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Not yet recruitingNCT06055348Updated Sep 26, 2023

SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer

A Phase 1/2 interventional study of SC0191 and Gemcitabine in Serous Ovarian Cancer and Advanced Ovarian Cancer, sponsored by Biocity Biopharmaceutics Co., Ltd.. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Biocity Biopharmaceutics Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
112
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study summary

A phase Ib/II clinical study on the safety, pharmacokinetic characteristics, and preliminary efficacy of SC0191 combination chemotherapy in patients with advanced ovarian cancer.

Read the detailed description

The phase 1b/2,multicenter, open-label study, contains 2 parts.

Part 1 Dose Escalation of SC0191 combination chemotherapy:

Part 1 will estimate the RP2D in dose escalation cohorts in patients withadvanced ovarian cancer.

Part 2 Dose Expansion of SC0191 plus Chemotherapy.

02

Conditions studied

  • Serous Ovarian Cancer
  • Advanced Ovarian Cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Histologically or cytologically confirmed advanced ovarian cancer that has failed or intolerant or not applicable to standard treatment (applicable to the dose escalation phase of stage Ib);
  2. Histologically or cytologically confirmed advanced high-grade serous ovarian cancer, platinum-resistant or platinum-refractory recurrent ovarian cancer (applicable to the dose expansion phase of stage II);
  3. There is at least one measurable lesion that meets the definition of RECIST 1.1;
  4. Voluntarily participate in clinical trials and sign informed consent;
  5. Age ≥18 years;
  6. ECOG score of 0 to 1;
  7. Predicted life expectancy ≥3 months;
  8. Adequate bone marrow, liver biochemistry, renal function, and coagulation status.
  9. Female patients who agree to use adequate contraceptive measures.

Exclusion criteria

Exclusion Criteria:

  1. Received chemotherapy, radiotherapy, immunotherapy or biological therapy, steroid therapy or other investigational drugs \<28 days prior to the first dose of study treatment.
  2. Patients who have not fully recovered from surgery according to the investigator's judgment.;
  3. Patients who have previously received WEE1 inhibitor treatment;
  4. Unresolved AEs or toxicities due to previous treatments;
  5. Patients with contraindications or a history of severe allergies to gemcitabine or paclitaxel;
  6. Known malignant CNS disease other than neurologically stable, treated brain metastases;
  7. Other medical conditions or systemic diseases not suitable to participate;
  8. The need for long-term therapeutic doses of anticoagulant or antiplatelet drugs;
  9. Received CYP3A4 moderate or strong inhibitors or CYP3A4 moderate or strong inducers within 14 days;
  10. Pregnant or lactating women.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
112 participants (estimated)

Study arms

  • Experimental
    Arm A (SC0191 + Gemcitabine).

    SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle. Gemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.

    Drug: SC0191 · Drug: Gemcitabine

  • Experimental
    Arm B (SC0191 + Paclitaxel).

    SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle. Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.

    Drug: SC0191 · Drug: Paclitaxel

Interventions

  • DrugSC0191

    SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle.

    Also known as: Study drug

  • DrugGemcitabine

    Gemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.

    Also known as: Gemcitabine Injection

  • DrugPaclitaxel

    Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.

    Also known as: Taxol

05

What researchers measure

Primary outcomes

  1. To investigate the safety and tolerability of SC0191 in combination with gemcitabine or paclitaxel

    ncidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0

    Time frame: From the first dose of study treatment until 30 days after the last dose.

  2. To identify the recommended Phase 2 dose (RP2D) of SC0191 in combination with gemcitabine or paclitaxel

    Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1

    Time frame: Through Cycle 1 (cycle is 28 days）

Secondary outcomes

  1. To investigate the plasma pharmacokinetics (PK) of SC0191 in combination with gemcitabine or paclitaxel

    Plasma pharmacokinetics (PK) of SC0191 in combination with chemotherapy: Single Dose SC0191 Cmax, Tmax, t1/2,AUC0-24h, AUC0-last, CL/F, Vd/F, and steady state SC0191 Ctrough, Cmax,ss, Cavg,ss, Tmax,ss, AUC0-τ, Rac.

    Time frame: Through Cycle 1 (cycle is 28 days）

  2. To obtain estimates of clinical activity by determining the objective response rate (ORR) of SC0191 in combination with gemcitabine or paclitaxel

    Objective response rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1

    Time frame: Through completion

  3. To obtain estimates of clinical activity by determining the time to CA125 progression of SC0191 in combination with gemcitabine or paclitaxel

    Time to CA125 progression according to the Gynecologic Cancer Intergroup (GCIG) criteria

    Time frame: Through completion

  4. To obtain estimates of clinical activity by determining the progression-free survival (PFS) of SC0191 in combination with gemcitabine or paclitaxel

    Progression-free survival (PFS) as defined by RECIST version 1.1 and clinical criteria

    Time frame: Through completion

  5. To obtain estimates of clinical activity by determining the duration of response (DOR) of SC0191 in combination with gemcitabine or paclitaxel

    Duration of response (DOR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1

    Time frame: Through completion

  6. To obtain estimates of clinical activity by determining the disease control rate (DCR) of SC0191 in combination with gemcitabine or paclitaxel

    Disease control rate (DCR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1

    Time frame: Through completion

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06055348
Lead sponsor
Biocity Biopharmaceutics Co., Ltd.
Responsible party
Sponsor
First posted
Sep 26, 2023
Start date
Oct 30, 2023 (estimated)
Primary completion
Aug 30, 2025 (estimated)
Completion
Nov 30, 2025 (estimated)
Last update
Sep 26, 2023

Study contacts

Xiaohua Wu
Contact
wu.xh@fudan.edu.cn
021-64175590 ext. 200000
Jian Zhang
Contact
syner2000@163.com
021-64175590 ext. 200000

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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