What is the mechanism of action of this treatment?

The most common treatments for solid tumors include chemotherapy agents like carboplatin and paclitaxel, which are being studied in combination with BAL0891. Carboplatin works by causing DNA damage that prevents cancer cells from dividing, while paclitaxel stabilizes microtubules, inhibiting cell division. BAL0891, a novel agent, is being investigated for its potential to enhance these effects. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment combinations, managing side effects, and improving overall outcomes.

What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as those involving BAL0891, carboplatin, and paclitaxel, often have a range of side effects. BAL0891's safety and tolerability are still under investigation, but typical side effects of carboplatin and paclitaxel include nausea, decreased appetite, anemia, and neuropathy. More severe side effects can include myelosuppression, leading to increased risk of infection, and hypersensitivity reactions. Patients may also experience fatigue, hair loss, and gastrointestinal issues. It is important to monitor these side effects closely and manage them in consultation with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for solid tumors that involve chemotherapeutic agents similar to those being studied with BAL0891. Carboplatin and paclitaxel are commonly used in combination for various solid tumors, including ovarian, lung, and breast cancers. For instance, the combination of carboplatin and paclitaxel is a standard treatment for advanced ovarian cancer. Additionally, paclitaxel is often used in combination with other drugs for the treatment of breast cancer and non-small cell lung cancer. These approvals highlight the established role of these chemotherapeutic agents in the management of solid tumors.

What other types of research exist?

Promising novel alternatives to BAL0891 for solid tumor patients include pembrolizumab, which has shown efficacy in various solid tumors such as non-small cell lung cancer and melanoma, and sonidegib, which is effective in advanced basal cell carcinoma. Additionally, combination therapies like pembrolizumab with lenvatinib for endometrial cancer and nivolumab with ipilimumab for renal cell carcinoma are also noteworthy options.

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BAL0891 + Chemotherapy for Solid Tumors

Phase 1

Recruiting

Research Sponsored by SillaJen, Inc.

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

No Placebo-Only Group

Summary

This trial tests a new drug, BAL0891, given to patients with severe cancer. It aims to find a safe and effective amount, both alone and with other cancer treatments. The goal is to determine the best amount that patients can handle.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months (±14 days) after last dose, up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Part 1: 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)

Part 2: Overall response rate (ORR) for all subjects

Secondary study objectives

Part 1, 2: Disease control rate (DCR) for all subjects

Part 1, 2: Overall response rate (ORR) for all subjects

Part 1, 2: Overall survival (OS) for all subjects

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part 2 : Dose expansion, cohorts 4 GC (BAL0891 + Paclitaxel)Experimental Treatment2 Interventions

BAL0891 will be administered intravenously on D1 and D15, Q4W for cohorts 4. The investigation will focus on the RP2D determined during the dose escalation phase of the study. Specifically, cohorts 4 will utilize the RP2D established in substudy 3 of the dose escalation phase.

Group II: Part 2 : Dose expansion, cohorts 3 TNBC (BAL0891 + Paclitaxel)Experimental Treatment2 Interventions

BAL0891 will be administered intravenously on D1 and D15, Q4W for cohorts 3 . The investigation will focus on the RP2D determined during the dose escalation phase of the study. Specifically, cohorts 3 will utilize the RP2D established in substudy 3 of the dose escalation phase.

Group III: Part 2 : Dose expansion, cohorts 2 GC (BAL0891 monotherapy)Experimental Treatment1 Intervention

BAL0891 will be administered intravenously on D1 and D8, Q3W for cohorts 2. The investigation will focus on the RP2D determined during the dose escalation phase of the study. Specifically, cohorts 2 will utilize the RP2D established in substudy 1 of the dose escalation phase.

Group IV: Part 2 : Dose expansion, cohorts 1 TNBC (BAL0891 monotherapy)Experimental Treatment1 Intervention

BAL0891 will be administered intravenously on D1 and D8, Q3W for cohorts 1. The investigation will focus on the RP2D determined during the dose escalation phase of the study. Specifically, cohorts 1 will utilize the RP2D established in substudy 1 of the dose escalation phase.

Group V: Part 1: Substudy 3, 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 VI: Part 1: Substudy 2, 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.

Group VII: Part 1: Substudy 1, 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

Paclitaxel

2011

Completed Phase 4

~5450

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors include chemotherapy agents like carboplatin and paclitaxel, which are being studied in combination with BAL0891. Carboplatin works by causing DNA damage that prevents cancer cells from dividing, while paclitaxel stabilizes microtubules, inhibiting cell division. BAL0891, a novel agent, is being investigated for its potential to enhance these effects. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment combinations, managing side effects, and improving overall outcomes.

Towards pathway-centric cancer therapies via pharmacogenomic profiling analysis of ERK signalling pathway.Potential molecular targets for Ewing's sarcoma therapy.