BG-89894 for Cancer

Recruiting at 20 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Must not be taking: MAT2A inhibitors, PRMT5 inhibitors

Disqualifiers: Other malignancies, CNS disease, infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new cancer drug, BG-89894, to assess its safety, how the body processes it, and its potential effectiveness in treating cancer. The trial consists of two parts: the first will test different doses for safety, and the second will focus on finding the best dose for various cancer types. Individuals with advanced, hard-to-treat solid tumors that haven't responded to standard treatments might be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that BG-89894 is likely to be safe for humans?

Research shows that BG-89894, also known as SYH2039, is still under investigation to determine its safety for human use. This early-stage study examines how people react to the drug and its mechanism in the body. BG-89894 has not received FDA approval for cancer treatment, so information about its safety remains limited.

As a Phase 1 study, the drug is being tested in humans for the first time to assess safety. These early trials typically involve small groups, allowing researchers to closely monitor any side effects. Since the study is ongoing, detailed information about how well people tolerate BG-89894 is not yet available. However, this phase is crucial for identifying potential risks early. Participants in this trial will help researchers gather essential safety data on BG-89894, which is important before further testing or future approval consideration. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BG-89894 is unique because it introduces a novel mechanism of action that targets cancer cells more precisely than traditional treatments like chemotherapy or radiation. Unlike these standard options, which often affect healthy cells and can cause significant side effects, BG-89894 aims to minimize collateral damage by honing in on specific cancer cell markers. Researchers are excited about this treatment because it not only has the potential to improve effectiveness but also enhances patient safety and comfort by reducing adverse effects.

What evidence suggests that BG-89894 might be an effective treatment for cancer?

Research has shown that BG-89894, also known as SYH2039, might help treat cancer. Early studies suggest this drug can impact cancer cells by targeting specific parts of the process that aid tumor growth. Initial results indicated that BG-89894 could slow the growth of some cancers. This trial will evaluate BG-89894 in two phases: Phase 1a will focus on dose escalation and safety expansion, while Phase 1b will involve dose expansion and optimization across multiple indication-specific cohorts. Although these findings are preliminary, they offer a promising starting point for further research. More information is needed to confirm its effectiveness, but the early signs give researchers hope. ^{1 2 4 5 6}

Who Is on the Research Team?

Study Director

Principal Investigator

BeOne Medicines

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have worsened after standard therapy or lack a suitable standard treatment. Participants must have a specific genetic feature in their tumor (MTAP deletion/loss) and be able to provide tissue samples. They should be relatively active and healthy enough to perform daily activities.

Inclusion Criteria

I am willing to sign the consent form and follow the study rules.

Key

My cancer is advanced, cannot be surgically removed, and has not responded to standard treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation and Safety Expansion

Sequential cohorts of increasing dose levels of BG-89894 (SYH2039) will be evaluated as monotherapy

Approximately 18 months

Phase 1b: Dose Expansion and Optimization

Multiple indication-specific cohorts will be evaluated for safety, tolerability, and potential dose optimization of BG-89894 (SYH2039)

Approximately 18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• BG-89894

Trial Overview

The study tests BG-89894, aiming to determine its safety, tolerability, how it's processed by the body, and any preliminary effectiveness against cancer. Participants will receive this new drug over six months and will be monitored for one year post-treatment.

How Is the Trial Designed?

Group I: Phase 1b: Dose Expansion and Optimization Experimental Treatment 1 Intervention

Multiple indication-specific cohorts will be evaluated for safety, tolerability, and potential dose optimization of BG-89894 (SYH2039).

Group II: Phase 1a: Dose Escalation and Safety Expansion Experimental Treatment 1 Intervention

Sequential cohorts of increasing dose levels of BG-89894 (SYH2039) will be evaluated as monotherapy.

Who Is Running the Clinical Trial?

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Lead Sponsor

Trials

152

Recruited

22,000+

Li Chunlei

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Chief Medical Officer since 2017

Doctorate in Science (Pharmaceutical Science) from Shenyang Pharmaceutical University

Wang Huaiyu

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Chief Executive Officer since 2010

Bachelor’s degree in Microbiology and Biochemistry from Hebei University

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

BeOne Medicines

Lead Sponsor

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06568614

NCT06568614 | An Investigational Study of BG-89894 ...

This study is being done to learn more about a new drug called BG-89894 (previously known as SYH2039). Researchers want to see if the drug is safe, ...

2.

trialfinder.panfoundation.org

trialfinder.panfoundation.org/en-US/trial/listing/530296

An Investigational Study of BG-89894 Tablets in ...

Researchers want to see if the drug is safe, how well people can tolerate it, how it moves through the body, and whether it shows any early ...

3.

synapse.patsnap.com

synapse.patsnap.com/drug/b3cb1006b4a84881b84cff58166d4d63

SYH-2039 - Drug Targets, Indications, Patents

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-89894 (SYH2039) Tablets

4.

careacross.com

careacross.com/clinical-trials/trial/NCT06568614

Study of SYH2039 in Participants With Advanced Solid ...

This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD and preliminary anti-tumor activity of SYH2039 in adult ...

5.

chictr.org.cn

chictr.org.cn/showprojEN.html?proj=247544

Chinese Clinical Trial Register (ChiCTR)

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of SYH2039 Tablets in Adults ...

6.

cancer.columbia.edu

cancer.columbia.edu/cancer-types-care/clinical-trials/find-clinical-trial/phase-1-study-evaluate-safety-tolerability-pharmacokinetics-pharmacodynamics-and-preliminary-antitumor-activity-bg-89894-syh2039-tablets-patients-advanced-solid-tumors

A Phase 1 Study to Evaluate the Safety, Tolerability ...

The study drug BG-89894 is an investigational drug and has not been approved for use by the Food and Drug Administration (FDA) for the treatment of cancer. Are ...