A Clinical Study of ZL-85FA Tablets

Sponsor
Chengdu Zenitar Biomedical Technology Co., Ltd
Study ID
NCT07339748
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ZL-85FA tablets — DRUG
    ZL-85FA tablets 2.5mg, oral, once daily
  • ZL-85FA tablets — DRUG
    ZL-85FA tablets 5mg, oral, once daily
  • ZL-85FA tablets — DRUG
    ZL-85FA tablets 10mg, oral, once daily
  • ZL-85FA tablets — DRUG
    ZL-85FA tablets 15mg, oral, once daily
  • ZL-85FA tablets — DRUG
    ZL-85FA tablets 20mg, oral, once daily
  • ZL-85FA tablets — DRUG
    ZL-85FA tablets 25mg, oral, once daily
  • ZL-85FA tablets — DRUG
    ZL-85FA tablets 30mg, oral, once daily
  • ZL-85FA tablets — DRUG
    Based on the results obtained from the dose escalation phase, the necessity and dosage of the IIa phase expansion cohort will be determined by the Drug Safety Review Committee (SMC) after discussion.
  • ZL-85FA tablets — DRUG
    Based on the results obtained from the dose escalation phase, the necessity and dosage of the IIa phase expansion cohort will be determined by the Drug Safety Review Committee (SMC) after discussion.

Study Details

An open-label, multicenter phase I/IIa clinical study evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZL-85FA tablets in treating advanced solid tumors

Key Dates

First listed
Jan 14, 2026
Start date
Jun 30, 2026
Status verified
Jan 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
51 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: Dose escalation group 1
    ZL-85FA tablets 2.5mg
  • Experimental: Dose escalation group 2
    ZL-85FA tablets 5mg
  • Experimental: Dose escalation group 3
    ZL-85FA tablets 10mg
  • Experimental: Dose escalation group 4
    ZL-85FA tablets 15mg
  • Experimental: Dose escalation group 5
    ZL-85FA tablets 20mg
  • Experimental: Dose escalation group 6
    ZL-85FA tablets 25mg
  • Experimental: Dose escalation group 7
    ZL-85FA tablets 30mg
  • Experimental: Dose extension group 1
    Based on the results obtained from the dose escalation phase, the necessity and dosage of the IIa phase expansion cohort will be determined by the Drug Safety Review Committee (SMC) after discussion.
  • Experimental: Dose extension group 2
    Based on the results obtained from the dose escalation phase, the necessity and dosage of the IIa phase expansion cohort will be determined by the Drug Safety Review Committee (SMC) after discussion.

Primary Outcome Measure

Objective remission rate [ Time Frame: Up to week 96 ]

Central Contacts

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