Serous Ovarian CancerPhase 1/2NCT06055348
SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer
A Phase 1/2 study testing SC0191, Gemcitabine and Paclitaxel in people with Serous Ovarian Cancer and Advanced Ovarian Cancer, run by Biocity Biopharmaceutics Co., Ltd..
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Serous Ovarian Cancer, Advanced Ovarian Cancer
- What is being tested?
- SC0191, Gemcitabine and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2023to 30 Nov 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
- 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);
- There is at least one measurable lesion that meets the definition of RECIST 1.1;
- Voluntarily participate in clinical trials and sign informed consent;
- Age ≥18 years;
- ECOG score of 0 to 1;
Show all 9Show fewer
- Predicted life expectancy ≥3 months;
- Adequate bone marrow, liver biochemistry, renal function, and coagulation status.
- Female patients who agree to use adequate contraceptive measures.
Who cannot join
- Received chemotherapy, radiotherapy, immunotherapy or biological therapy, steroid therapy or other investigational drugs <28 days prior to the first dose of study treatment.
- Patients who have not fully recovered from surgery according to the investigator's judgment.;
- Patients who have previously received WEE1 inhibitor treatment;
- Unresolved AEs or toxicities due to previous treatments;
- Patients with contraindications or a history of severe allergies to gemcitabine or paclitaxel;
- Known malignant CNS disease other than neurologically stable, treated brain metastases;
Show all 10Show fewer
- Other medical conditions or systemic diseases not suitable to participate;
- The need for long-term therapeutic doses of anticoagulant or antiplatelet drugs;
- Received CYP3A4 moderate or strong inhibitors or CYP3A4 moderate or strong inducers within 14 days;
- Pregnant or lactating women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase Ib/II Clinical Study on the Safety, Pharmacokinetic Characteristics, and Preliminary Efficacy of SC0191 Combination Chemotherapy in Patients With Advanced Ovarian Cancer.
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.
- Conditions
- Serous Ovarian Cancer, Advanced Ovarian Cancer
- Being tested
- SC0191, Gemcitabine, Paclitaxel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC0191Drug
Also called Study drug
SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle.
GemcitabineDrug
Also called Gemcitabine Injection
Gemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.
PaclitaxelDrug
Also called Taxol
Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Arm A (SC0191 + Gemcitabine). | Experimental | 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. Receives: Drug: SC0191; Drug: Gemcitabine |
| Arm B (SC0191 + Paclitaxel). | Experimental | 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. Receives: Drug: SC0191; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the first dose of study treatment until 30 days after the last dose.
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
Measured: Through Cycle 1 (cycle is 28 days）
Secondary outcomes (6)
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.
Measured: Through Cycle 1 (cycle is 28 days）
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
Measured: Through completion
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
Measured: Through completion
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
Measured: Through completion
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
Measured: Through completion
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
Measured: Through completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study start30 Oct 2023 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serous Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocity Biopharmaceutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055348
- Sponsor's protocol ID
- SC0191-102
- Status last verified
- Sep 2023
- First submitted
- 15 Aug 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Study on the Safety, Pharmacokinetic Characteristics, and Preliminary Efficacy of SC0191 Combination Chemotherapy in Patients With Advanced Ovarian Cancer.
- ClinicalTrials.gov ID
- NCT06055348
- Acronym / sponsor ID
- SC0191-102
- Conditions
- Serous Ovarian Cancer, Advanced Ovarian Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Biocity Biopharmaceutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Oct 2023 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase Ib/II clinical study on the safety, pharmacokinetic characteristics, and preliminary efficacy of SC0191 combination chemotherapy in patients with advanced ovarian cancer.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (SC0191 + Gemcitabine). | Experimental | Drug: SC0191, Drug: GemcitabineSC0191 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. |
| Arm B (SC0191 + Paclitaxel). | Experimental | Drug: SC0191, Drug: PaclitaxelSC0191 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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);
- 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);
- There is at least one measurable lesion that meets the definition of RECIST 1.1;
- Voluntarily participate in clinical trials and sign informed consent;
- Age ≥18 years;
Key exclusion criteria (10 listed)
- Received chemotherapy, radiotherapy, immunotherapy or biological therapy, steroid therapy or other investigational drugs <28 days prior to the first dose of study treatment.
- Patients who have not fully recovered from surgery according to the investigator's judgment.;
- Patients who have previously received WEE1 inhibitor treatment;
- Unresolved AEs or toxicities due to previous treatments;
- Patients with contraindications or a history of severe allergies to gemcitabine or paclitaxel;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC0191Also: Study drugSC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle. | Drug | Arm A (SC0191 + Gemcitabine)., Arm B (SC0191 + Paclitaxel). |
| GemcitabineAlso: Gemcitabine InjectionGemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle. | Drug | Arm A (SC0191 + Gemcitabine). |
| PaclitaxelAlso: TaxolPaclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle. | Drug | Arm B (SC0191 + Paclitaxel). |
Primary outcome
To investigate the safety and tolerability of SC0191 in combination with gemcitabine or paclitaxel
Time frame: From the first dose of study treatment until 30 days after the last dose.
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
To identify the recommended Phase 2 dose (RP2D) of SC0191 in combination with gemcitabine or paclitaxel
Time frame: Through Cycle 1 (cycle is 28 days）
Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1
6 secondary outcomes
To investigate the plasma pharmacokinetics (PK) of SC0191 in combination with gemcitabine or paclitaxel
Time frame: Through Cycle 1 (cycle is 28 days）
To obtain estimates of clinical activity by determining the objective response rate (ORR) of SC0191 in combination with gemcitabine or paclitaxel
Time frame: Through completion
To obtain estimates of clinical activity by determining the time to CA125 progression of SC0191 in combination with gemcitabine or paclitaxel
Time frame: Through completion
To obtain estimates of clinical activity by determining the progression-free survival (PFS) of SC0191 in combination with gemcitabine or paclitaxel
Time frame: Through completion
To obtain estimates of clinical activity by determining the duration of response (DOR) of SC0191 in combination with gemcitabine or paclitaxel
Time frame: Through completion
To obtain estimates of clinical activity by determining the disease control rate (DCR) of SC0191 in combination with gemcitabine or paclitaxel
Time frame: Through completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
Related trials for Serous Ovarian Cancer
Recruiting
Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
High Grade Serous Ovarian Cancer
Not yet recruitingPhase 2
Study of Suvemcitug Plus Chemotherapy in Advanced High-Grade Serous Ovarian Cancer
High-grade Serous Ovarian Cancer
RecruitingPhase 2
Sacituzumab Govitecan With Bevacizumab Compared to Usual Chemotherapy (Carboplatin, Pegylated Liposomal Doxorubicin and Bevacizumab) for Treating Recurrent Platinum-Sensitive Ovarian Cancer After PARP Inhibitor Maintenance Therapy
Recurrent Platinum-Sensitive Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Platinum-Sensitive Fallopian Tube High Grade Serous Adenocarcinoma
RecruitingPhase 2
Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer
Ovarian Cancer
RecruitingPhase 1
Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
Recurrent Ovarian High Grade Serous Adenocarcinoma, Recurrent Platinum-Resistant Ovarian Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SC0191, Gemcitabine and Paclitaxel in people with Serous Ovarian Cancer and Advanced Ovarian Cancer, run by Biocity Biopharmaceutics Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaohua Wu (021-64175590 ext. 200000, wu.xh@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the safety and tolerability of SC0191 in combination with gemcitabine or paclitaxel (time frame: From the first dose of study treatment until 30 days after the last dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.