Gynecological CancerPhase 1/2NCT04236362
A Study of TQB2450 Combined With Anlotinib in Subjects With Gynecological Cancer
A Phase 1/2 study testing TQB2450 and Anlotinib in people with Gynecological Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites in China.
Trial summary
This is a single-arm, open-label, phase Ib clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib in subjects with gynecological cancer, including 34 ovarian cancer，34 endometrial cancer，22 cervical cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gynecological Cancer
- What is being tested?
- TQB2450 and Anlotinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesChina
- Study dates
- 27 Feb 2020to 30 May 2022
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understood and signed an informed consent form;
- 18 years and older, male or female, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, life expectancy ≥ 3 months;
- Histologically confirmed, unresectable recurrent/metastatic advanced gynecologic cancer, including ovarian, endometrial, and cervical cancer;
- Subjects have received at least 1 line platinum-containing chemotherapy (minimum of 4 cycles of platinum-containing treatment) after tumor reduction, and meet any of the following：Platinum-resistant or refractory patients, including patients who have progressed or relapsed during previous platinum-containing chemotherapy regimens or within 6 months after the end of platinum-containing chemotherapy;
- At least one measurable lesion according to the RECIST 1.1;
- The main organs function are normally;
- Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
Who cannot join
- Has other non-epithelial ovarian tumors or borderline ovarian epithelial tumors;
- Other malignant tumors that have appeared or are currently present within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors;
- Has previously received immune drugs such as PD-1 / PD-L1, CTLA-4 or other tyrosine kinase inhibitors such as anlotinib hydrochloride;
- Has received bevacizumab within 28 days before the first dose;
- Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks;
- Expect to use any active vaccine against infectious diseases (such as influenza vaccine, chickenpox vaccine, etc.) within 28 days before the first dose or during the study period;
Show all 16Show fewer
- Patients diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose> 10mg / day prednisone or other effective hormones) and continue to use it within 2 weeks before the first dose;
- Active autoimmune diseases that require systemic treatment have occurred within 2 years before the first dose;
- Subjects known to be allergic to the study drug or any of its excipients or have experienced a severe allergic reaction to other monoclonal antibodies;
- Has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous meningitis;
- Has any bleeding or bleeding event ≥ CTC AE Grade 3 or unhealed wounds, ulcers or fractures within 4 weeks before the first dose;
- Has clinically significant thyroid dysfunction before the first dose;
- Has multiple factors affecting oral medication;
- Has any severe acute complications before the first dose;
- Has participated in other anti-tumor intervention clinical trials within 4 weeks before the first medication;
- According to the judgement of the researchers, there are other factors that may lead to the termination of the study. For example, other serious diseases including mental disorders need to be treated together, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data and samples.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality, 100039
Shunchang Jiao, 13801380677, jiaosc@vip.sina.com
Shunchang Jiao
- Recruiting
Cancer Hospital of Chongqing University
Chongqing, Chongqing Municipality, 400030
Qi Zhou, 13708384529, qizhou9128@163.com
Qi Zhou
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510000
Xin Huang, 020-87343014, huangxin@sysucc.org.cn
Xin Huang
- Recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Liu Chang, 44025660@qq.com
Liu Chang
- Recruiting
First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000
Jin Haihong, jhh660625@sina.com
Jin Haihong
About this study
Official title: A Phase Ib, Single Arm, Open-label Study of TQB2450 Combined With Anlotinib in Subjects With Relapsed / Refractory Gynecological Cancer
This is a single-arm, open-label, phase Ib clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib in subjects with gynecological cancer, including 34 ovarian cancer，34 endometrial cancer，22 cervical cancer.
- Conditions
- Gynecological Cancer
- Being tested
- TQB2450, Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2450Drug
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
AnlotinibDrug
A multi-target receptor tyrosine kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| TQB2450+Anlotinib | Experimental | TQB2450 1200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) Receives: Drug: TQB2450; Drug: Anlotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)
Measured: up to 96 weeks
Secondary outcomes (4)
Progression free survival (PFS)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Measured: up to 96 weeks
Duration of Response (DOR)
Time from tumor first assessment to CR or PR to first assessment to PD (Progressive Disease) or death from any cause
Measured: up to 96 weeks
Disease control rate（DCR）
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Measured: up to 96 weeks
Overall Survival (OS)
OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Measured: up to 120 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start27 Feb 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecological CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236362
- Sponsor's protocol ID
- TQB2450-Ib-10
- Status last verified
- Jan 2021
- First submitted
- 18 Jan 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lan CY, Zhao J, Yang F, Xiong Y, Li R, Huang Y, Wang J, Liu C, Bi XH, Jin HH, Meng J, Zhao WH, Zhang L, Wang YF, Zheng M, Huang X. Anlotinib combined with TQB2450 in patients with platinum-resistant or -refractory ovarian cancer: A multi-center, single-arm, phase 1b trial. Cell Rep Med. 2022 Jul 19;3(7):100689. doi: 10.1016/j.xcrm.2022.100689.
PubMed 35858589
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Single Arm, Open-label Study of TQB2450 Combined With Anlotinib in Subjects With Relapsed / Refractory Gynecological Cancer
- ClinicalTrials.gov ID
- NCT04236362
- Acronym / sponsor ID
- TQB2450-Ib-10
- Conditions
- Gynecological Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 22 Jan 2020 (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.
This is a single-arm, open-label, phase Ib clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib in subjects with gynecological cancer, including 34 ovarian cancer，34 endometrial cancer，22 cervical cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB2450+Anlotinib | Experimental | Drug: TQB2450, Drug: AnlotinibTQB2450 1200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Understood and signed an informed consent form;
- 18 years and older, male or female, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, life expectancy ≥ 3 months;
- Histologically confirmed, unresectable recurrent/metastatic advanced gynecologic cancer, including ovarian, endometrial, and cervical cancer;
- Subjects have received at least 1 line platinum-containing chemotherapy (minimum of 4 cycles of platinum-containing treatment) after tumor reduction, and meet any of the following：Platinum-resistant or refractory patients, including patients who have progressed or relapsed during previous platinum-containing chemotherapy regimens or within 6 months after the end of platinum-containing chemotherapy;
- At least one measurable lesion according to the RECIST 1.1;
Key exclusion criteria (16 listed)
- Has other non-epithelial ovarian tumors or borderline ovarian epithelial tumors;
- Other malignant tumors that have appeared or are currently present within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors;
- Has previously received immune drugs such as PD-1 / PD-L1, CTLA-4 or other tyrosine kinase inhibitors such as anlotinib hydrochloride;
- Has received bevacizumab within 28 days before the first dose;
- Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks;
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 |
|---|---|---|
| TQB2450TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. | Drug | TQB2450+Anlotinib |
| AnlotinibA multi-target receptor tyrosine kinase inhibitor | Drug | TQB2450+Anlotinib |
Primary outcome
Objective Response Rate (ORR)
Time frame: up to 96 weeks
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)
4 secondary outcomes
Progression free survival (PFS)
Time frame: up to 96 weeks
Duration of Response (DOR)
Time frame: up to 96 weeks
Disease control rate（DCR）
Time frame: up to 96 weeks
Overall Survival (OS)
Time frame: up to 120 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2021.
- Derived from this study: PubMed 35858589Lan CY, Zhao J, Yang F, Xiong Y, Li R, Huang Y, Wang J, Liu C, Bi XH, Jin HH, Meng J, Zhao WH, Zhang L, Wang YF, Zheng M, Huang X. Anlotinib combined with TQB2450 in patients with platinum-resistant or -refractory ovarian cancer: A multi-center, single-arm, phase 1b trial. Cell Rep Med. 2022 Jul 19;3(7):100689. doi: 10.1016/j.xcrm.2022.100689.
Related trials for Gynecological Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 2
A Three-arm Randomized Phase II Study of Dostarlimab Alone or With Bevacizumab Versus Nonplatinum Chemotherapy in Recurrent Gynecological Clear Cell Carcinoma: DOVE (APGOT-OV7/ ENGOT-ov80 Study)
Ovarian Neoplasms, Endometrial Neoplasms
RecruitingPhase 1/2
A Study of Mocertatug Rezetecan in Combination With Anti-cancer Therapies for Advanced Solid Tumors (BEHOLD-2)
Tumours, Gynecological
Active, not recruitingObservational study
Diet, Hepcidin, and Chemotherapy RDI
Breast Cancer Female, Ovarian Cancer
RecruitingObservational study
GYNGHER - HER2 Expression in Gynecological Malignancies: a Brazilian Cohort
Gynaecological Cancers
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQB2450 and Anlotinib in people with Gynecological Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites in China.
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 7 inclusion and 16 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 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Xin Huang (020-87343014, huangxin@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: up to 96 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236362, which also lists 1 linked publication.
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 12 Jan 2021.