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A Monotherapy in Subjects With Advanced Solid Tumors

NCT04221204 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-25

No results posted yet for this study

Summary

A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics Profiles, and Preliminary Efficacy of 3D185 Monotherapy in Subjects with Advanced Solid Tumors

Conditions

  • Solid Tumor, Adult

Interventions

DRUG

Highly selective FGFR1-3 inhibitor

All subjects in each cohort will receive a single oral dose of 3D185, followed by a 7-day washout period (i.e. single-dose PK study period). Then, subjects will receive consecutive daily doses (Once daily \[QD\], 28 days/cycle) until disease progression, death, unacceptable toxicity, or withdraw of informed consent, whichever comes first. The dose limiting toxicity (DLT) evaluation period includes the single-dose PK study period and the first treatment cycle (within 35 days after the first dose). The enrolled subjects will be sequentially assigned to the planned dose cohorts according to the protocol and receive 3D185 treatment to observe the occurrence of DLT.

Sponsors & Collaborators

  • 3D Medicines (Beijing) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Di Zhu · 3D Medicines (Beijing) Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04221204 on ClinicalTrials.gov