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

NCT06873555 | Recruiting Phase 1

• 1 other identifier: SHRC-DC05F01-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Solid Tumors; Ovarian Cancer; Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Overall response rate (ORR)

  Overall response rate (ORR) based on RECIST v1.1 as assessed by the investigator

  Up to 24 months

• Progression-free Survival (PFS)

  Progression-free survival (PFS) based on RECIST v1.1 as assessed by the investigator

  Up to 24 months

Secondary Outcomes (6)

• Number of Participants With Adverse Events

  24 months

• PK profile of DC05F01

  From time zero up to 24 hours post-dose

• PK profile of DC05F01

  From time zero up to 24 hours post-dose

• PK profile of DC05F01

  From time zero up to 24 hours post-dose

• PK profile of DC05F01

  From time zero up to 24 hours post-dose

Study Arms (4)

Part A Cohort1

EXPERIMENTAL

Patients with recurrent/refractory ovarian cancer will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle

Drug: DC05F01

Part A Cohort2

EXPERIMENTAL

Patients with limited-stage small cell lung cancer will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle

Drug: DC05F01

Part A Cohort3

EXPERIMENTAL

Patients with other advanced malignant solid tumors will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle

Drug: DC05F01

Part B

EXPERIMENTAL

Patients with specific advanced malignant solid tumors will receive oral 2100 mg DC05F01 once daily, continuously, with a 4-week treatment cycle

Drug: DC05F01

Interventions

DC05F01 DRUG

DC05F01 capsule

Part A Cohort1; Part A Cohort2; Part A Cohort3; Part B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily signed the informed consent form, understanding the study and willing to follow and capable of completing all trial procedures.
• Aged ≥18 years, regardless of gender.
• Patients with locally advanced or metastatic disease, including:
• Cohort 1: Epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with FIGO stage III-IV, previously treated with platinum-based therapy and experienced disease progression or recurrence during or within 6 months (184 calendar days) after the last platinum-based treatment.
• Cohort 2: Limited-stage small cell lung cancer patients, as staged by the Veterans Administration Lung Study Group (VALG), who are not surgical candidates and have not progressed during or after at least 4 cycles of platinum-based chemotherapy combined with concurrent or sequential radiotherapy, completed within 6 weeks before the first dose.
• Cohort 3: Other solid tumors that have failed standard treatment, have no standard treatment options, or for whom standard treatment is not applicable at present.
• Cohort 1: Patients must have undergone initial or interval debulking surgery. Elevated CA125 alone without radiological or clinical evidence cannot be considered as disease progression or recurrence. Prior treatment may include bevacizumab and PARP inhibitors.
• Cohort 2: Chemotherapy regimens must include platinum agents and intravenous etoposide, followed by a radical radiotherapy regimen. Prophylactic cranial irradiation is allowed based on the investigator's judgment and local standard of care, completed within 6 weeks before the first dose.
• According to RECIST 1.1 criteria, there must be at least one measurable lesion assessed by imaging (lesions within previously irradiated areas or treated with other local therapies are generally not considered measurable unless there is documented progression) (applicable to Cohort 1 and Cohort 3).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Expected survival time of ≥3 months.
• No significant hematologic, hepatic, renal, coagulation, or cardiac function abnormalities. Laboratory test results during the screening period (no transfusions or hematopoietic growth factor support within 14 days before testing) must meet the following standards:
• Absolute Neutrophil Count (ANC) \>1.5×10\^9/L. Hemoglobin (HGB) ≥90 g/L. Platelets (PLT) \>100×10\^9/L. Total Bilirubin (TBIL) ≤1.5 mg/dL. Albumin (ALB): ≥3 g/dL. Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT)/Alkaline Phosphatase (ALP)/Gamma-Glutamyl Transferase (GGT) ≤2.5 times the upper limit of normal (ULN). If liver metastases are present, AST/ALT/ALP \< 5×ULN.
• Serum Creatinine (Scr) ≤1.5×ULN or Creatinine Clearance (CrCl) ≥60 mL/min. Prothrombin Time (PT)/Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN. Serum sodium, potassium, magnesium, calcium, and phosphate levels within normal range or deemed clinically insignificant by the investigator. Supplements to maintain normal electrolyte levels are permitted.
• Male subjects and women of childbearing potential must agree to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of the study drug. Women of childbearing potential must have a negative serum pregnancy test prior to the first dose of the study drug.

You may not qualify if:

• Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other anti-tumor treatments within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, except for:
• Nitrosoureas or mitomycin C within 6 weeks before the first dose. Oral fluorouracil or small-molecule targeted drugs within 2 weeks or 5 half-lives (whichever is shorter) before the first dose.
• Anti-tumor traditional Chinese medicine within 2 weeks before the first dose.
• Received any other investigational drug or treatment in another clinical trial within 4 weeks before the first dose.
• Underwent major organ surgery (excluding biopsy) or significant trauma within 4 weeks before the first dose, or requires elective surgery during the trial period.
• Used strong inhibitors or inducers of CYP3A4, CYP1A2, and/or CYP2D6 within 14 days or 5 half-lives (whichever is shorter) before the first dose.
• Previous allogeneic hematopoietic stem cell or bone marrow transplantation, or previous solid organ transplantation, or current use of immunosuppressive drugs or anti-rejection medications.
• Allergy to any active or inactive ingredient of the study drug.
• Adverse effects from prior anti-tumor treatments have not resolved to ≤Grade 1 according to CTCAE v5.0 (except for toxicities deemed not to pose a safety risk by the investigator, such as alopecia, Grade 2 peripheral neuropathy, or stable hypothyroidism managed with hormone replacement).
• Active hepatitis B (HBsAg positive with HBV-DNA \> lower limit of detection at the study center); hepatitis C virus infection (HCV-RNA \> lower limit of detection at the study center); positive HIV antibody test; positive Treponema pallidum antibody test.
• Presence of brain metastases or leptomeningeal metastases during the screening period or previously.
• Presence of uncontrolled third-space effusions (e.g., large pleural effusions and/or ascites) as judged by the investigator.
• Severe cardiovascular diseases, including but not limited to:
• Serious cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III degree atrioventricular block, etc.
• Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other Grade 3 or higher cardiovascular events within 6 months before the first dose.

Sponsors & Collaborators

• Heronova Pharmaceuticals: lead

Study Sites (2)

The Fisrt Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233004, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Kang Ren

CONTACT

+86-13269683867; renkang@dcpc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 12, 2025
• Study Start: September 11, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)