BG-C137 for Cancer

Recruiting at 40 trial locations

Overseen By Study Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BeiGene

Must not be taking: Topoisomerase inhibitors, FGFR2b-targeted ADCs

Disqualifiers: Corneal disorders, Brain metastasis, ILD, others

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

Compensation: Varies

Number of Visits: Unknown

168 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and potential effectiveness of a new cancer treatment called BG-C137, an experimental drug, in people with advanced solid tumors. Researchers seek to understand how this drug works alone and in combination with other cancer treatments. The trial seeks participants with advanced cancer that has been previously treated but still requires new options, particularly if their tumors exhibit specific genetic markers (FGFR2b). Participants should have a life expectancy of at least three months and must be willing to provide a tumor sample for testing. 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 treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking any systemic antitumor therapy at least 14 days before starting the study drug. This includes targeted therapy, immunotherapy, chemotherapy, and investigational therapy. If you're on any of these, you will need to stop them before joining the trial.

Is there any evidence suggesting that BG-C137 is likely to be safe for humans?

Research has shown that BG-C137 is being tested in humans for the first time to assess its safety. Currently in the early stages of testing, the main focus is on evaluating safety and identifying any side effects. Earlier studies conducted before human testing found that BG-C137 did not cause eye problems, even with multiple doses.

Since BG-C137 is in Phase 1, this phase typically involves determining the right dose and assessing tolerance in participants. Some unknown risks may still exist due to the early stage of testing. However, its progression to human trials indicates that initial animal tests were promising enough to warrant further exploration in humans. Participants should consult their doctors to understand these risks before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BG-C137 is unique because it offers a novel approach to cancer treatment by potentially targeting specific cancer pathways in a way that existing therapies, like chemotherapy and radiation, do not. Researchers are excited about BG-C137 because it could be more precise, minimizing damage to healthy cells and reducing side effects commonly associated with traditional treatments. Unlike standard treatments, which often take a one-size-fits-all approach, BG-C137 may allow for personalized dosing, improving efficacy and patient outcomes.

What evidence suggests that BG-C137 might be an effective treatment for cancer?

Research has shown that BG-C137 yields promising results in early tests. Initial studies demonstrated that a single dose of BG-C137 was more effective against tumors than multiple doses of another treatment, Bemarituzumab. This was particularly evident in cases with elevated levels of the protein FGFR2b, commonly found in certain cancers. In this trial, participants will receive BG-C137 in different phases: Phase 1a will evaluate increasing dose levels as monotherapy, and Phase 1b will focus on dose expansion. In another study, two patients showed some improvement, and twelve patients maintained stable disease, suggesting that BG-C137 might help control tumor growth. These early results offer hope for its effectiveness against advanced solid tumors. ^{3 5 6 7 8}

Who Is on the Research Team?

Study Director

Principal Investigator

BeOne Medicines

Are You a Good Fit for This Trial?

This trial is for people with advanced solid tumors who have tried standard treatments without success or can't tolerate them. They need to have at least one measurable tumor, a life expectancy of 3+ months, and be in good enough health to perform daily activities (ECOG status 0-1). Adequate organ function is required, and they must agree to provide tissue samples.

Inclusion Criteria

My cancer is confirmed to be advanced or has spread to other parts.

My doctor expects me to live for at least 3 more months.

I have had 1-2 treatments for my advanced cancer, or no more standard treatments are suitable for me.

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-C137 will be evaluated as monotherapy

Up to approximately 2 years

Phase 1b: Dose Expansion

Recommended Dose(s) of BG-C137 as determined from Phase 1a will be evaluated in select indications

Up to approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BG-C137

Trial Overview The study tests BG-C137, an experimental drug targeting FGFR2b proteins on cancer cells. It aims to assess the drug's safety, how well it's tolerated by patients, its behavior in the body (pharmacokinetics), its effect on tumors (pharmacodynamics), and initial effectiveness against tumors.

How Is the Trial Designed?

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

Recommended Dose(s) of BG-C137 as determined from Ph1a will be evaluated in select indications

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

Sequential cohorts of increasing dose levels of BG-C137 will be evaluated as monotherapy

Group III: Phase 1a: Combination Therapy Dose Confirmation and Safety Expansion Experimental Treatment 2 Interventions

Sequential cohorts will be evaluated to confirm the safety levels of BG-C137 in combination with other anticancer agents at selected dose levels that have been determined to be safe in Monotherapy Dose Escalation

Who Is Running the Clinical Trial?

BeiGene

Lead Sponsor

Trials

216

Recruited

32,500+

BeOne Medicines

Lead Sponsor

Published Research Related to This Trial

Basic fibroblast growth factor (bFGF) significantly enhances the proliferation of human salivary adenoid cystic carcinoma (ACC) cell line ACC-2 in a dose-dependent manner, as shown by MTT assays and increased ERK activity.

The mechanism behind bFGF's effect involves upregulation of the ERK signaling pathway and Cyclin D1, along with inhibition of p21waf/cip1, indicating potential targets for new therapies in ACC treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of basic fibroblast growth factor on the proliferation of human salivary adenoid cystic carcinoma cell line ACC-2 and extracellular signal-regulated kinase, Cyclin D1, p2waf/cip1 signaling pathway]. Ding, L., Zhu, SR., Xie, SX., et al.[2018]

Dovitinib, an oral inhibitor targeting FGF, VEGF, and PDGF receptors, was found to be tolerable and showed antitumor activity in a trial involving 20 heavily pretreated patients with advanced renal cell carcinoma, with a maximum tolerated dose of 500 mg.

Out of the participants, 2 patients achieved a partial response and 12 had stable disease, indicating that dovitinib may be effective in managing tumor growth, especially in patients who have undergone multiple prior treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of dovitinib (TKI258), an oral FGFR, VEGFR, and PDGFR inhibitor, in advanced or metastatic renal cell carcinoma. Angevin, E., Lopez-Martin, JA., Lin, CC., et al.[2022]

Reducing FGFR2 expression in human colorectal cancer (CRC) cells significantly inhibited their migration, invasion, and tumor growth, indicating its crucial role in CRC progression.

The study suggests that FGFR2 could be a promising new therapeutic target for treating colorectal cancer, as it is more highly expressed at the invasive front of tumors compared to other areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overexpressed fibroblast growth factor receptor 2 in the invasive front of colorectal cancer: a potential therapeutic target in colorectal cancer. Matsuda, Y., Ishiwata, T., Yamahatsu, K., et al.[2022]

Fibroblast growth factors (FGFs) play a crucial role in tumor growth by facilitating communication between tumor cells and their surrounding environment, which can lead to tumor progression and resistance to therapies.

Targeting the FGF/FGFR pathway presents a promising strategy for cancer treatment, although developing effective drugs has been challenging due to the complexity and redundancy of the FGF family, highlighting the potential for dual-action therapies that combine antiangiogenic and antitumor effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blocking the FGF/FGFR system as a "two-compartment" antiangiogenic/antitumor approach in cancer therapy. Giacomini, A., Chiodelli, P., Matarazzo, S., et al.[2022]

FGFR2 gene mutations and polymorphisms are linked to breast and gastric cancers, with aberrant FGFR2 signaling promoting tumor cell growth and survival, highlighting its role as a potential therapeutic target.

While FGFR2 inhibitors can be effective for treating cancers with FGFR2 mutations, using them for prevention in individuals with FGFR2 risk alleles may be harmful, as they could disrupt protective mechanisms against oxidative stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FGFR2-related pathogenesis and FGFR2-targeted therapeutics (Review). Katoh, Y., Katoh, M.[2019]

In a study of 493 gastric cancer patients, FGFR2 expression was found to be heterogeneous, with 50.9% of tumors showing no FGFR2 expression, while 40% of those with high protein expression had FGFR2 gene amplification.

Although FGFR2 expression did not correlate with overall survival in the entire cohort, it was negatively associated with survival in diffuse-type gastric cancer, indicating that FGFR2-positive diffuse-type tumors may represent a subgroup with poorer outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FGFR2 overexpression and compromised survival in diffuse-type gastric cancer in a large central European cohort. Schrumpf, T., Behrens, HM., Haag, J., et al.[2022]

The fibroblast growth factor (FGF) and its receptors (FGFRs) play a crucial role in the growth of certain human tumors, making them important targets for cancer therapy.

Strategies to inhibit FGF/FGFR signaling are being explored, including using FGFR expression to deliver targeted treatments to tumors and employing FGFs to reduce side effects of cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fibroblast growth factors in cancer: therapeutic possibilities. Jeffers, M., LaRochelle, WJ., Lichenstein, HS.[2019]

Citations

1. beonemedinfo.com beonemedinfo.com/CongressDocuments/Xu_Preclinical_BG-C137_AACR_Poster_2025.pdf

Preclinical evaluation of BG-C137, a potential first-in-class ... A single dose of BG-C137 showed superior anti-tumor efficacy compared to multiple doses of. Bemarituzumab in vivo, including in FGFR2b amplified ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0305737225000933

FGFR2b protein overexpression: An emerging biomarker in ... In a meta-analysis of 10 studies of Asian patients with advanced gastric cancer, FGFR2 protein overexpression (detected by either FGFR2b-specific or pan-FGFR2 ...

3. synapse.patsnap.com synapse.patsnap.com/drug/ad3e8c65f2ce49629346b55b3233b813

BG-C137 - Drug Targets, Indications, Patents A Phase 1a/b, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of ...

4. withpower.com withpower.com/trial/bg-c137-for-cancer-4679b

BG-C137 for Cancer · Recruiting Participants for Phase ... Out of the participants, 2 patients achieved a partial response and 12 had stable disease, indicating that dovitinib may be effective in managing tumor growth, ...

5. beonemedicines.com beonemedicines.com/science/pipeline/

BeOne Pipeline Explore BeOne Medicines, formerly BeiGene, with a cutting-edge cancer pipeline using top science and innovation to target deadly cancers.

6. aacrjournals.org aacrjournals.org/cancerres/article/85/8_Supplement_1/3778/755918/Abstract-3778-Preclinical-evaluation-of-BG-C137-a

Abstract 3778: Preclinical evaluation of BG-C137, a potential ... Here, we report the preclinical characterization of BG-C137, a first-in-class FGFR2b antibody conjugated with a topoisomerase inhibitor.

7. beonemedicines.com beonemedicines.com/clinical-trials/a-first-in-human-study-of-bg-c137-an-anti-fgfr2b-antibody-drug-conjugate-in-participants-with-advanced-solid-tumors/

BG-C137-101 A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Receptor 2b (FGFR2b) Antibody Drug Conjugate, in Participants With Advanced Solid ...

8. careacross.com careacross.com/clinical-trials/trial/NCT06625593

A FirstinHuman Study of BGC137 an AntiFGFR2b Antibody ... Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG- ...