3HP-2827 for Cancer

Not yet recruiting at 1 trial location

Overseen By Shuchao Wu

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: 3H (Suzhou) Pharmaceuticals Co., Ltd.

Disqualifiers: Brain metastases, Other malignancies, Cardiovascular disorders, 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 explores a new treatment called 3HP-2827 for individuals with advanced solid tumors that cannot be surgically removed or have spread. The trial aims to assess the safety and effectiveness of this treatment and to understand its behavior in the body. It consists of two parts: determining the right dose and then testing that dose in more participants. Suitable candidates have tumors with FGFR2 changes, cannot undergo surgery to remove their tumors, and have a life expectancy of at least 12 weeks. 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 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 3HP-2827 is likely to be safe for humans?

Research shows that 3HP-2827 is under study to assess its safety and tolerability. This treatment targets tumors with specific changes in the FGFR2 gene. Earlier studies tested 3HP-2827 to understand its effects on the body, including potential side effects.

Currently, information about the safety of 3HP-2827 in humans remains limited. As this trial is in its early stages, researchers continue to explore its safety. Early trials often focus on determining the right dose that people can tolerate without excessive side effects.

While there is hope that 3HP-2827 will be well-tolerated, researchers are still working to confirm its safety in humans. Participants in such trials help gather crucial data to ensure treatments are as safe as possible. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about 3HP-2827 because it introduces a novel approach to treating advanced solid tumors. Unlike traditional chemotherapy, which often targets rapidly dividing cells indiscriminately, 3HP-2827 is designed to target specific pathways involved in tumor growth, potentially reducing side effects and increasing effectiveness. This targeted mechanism may offer new hope for patients with advanced solid tumors who have limited options with current therapies.

What evidence suggests that 3HP-2827 might be an effective treatment for solid tumors?

Research shows that 3HP-2827 is designed to block FGFR2, a protein that can be overly active in some cancers. In lab studies, this drug demonstrated strong effects against tumors in mice with FGFR2-related cancers, such as stomach cancer. These studies suggest that 3HP-2827 could help shrink tumors with FGFR2 changes. In this trial, participants will receive 3HP-2827, with Stage I focusing on dose escalation and Stage II on expansion to evaluate the recommended dose and schedule. The drug is still being tested in humans, so more information is needed to confirm its effectiveness. However, early results are promising for patients with these specific types of cancer. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors that can't be removed by surgery or have spread, and these tumors must have specific genetic changes called FGFR2 alterations. The exact eligibility criteria are not provided here.

Inclusion Criteria

The patient is willing and able to provide written informed consent and has the ability to comply with the study protocol

My organ functions are within normal ranges according to recent tests.

An expected survival of ≥ 12 weeks

Exclusion Criteria

Known to be allergic to any study drug or any of its excipients

I do not have serious eye diseases affecting the cornea or retina.

I have a serious heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Dose escalation of 3HP-2827 in patients with advanced solid tumors

8-12 weeks

Expansion

Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 3HP-2827

Trial Overview The study tests a new medication, 3HP-2827, to see how safe it is and how well it works against cancer with certain genetic traits. It's done in two parts: first finding the right dose (Stage I) and then seeing its effect on more people (Stage II).

How Is the Trial Designed?

Group I: Stage II - expansion Experimental Treatment 1 Intervention

Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I.

Group II: Stage I - dose escalation Experimental Treatment 1 Intervention

Dose escalation of 3HP-2827 in patients with advanced solid tumors.

Who Is Running the Clinical Trial?

3H (Suzhou) Pharmaceuticals Co., Ltd.

Lead Sponsor

Trials

2

Recruited

260+

Published Research Related to This Trial

A review of 10 trials with 3763 cancer patients found that the safety profiles of approved PARP inhibitors (olaparib, rucaparib, niraparib, talazoparib) are comparable regarding serious adverse events and treatment discontinuation due to adverse events.

However, talazoparib was associated with a higher risk of treatment interruption and dose reduction due to adverse events, while niraparib showed a trend towards lower risk, highlighting the need for careful monitoring and dose adjustments to optimize treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative safety and tolerability of approved PARP inhibitors in cancer: A systematic review and network meta-analysis. Cai, Z., Liu, C., Chang, C., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06378593

A Study of 3HP-2827 in Treatment of Unresectable or ... The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20572259

A First-in-human Study of 3HP-2827 in Patients With ... The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06287918

A First-in-human Study of 3HP-2827 in Patients With ... Dose escalation of 3HP-2827 in patients with advanced solid tumors. Intervention/Treatment, Drug : 3HP-2827. 3HP-2827 will be administered orally once daily ...

4. withpower.com withpower.com/trial/3hp-2827-for-cancer-f3779

3HP-2827 for Cancer · Info for Participants The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of ...

5. researchgate.net researchgate.net/publication/379204613_Abstract_1965_3HP-2827-high_selective_inhibitor_of_FGFR2_a_best-in-class_therapy_for_FGFR2-driven_solid_tumors

Abstract 1965: 3HP-2827-high selective inhibitor of FGFR2, ... In vivo, 3HP-2827 demonstrates potent antitumor activity in cell- and patient-derived xenograft mouse models, including FGFR2-amplified gastric cancer, FGFR2- ...

6. aacrjournals.org aacrjournals.org/cancerres/article/84/6_Supplement/1965/738272/Abstract-1965-3HP-2827-high-selective-inhibitor-of

Abstract 1965: 3HP-2827-high selective inhibitor of FGFR2, a ... We designed 3HP-2827, a highly selective and potent small molecule inhibitor of FGFR2, to treat solid tumors harboring FGFR2 alterations.