84 Participants NeededMy employer runs this trial

BG-C0979 for Solid Tumors

Recruiting at 16 trial locations
SD
Overseen ByStudy Director
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and tolerability of a new drug, BG-C0979, for treating certain advanced solid tumors. Researchers are testing BG-C0979 both alone and in combination with another drug, tislelizumab (an immunotherapy), to evaluate its effectiveness against cancer. The study also examines how the body processes BG-C0979 and its preliminary effects on tumors. Individuals with advanced solid tumors that cannot be surgically removed and have not responded to other treatments may be suitable candidates for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether 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?

Earlier studies found BG-C0979 to be generally safe for patients with advanced solid tumors. Most side effects were mild to moderate, causing discomfort for some patients but not severe for most.

When combined with tislelizumab, more safety information becomes available. Tislelizumab is already used in other treatments and has approval in the European Union for certain cancers, such as lung and head and neck cancers. This approval indicates that tislelizumab's side effects are known and manageable.

BG-C0979 is currently in Phase 1 trials, meaning the treatment is still under careful safety monitoring in humans. Phase 1 trials are the first step in testing a new drug, focusing on safety and patient tolerance. Although this phase is early, research so far suggests BG-C0979 is generally safe for continued study in clinical trials.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about BG-C0979 for solid tumors because it represents a novel approach compared to existing treatments. While most current therapies target specific proteins on tumor cells, BG-C0979 is designed to work by engaging a different molecular pathway, which could potentially overcome resistance seen with other treatments. Additionally, in its combination with tislelizumab, an immune checkpoint inhibitor, BG-C0979 could enhance the immune system's ability to attack cancer cells more effectively. This dual approach could offer a more robust solution for patients with tough-to-treat tumors.

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

Research has shown that BG-C0979 is a new cancer drug targeting a protein called ADAM9, found in many solid tumors. This drug delivers a toxic substance directly to cancer cells while sparing healthy ones. Early studies suggest that this targeted approach has shown promise in shrinking tumors.

In this trial, some participants will receive BG-C0979 as monotherapy, while others will receive a combination of BG-C0979 and tislelizumab. Tislelizumab, which helps the immune system fight cancer, has significantly increased overall survival and response rates in previous studies. Together, BG-C0979 and tislelizumab may effectively attack cancer cells and enhance the body's immune response against them.14678

Who Is on the Research Team?

SD

Study Director

Principal Investigator

BeOne Medicines

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that can't be removed by surgery. Participants must have at least one tumor that can be measured, good organ function, and be in generally good physical condition. Some groups require prior treatment; others are for those who haven't had systemic therapy yet.

Inclusion Criteria

* Participants must have ≥ 1 measurable lesion as assessed by RECIST v1.1.
I am fully active or have only minor physical limitations.
My organs are working well enough for treatment.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation

Participants receive increasing doses of BG-C0979 as monotherapy to determine the maximum tolerated dose

Up to approximately 10 months

Phase 1a: Safety Expansion

Participants receive BG-C0979 at selected safe dose levels for further evaluation

Up to approximately 24 months

Phase 1b: Dose Optimization and Expansion

Participants receive BG-C0979 as monotherapy in dose optimization and expansion phases

Up to approximately 24 months

Phase 1b: Combination Therapy Expansion

Participants receive BG-C0979 in combination with tislelizumab in select tumor types

Up to 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-C0979
  • Tislelizumab

Trial Overview

The study is testing a new drug called BG-C0979 alone or combined with another drug, tislelizumab, to see how safe they are and if they help shrink tumors. The trial has different phases to find the best dose and check early signs of effectiveness.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Phase 1b, Part B: Combination Therapy ExpansionExperimental Treatment2 Interventions
Group II: Phase 1b, Part A: Monotherapy Dose Optimization and Dose ExpansionExperimental Treatment1 Intervention
Group III: Phase 1a: Monotherapy Safety ExpansionExperimental Treatment1 Intervention
Group IV: Phase 1a: Monotherapy Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

BeOne Medicines

Lead Sponsor

Citations

A Multicenter, Open-Label, Phase 1a/b First-in-Human ...

... BG-C0979 in Patients With Selected Advanced Solid Tumors. Condition: Advanced Solid Tumor. Study Type: Interventional. Clinical Trials ...

A First-in-Human Study of BG-C0979 in Adults ...

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 ...

BG-C0979 for Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 ...

BeOne Medicines launches ADAM9-targeted ADC into first ...

BeOne Medicines initiates a Phase I study for BG-C0979, a first-in-class ADAM9-targeted ADC with a TOPO1 payload for advanced solid tumors.

Global clinical development pipeline

BG-C0979. ADAM9 ADC. • 101 Solid tumors. BG-T187. EGFR x MET x MET tsAb. • 101 Solid tumors. BG-C0902. EGFR x MET x MET tsADC. • 101 Solid tumors. BGB-58067.

A First-in-Human Study of BG-C0979 in Adults With Advanced ...

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 ...

A First-in-Human Study of BG-C0979 in Adults With Advanced ...

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of BG-C0979 ...

BG-C0979 - Drug Targets, Indications, Patents

... Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-C0979 in Patients With Selected Advanced Solid Tumors. 100 ...