BG-C0902 for Cancer

Recruiting at 1 trial location

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Must not be taking: Corticosteroids, Anticonvulsants, others

Disqualifiers: Severe allergies, Brain metastasis, ILD, others

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

Compensation: Varies

Number of Visits: Unknown

63 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BG-C0902 for individuals with advanced solid tumors unresponsive to other treatments. The goal is to assess the safety and tolerability of this treatment and its potential to shrink tumors. The study consists of two parts: first, determining a safe dose, and then testing that dose in more participants. This trial seeks participants whose cancer cannot be surgically removed and who have no other treatment options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that BG-C0902 is likely to be safe for humans?

Research into BG-C0902 remains in the early stages. As a first-in-human study, it primarily focuses on assessing the treatment's safety and tolerability. This Phase 1 trial marks the first time this treatment is tested in humans.

Consequently, detailed information on side effects or safety is limited. In Phase 1 studies, researchers closely monitor participants to determine the safest dose and identify any side effects. The treatment undergoes careful testing, but potential risks are not yet fully understood.

Joining a trial like this is an important decision and often involves risks that are not fully known. Always consult with a doctor to determine if this is the right choice. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BG-C0902 is unique because it works as a monotherapy with the potential to target specific cancer cells more precisely than traditional chemotherapy. Traditional treatments often involve broad-spectrum chemotherapy, which can harm both cancerous and healthy cells, leading to significant side effects. BG-C0902 aims to minimize these side effects by escalating doses to find the most effective and safest level for patients. Researchers are excited about its potential to target tumors more accurately, possibly leading to better outcomes with fewer side effects.

What evidence suggests that BG-C0902 might be an effective treatment for cancer?

Research suggests that BG-C0902 could help treat advanced solid tumors. This treatment blocks two proteins, EGFR and MET, which often contribute to cancer growth. By inhibiting these proteins, BG-C0902 might halt or even shrink tumors. The drug also links to a substance that can damage cancer cell DNA, leading to cell death. Early lab studies have shown promising results, indicating potential effectiveness in humans. Although human study data is limited, current research appears promising. Participants in this trial will receive BG-C0902 in different phases to evaluate its safety and effectiveness. ^{1 5 6 7 8}

Who Is on the Research Team?

Study Director

Principal Investigator

BeiGene

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that can't be removed by surgery or treated with curative intent, and who have no other treatment options or can't tolerate them. They must have at least one measurable tumor, be in relatively good health (ECOG ≤ 1), and have proper organ function. Participants need to provide a tissue sample of their tumor and agree to use effective birth control.

Inclusion Criteria

I agree to use effective birth control and not donate sperm during and for 4 months after the study.

My recent tests show my organs and bone marrow are functioning well.

I have at least one tumor that can be measured.

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-C0902 will be evaluated as monotherapy to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD)

Approximately 24 months

Phase 1b: Dose Expansion

The recommended dose(s) for expansion (RDFE) for BG-C0902 from Part 1 will be evaluated in selected tumors

Approximately 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BG-C0902

Trial Overview The study tests BG-C0902, an antibody targeting EGFR/MET linked to a TOPO1 inhibitor for cancer therapy. It's conducted in two phases: Phase 1a determines the safe dosage and Phase 1b expands on this dose. The goal is to evaluate safety, how the body processes the drug, its effects on tumors, and early signs of effectiveness.

How Is the Trial Designed?

Group I: Phase 1b: Dose Expansion of BG-C0902 Experimental Treatment 1 Intervention

The recommended dose(s) for expansion (RDFE) for BG-C0902 from Part 1 will be evaluated in selected tumors.

Group II: Phase 1a: Dose Escalation and Safety Expansion of BG-C0902 Experimental Treatment 1 Intervention

Sequential cohorts of increasing dose levels of BG-C0902 will be evaluated as monotherapy.

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07181681

A First-in-Human Study of BG-C0902 Alone and ... This study is a first-in-human (FIH), Phase 1a/1b study of BG-C0902, a fully humanized anti-epidermal growth factor receptor (EGFR) and ...

2. tipranks.com tipranks.com/news/company-announcements/beone-medicines-launches-promising-study-on-bg-c0902-for-advanced-solid-tumors

BeOne Medicines Launches Promising Study on BG ... ' The study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C0902, an ...

3. linkedin.com linkedin.com/posts/pandayu_beigenes-egfrcmet-adc-initiates-phase-i-activity-7374730640224796672-6gC5

BeiGene focuses on ADCs, including dual-target EGFR ... ... BG-C0902 is an EGFR/cMET/cMET trispecific #ADC, and it also marks BeiGene's first dual-target ADC to enter the clinical stage. #FINANCE ...

4. sec.gov sec.gov/Archives/edgar/data/1727196/0001171843-19-001683.txt

0001171843-19-001683.txt ... cancer patients in a manner consistent with preclinical data, and the ... outcomes x Translational/preclinical data support myostatin as a drug target ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9697974/

Nanotherapeutics Plus Immunotherapy in Oncology This review will focus on combining nanotherapeutics and immunotherapies together, how they can dually optimize each other to face such limits.

6. ctv.veeva.com ctv.veeva.com/study/a-first-in-human-study-of-bg-c0902-alone-and-in-combination-with-other-therapeutic-agents-in-patient

A First-in-Human Study of BG-C0902 Alone and in ... The study aims to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-C0902 in ...

7. research.monash.edu research.monash.edu/en/projects/a-phase-1ab-study-to-investigate-the-safety-tolerability-pharmaco/

A Phase 1a/b Study to Investigate the Safety, Tolerability ... A Phase 1a/b Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-C0902, ...

8. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/ONC/pressreleases/35741709/beone-medicines-launches-promising-study-on-bg-c0902-for-advanced-solid-tumors/

BeOne Medicines Launches Promising Study on BG ... ' The study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-C0902, an ...