3HP-2827 for Cancer

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

130 Participants Needed

Trial Summary

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.

What safety data exists for the treatment 3HP-2827 (also known as NVP-BEZ235) in humans?

The research on NVP-BEZ235, a dual PI3K/mTOR inhibitor, does not provide specific safety data for humans, but it has been studied for its potential to enhance the effectiveness of radiotherapy in head and neck cancer cell lines. ^{1 2 3 4 5}

What is the purpose of this trial?

The study is being conducted to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 3HP-2827 in the treatment of unresectable or metastatic solid tumors with FGFR2 alterations. Patients will be enrolled in two stages: dose escalation stage (Stage I) and expansion stage (Stage II).

Eligibility Criteria

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

An expected survival of ≥ 12 weeks

Evaluable or measurable disease per RECIST v1.1

Exclusion Criteria

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

I have a serious heart condition.

I have issues swallowing, chronic diarrhea, or other conditions affecting how my body absorbs drugs.

Timeline

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Dual PI3K/mTOR Inhibitor NVP-BEZ235 Enhances Radiosensitivity of Head and Neck Squamous Cell Carcinoma (HNSCC) Cell Lines Due to Suppressed Double-Strand Break (DSB) Repair by Non-Homologous End Joining. [2020]

2. Japan pubmed.ncbi.nlm.nih.gov

[Combined CDDP-THP-PEP chemotherapy (PTP therapy) for head and neck squamous cell carcinoma--a group study]. [2013]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Comparative safety and tolerability of approved PARP inhibitors in cancer: A systematic review and network meta-analysis. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of Targeting PIK3CA Mutations in Head and Neck Squamous Cell Carcinoma. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Use of nonsteroidal anti-inflammatory drugs predicts improved patient survival for PIK3CA-altered head and neck cancer. [2020]