaxel will be dosed at 70 mg/m2 on D1, D8, and D15 Q4W, with an option to use 80 mg/m2 (either instead of, or after exploring, 70 mg/m2) if the cumulative data collected at that time support a higher dose of paclitaxel.
Group III: Dose-escalation substudy of BAL0891 in combination with carboplatinExperimental Treatment2 Interventions
Carboplatin will be dosed at AUC5 Q3W, with an option to use AUC6 (either instead of, or after exploring, AUC5) if the cumulative data collected at that time support a higher dose of carboplatin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~6670
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
SillaJen, Inc.Lead Sponsor
2 Previous Clinical Trials
548 Total Patients Enrolled
SillaJen Inc.Study DirectorSillaJen, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I haven't fully recovered from major surgery within the last 4 weeks.I haven't taken steroids or immunosuppressants recently.I have a history of serious heart problems.I have had radiation on more than 25% of my bone marrow.I do not have any other serious illnesses that would make the study unsafe for me.I do not have an uncontrolled HIV infection.I don't have any major untreated side effects from previous treatments.I needed treatment to help my blood cells grow within the last 2 weeks.I've had 4 or more cancer treatments or had serious infections from them.I am not currently being treated for a severe infection with medication.My BMI is 40 or higher.I am fully active or can carry out light work.My recent lab tests show my organs are functioning well.I have active hepatitis C or B, or chronic hepatitis B meeting certain criteria.My advanced cancer does not respond to current treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Dose-escalation substudy of BAL0891 monotherapy
- Group 2: Dose-escalation substudy of BAL0891 in combination with carboplatin
- Group 3: Dose-escalation substudy of BAL0891 in combination with paclitaxel
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.
Has the Dose-escalation substudy of BAL0891 monotherapy obtained authorization from the FDA?
"As this is a Phase 1 study, meaning there are limited supporting data for efficacy and safety, we at Power assigned Dose-escalation substudy of BAL0891 monotherapy a score of 1."
Answered by AI
What are the primary aims of this research?
"This medical trial has two main goals. First, assess the Dose-limiting toxicity (DLT) and/or identify the maximum tolerated dose (MTD). Secondly, analyze patient data such as Absolute neutrophil count (ANC), Overall response rate (ORR), and Disease control rate (DCR) over a 28 day period with follow-up lasting up to 2 years."
Answered by AI
How many individuals have enlisted in the research project thus far?
"The protocol for this trial, sponsored by SillaJen Inc., necessitates 120 qualified subjects. Major locations include the Knight Cancer Institute in Portland, Oregon, and Mary Crowley Cancer Research in Dallas, Texas."
Answered by AI
Are any spots still available to join this clinical experiment?
"Affirmative, the information accessible on clinicaltrials.gov states that this clinical trial is presently recruiting participants. This study was first published on December 14th 2022 and most recently updated on March 2nd 2023. A total of 120 patients need to be enrolled from 3 medical centres in order for it to move forward."
Answered by AI
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