FGFR Inhibitor for Advanced Cancer

Not currently recruiting at 1 trial location

Overseen By yuping Luo, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: 3D Medicines (Beijing) Co., Ltd.

Must not be taking: CYP3A4 inhibitors, CYP2C8 inhibitors, CYP3A4 inducers, Warfarin

Disqualifiers: Eye diseases, Active infections, Cardiovascular diseases, 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 aims to test the safety and early effectiveness of a new treatment called 3D185, an FGFR inhibitor, for advanced solid tumors unresponsive to standard treatments. Participants will begin with single doses to determine the optimal dose, then proceed with daily dosing. This trial may suit individuals with advanced solid tumors who have exhausted other treatments and meet specific medical criteria for safe participation. 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 this new treatment.

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

The trial requires that you stop taking certain medications before starting. Specifically, you must not have taken any investigational products, anti-tumor therapies, or certain strong inhibitors or inducers within a specified period before the first dose. It's best to discuss your current medications with the trial team to see if any need to be paused.

Is there any evidence suggesting that 3D185 is likely to be safe for humans?

Research has shown that FGFR inhibitors, such as 3D185, are generally safe for people with advanced solid tumors. Studies indicate that most patients tolerate these treatments well. The side effects are typically mild and manageable, including mild nausea, fatigue, or changes in taste. Importantly, these effects usually do not necessitate stopping the treatment. Overall, early trials suggest FGFR inhibitors are a promising and safe option for cancer treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about 3D185 because it targets the FGFR (Fibroblast Growth Factor Receptor), which plays a key role in the growth and spread of certain advanced cancers. Unlike many existing treatments that may not specifically target FGFR, 3D185 offers a more precise approach, potentially leading to better outcomes and fewer side effects. This treatment is also unique due to its oral administration, providing a more convenient option compared to some current therapies that require intravenous delivery. Overall, the potential for improved targeting of cancer cells and the ease of use make 3D185 a promising new option in cancer treatment.

What evidence suggests that 3D185 might be an effective treatment for advanced cancer?

Research has shown that 3D185, the investigational treatment in this trial, offers promise for advanced cancers. It targets specific proteins—FGFR1, FGFR2, and FGFR3—that often contribute to cancer growth. Previous studies found 3D185 effective in blocking these proteins. This type of treatment has demonstrated some success in other research, with patients experiencing about 3.2 months without cancer progression. Although the response rate varies, this suggests potential for controlling cancer growth, especially in patients without specific genetic changes. Overall, 3D185's ability to target these proteins makes it a hopeful option for treating advanced tumors. ^{3 5 6 7 8}

Who Is on the Research Team?

Di Zhu

Principal Investigator

3D Medicines (Beijing) Co., Ltd.

Are You a Good Fit for This Trial?

Adults with advanced solid tumors who've tried standard treatments without success or can't tolerate them. They need to be relatively healthy, with a life expectancy of at least 12 weeks, good organ function, and no major surgery in the last month. They must not have certain heart conditions, uncontrolled high blood pressure, active infections like hepatitis B or C, recent biliary tract procedures that are unresolved, gastrointestinal issues affecting drug absorption, symptomatic brain metastases unless stable and untreated for at least a month.

Inclusion Criteria

My kidney function is within the required range and my urine protein is low.

CBC: neutrophils ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 9.0 g/dL.

Subjects must have at least one evaluable lesion (according to RECIST 1.1, see Appendix 1).

Exclusion Criteria

I had treatment for a blocked bile duct within the last 14 days or still need medication for it.

I do not have stomach or bowel problems that affect how I absorb medication.

I have had eye conditions affecting the retina.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation Treatment

Participants receive a single oral dose of 3D185 followed by a 7-day washout period, then consecutive daily doses until disease progression, death, unacceptable toxicity, or withdrawal of consent

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

What Are the Treatments Tested in This Trial?

Interventions

• 3D185

Trial Overview The trial is testing the safety and effectiveness of a new cancer drug called 3D185. It's designed to inhibit specific proteins (FGFR1-3) involved in tumor growth. This early-phase study will see how patients handle different doses and look for any signs that it might shrink their tumors.

How Is the Trial Designed?

Group I: Open-Label, Dose-Escalation Experimental Treatment 1 Intervention

The starting dose in this dose-escalation study is 50 mg, and the preset 6 dose-escalation cohorts are 50 mg, 100 mg, 150 mg, 200 mg, 250 mg, and 300 mg, respectively. This study adopts an i3+3 method for dose escalation. All subjects in each cohort will receive a single oral dose of 3D185, followed by a 7-day washout period (i.e. single-dose PK study period). Then, subjects will receive consecutive daily doses (Once daily \[QD\], 28 days/cycle) until disease progression, death, unacceptable toxicity, or withdraw of informed consent, whichever comes first

Who Is Running the Clinical Trial?

3D Medicines (Beijing) Co., Ltd.

Lead Sponsor

Trials

3

Recruited

90+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6704710/

Preclinical evaluation of 3D185, a novel potent inhibitor ... Results. 3D185 significantly inhibited the kinase activity of FGFR1/2/3 and CSF-1R, with equal potency and high selectivity over other kinases.

2. ascopubs.org ascopubs.org/doi/10.1200/PO-24-00896

Safety and Activity of Fibroblast Growth Factor Receptor ... After a median follow-up time of 20 months (95% CI, 12.9 to 71.8), median progression-free survival (mPFS) was 3.2 months (95% CI, 1.9 to 4.6) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10466438/

Current progress in cancer treatment by targeting FGFR ... The objective response rate (ORR) was reported to be 4.5% in the FGFR2-mutated group and 16.1% in the group without FGFR2 mutations. In patients ...

4. asco.org asco.org/abstracts-presentations/ABSTRACT426880

A meta-analysis of phase II clinical trials. Outcome data were available for all eight studies, comprising 562 patients with FGFR-positive advanced cholangiocarcinoma who received FGFR-targeted treatment ...

5. jhoonline.biomedcentral.com jhoonline.biomedcentral.com/articles/10.1186/s13045-024-01558-1

Targeting FGFR for cancer therapy Carrying FGFR amplification is associated with adverse clinical outcomes. FGFR1 amplification was significantly associated with shorter overall ...

6. nature.com nature.com/articles/s41598-025-11411-1

Data mining and safety analysis of FGFR tyrosine kinase ... This study leveraged post-marketing data from the FDA Adverse Event Reporting System (FAERS) between the second quarter of 2019 and the third quarter of 2024

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40239140/

Safety and Activity of Fibroblast Growth Factor Receptor ... FGFRi are effective treatment strategies for patients with advanced solid tumors harboring FGFR alterations, with manageable toxicities in most patients.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2666379123003713

Clinical development and management of adverse events ... Clinical studies for each of the FGFR inhibitors were reviewed for safety and tolerability data to provide an overview of AEs requiring dose ...