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

Conditions

• Solid Tumors With FGFR2 Alterations, Adult

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 3HP-2827 — DRUG
  3HP-2827 will be administered orally once daily in 28-day cycles.

Study Details

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).

Key Dates

Start date

Jun 30, 2026

Status verified

Jan 2026

Primary completion

Mar 31, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

130 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Stage I - dose escalation
  Dose escalation of 3HP-2827 in patients with advanced solid tumors.
• Experimental: Stage II - expansion
  Expansion evaluating the recommended dose and schedule of 3HP-2827 identified from Stage I.

Primary Outcome Measure

Dose Escalation Stage- incidence of adverse events (AEs) [ Time Frame: From baseline up until 28 days after the final dose ]

Central Contacts

• Shuchao Wu
  +86-21-50895559
  [email protected]

Locations (2)

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