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

3H (Suzhou) Pharmaceuticals

Status and phase: Begins enrollment in 3 months; Phase 1

Conditions: Solid Tumors With FGFR2 Alterations, Adult

Treatments: Drug: 3HP-2827

Study type: Interventional

Funder types: Industry

Identifiers

NCT06287918

3HP-2827-101

Details and patient eligibility

About

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).

Enrollment: 130 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Stage I - dose escalation

Experimental group

Description:

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

Treatment:

Drug: 3HP-2827

Stage II - expansion

Experimental group

Description:

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

Treatment:

Drug: 3HP-2827