A Study of DC05F01 in Chinese Patients with Recurrent/Refractory Ovarian Cancer and Other Advanced Solid Tumors

Sponsor
Heronova Pharmaceuticals
Study ID
NCT06873555
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DC05F01 — DRUG
    DC05F01 capsule

Study Details

This study is a multicenter, open-label, cohort expansion Phase Ib/IIa trial designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profile of DC05F01 in patients with recurrent/refractory ovarian cancer and other advanced solid tumors.

Key Dates

First listed
Mar 12, 2025
Start date
Sep 11, 2024
Status verified
Mar 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Cohort1
    Patients with recurrent/refractory ovarian cancer will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle
  • Experimental: Part A Cohort2
    Patients with limited-stage small cell lung cancer will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle
  • Experimental: Part A Cohort3
    Patients with other advanced malignant solid tumors will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle
  • Experimental: Part B
    Patients with specific advanced malignant solid tumors will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Up to 24 months ]

Central Contacts

Find similar trials

Nationwide
Ovarian cancer trialsLung cancer trialsOncology trialsGynecologic oncology trialsWomen's health trialsLung oncology trialsLung disease trials

Related Studies