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Trial Title: A First-in-human Study of 3HP-2827 in Patients With Unresectable or Metastatic Solid Tumors With FGFR2 Alterations

NCT ID: NCT06287918

Condition: Solid Tumors With FGFR2 Alterations, Adult

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 3HP-2827
Description: 3HP-2827 will be administered orally once daily in 28-day cycles.
Arm group label: Stage I - dose escalation
Arm group label: Stage II - expansion

Summary: 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).

Criteria for eligibility:
Criteria:
Inclusion Criteria: - The patient is willing and able to provide written informed consent and has the ability to comply with the study protocol - Men or women, age ≥ 18 years at the time of signing informed consent. - Histologically or cytologically confirmed surgically unresectable, locally advanced, metastatic solid tumor. - ECOG score is 0 or 1. - An expected survival of ≥ 12 weeks. - Evaluable or measurable disease per RECIST v1.1. - Adequate organ function, as measured by laboratory values. Exclusion Criteria: - Active brain metastases. - Have other malignancies within the past 3 years. - The toxicity from previous anti-tumor treatment has not recovered to ≤ grade 1. - Clinically significant corneal or retinal disease/keratopathy. - Clinically significant cardiovascular disorders. - Failure to swallow, chronic diarrhea, or presence of other factors affecting drug absorption. - Known to be allergic to any study drug or any of its excipients. - Any other diseases or clinical laboratory, etc that may affect the interpretation of the results, or renders the patients at high risk from treatment complications.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic

Address:
City: Phoenix
Zip: 85054
Country: United States

Facility:
Name: The University of Texas MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Start date: June 2024

Completion date: June 2028

Lead sponsor:
Agency: 3H (Suzhou) Pharmaceuticals Co., Ltd.
Agency class: Industry

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

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06287918

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