BG-75098 + Other Agents for Cancer

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeOne Medicines

Must be taking: CDK4/6 inhibitors

Must not be taking: CDK2 inhibitors

Disqualifiers: Leptomeningeal disease, Brain metastasis, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer treatment called BG-75098 for individuals with advanced solid tumors. Researchers aim to assess the safety and tolerability of this treatment both alone and in combination with two other drugs, BGB-43395 and fulvestrant (a hormone therapy). The trial seeks participants who have tried other cancer treatments without success or cannot tolerate them, particularly if their tumors are linked to a protein called CDK2. Those with advanced cancer who have undergone previous treatments without success 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.

Do I have to stop taking my current medications for the trial?

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 this trial's treatments are likely to be safe?

Research has shown that BG-75098, when used alone, has been safe in early studies. Initial results indicate it is generally well tolerated, though specific details about side effects are not provided. Additionally, a similar drug, a CDK2 inhibitor, demonstrated manageable safety in past studies.

For the combination treatment with BG-75098, BGB-43395, and fulvestrant, safety data indicates that most side effects were mild to moderate. Related studies found that 93.8% of patients experienced side effects, mostly mild, which is common in early-stage cancer trials. This suggests that while side effects occur, they are usually not severe.

These findings suggest that both BG-75098 alone and in combination have been generally well tolerated in early studies, offering a promising outlook for their safety in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BG-75098 because it offers a fresh approach to cancer treatment by combining with other agents like BGB-43395 and fulvestrant, which could enhance its effectiveness. Unlike many standard treatments that target a single pathway, BG-75098 acts on multiple pathways, potentially overcoming resistance that often develops with existing therapies. Additionally, its unique mechanism could lead to improved outcomes for patients who haven't responded well to current options, offering hope for those with limited treatment success.

What evidence suggests that this trial's treatments could be effective for advanced solid tumors?

Research shows that BG-75098 breaks down a protein essential for cancer cell growth. Early results indicate it might help fight tumors, especially solid ones. In this trial, some participants will receive BG-75098 as monotherapy, while others will receive it with BGB-43395 and fulvestrant. Early studies suggest that when combined with BGB-43395, which targets a different protein, they might work better together against tumors. BGB-43395 alone showed promise in early breast cancer trials, being well-tolerated and effective. Overall, these findings offer hope that BG-75098, alone or with BGB-43395, could help treat advanced solid tumors. ^{1 2 4 6 7}

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 who can handle multiple treatments. Specific criteria aren't listed, but typically participants must be in good health aside from their cancer and not have conditions that could interfere with the study or pose extra risk.

Inclusion Criteria

Participants must have measurable disease as assessed by RECIST v1.1

I am fully active or restricted in physically strenuous activity but can do light work.

My organs are functioning well.

Exclusion Criteria

I have not had treatments that specifically target CDK2.

I have previously been treated with a CDK4/6 inhibitor for my condition.

I do not have active brain metastasis or leptomeningeal disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a Dose Escalation

Sequential cohorts of increasing dose levels of BG-75098 will be evaluated as monotherapy and in combination with BGB-43395 and fulvestrant

Up to approximately 2 years

Phase 1b Dose Expansion

Participants will receive BG-75098 at the recommended dose level from Phase 1a, either as monotherapy or in combination with BGB-43395 and fulvestrant

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• BG-75098
• BGB-43395
• Fulvestrant

Trial Overview The study is testing BG-75098 alone and combined with BGB-43395 and fulvestrant to see how safe they are, how the body processes them, their effects on the body, and if they shrink tumors.

How Is the Trial Designed?

Group I: Phase 1b, Cohort 2: Dose Expansion, BG-75098 Monotherapy Experimental Treatment 1 Intervention

Participants will receive BG-75098 as monotherapy at the recommended dose level from Phase 1a.

Group II: Phase 1b, Cohort 1: Dose Expansion, BG-75098 Combination Experimental Treatment 3 Interventions

Participants will receive BG-75098 at the recommended dose level from Phase 1a in combination with BGB-43395 and fulvestrant.

Group III: Phase 1a, Part B: Dose Escalation, BG-75098 Combination Experimental Treatment 3 Interventions

Sequential cohorts of increasing dose levels of BG-75098 will be evaluated in combination with BGB-43395 and fulvestrant.

Group IV: Phase 1a, Part A: Dose Escalation, BG-75098 Monotherapy Experimental Treatment 1 Intervention

Sequential cohorts of increasing dose levels of BG-75098 will be evaluated as monotherapy.

Who Is Running the Clinical Trial?

BeOne Medicines

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226349

A Study of BG-75098 Alone and in Combination With Other ... The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-00266

BGB-43395 Alone or as Part of Combination Therapies in ... This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06120283

Study Details | NCT06120283 | BGB-43395 Alone or as ... This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as ...

4. beonemedinfo.com beonemedinfo.com/CongressDocuments/Yap_BGB-43395-101_SABCS_Poster_2024.pdf

First-in-human phase 1a, dose-escalation study of BGB- ... Safety. • TEAEs occurred in 61/65 (93.8%) patients overall, and were primarily grades (gr) 1 and 2 (Table 2). • For all 65 patients, ...

5. withpower.com withpower.com/trial/phase-1-neoplasms-10-2023-ca0d6

BGB-43395 Combinations for Breast Cancer This Phase 1 medical study run by BeiGene is evaluating whether BGB-43395 will have tolerable side effects & efficacy for patients with Breast Cancer, ...

6. meddatax.com meddatax.com/clinical-trials/NCT07226349

A Study of BG-75098 Alone and in Combination With Other ... The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity ...

7. beonemedaffairs.com beonemedaffairs.com/us/7476/bgb-43395-101-trial/

BGB-43395-101 Trial BGB-43395-101 (NCT06120283) is a Phase 1a/1b, open-label, dose-escalation and expansion trial of BGB-43395, a selective CDK4 inhibitor, ...