MSI-H or dMMR Advanced Solid TumorsPhase 2NCT04291248
A Study of Anlotinib Combined With AK105 Injection in Subjects With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Advanced Solid Tumor
A Phase 2 study testing AK105 and Anlotinib in people with MSI-H or dMMR Advanced Solid Tumors, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 sites in China.
Trial summary
This study is designed to evaluate the efficacy and safety of Anlotinib combined with AK105 injection or AK105 monotherapy in subjects with MSI-H or dMMR advanced solid tumors. In this study, 138 subjects will be enrolled, and those who met the admission criteria will divide into cohort 1 (anlotinib combined with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MSI-H or dMMR Advanced Solid Tumors
- What is being tested?
- AK105 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
- 138 participants
- Where
- 9 sitesChina
- Study dates
- Mar 2020to Dec 2022
- Phase
- Phase 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
- 1. Histopathologically confirmed MSI-H or dMMR advanced malignant solid tumors. 2. Has provided previously achieved tumor tissue samples or fresh samples. 3. 18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
- 4. At least one measurable lesion. 5. The main organs function are normally. 6.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.
- 7.Understood and signed an informed consent form.
Who cannot join
- 1.Has used against PD-1, PD-L1 and other related immunotherapeutic drugs. 2. Has received chemotherapy, radiotherapy or other treatments within 4 weeks prior to the first dose.
- 3. Has brain metastases with symptoms or symptoms control for less than 2 months.
- 4. Has diagnosed and/or treated additional malignancy within 3 years prior to the first dose.
- 5. Has multiple factors affecting oral medication. 6.Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- 7. Has unrelieved spinal cord compression. 8. Imaging shows that tumors invade large blood vessels. 9. Has hemoptysis within 1 month prior to the first dose and maximum daily hemoptysis ≥2.5 mL.
- 10. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.
Show all 12Show fewer
- 11. Has received surgery, or unhealed wounds within 4 weeks before the first dose.
- 12. Has artery/venous thrombosis prior to the first dose within 6 months. 13. Has drug abuse history that unable to abstain from or mental disorders. 14. Has any serious and / or uncontrolled disease. 15. Has received vaccination or attenuated vaccine within 4 weeks prior to the first dose.
- 16. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal or its components.
- 17. Has active autoimmune diseases requiring systemic treatment occurred within 2 years before the first administration.
- 18.Immunosuppressive therapy with immunosuppressive agents or systemic or absorbable local hormones (dosage > 10 mg/day prednisone or other therapeutic hormones) is required for the purpose of immunosuppression, and is still in use for 2 weeks after the first dose.
- 19. Has a history of active TB. 20. Has participated in other anticancer drug clinical trials within 4 weeks. 20. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Hospital
Beijing, Beijing Municipality, 100010
Yunbo Zhao, Doctor, 010-85136715, zhaoyb1206@163.com
Yunbo Zhao, Doctor
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Aiping Zhou, Doctor, 010-87788800, zhouap1825@126.com
Aiping Zhou, Doctor
Chinese Academy of Medical Sciences, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Jianfeng Zhou, Doctor, 010-69158750, 13910113193@qq.com
Jianfeng Zhou, Doctor
Peking University International Hospital
Beijing, Beijing Municipality, 102206
Jun Liang, Doctor, liangjun1959@aliyun.com
Jun Liang, Doctor
The Third Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150030
Yanqiao Zhang, Doctor, 0451-86298278, yanqiaozhang@126.com
Yanqiao Zhang, Doctor
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000
Jifeng Feng, Doctor, 025-83283415, fjf@vip.sina.com
Jifeng Feng, Doctor
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Ting Deng, Doctor, 022-23340123, xymcdengting@126.com
Ting Deng, Doctor
The Second Affiliated Hospital of The PLA Air Force Medical University
Xi’an, Shanxi, 710000
Haichuan Su, Doctor, 029-84777455, suhc@fmmu.edu.cn
Haichuan Su, Doctor
Shanxi Cancer Hospital
Xi’an, Shanxi, 710061
Zijun Liao, Doctor, 029-85276142, liaozijun66@sina.com
Zijun Liao, Doctor
About this study
Official title: A Randomized, Open-label , Multi-cohort, Multicenter, Phase II Study of Anlotinib Combined With AK105 Injection in Subjects With MSI-H or dMMR Advanced Solid Tumor
This study is designed to evaluate the efficacy and safety of Anlotinib combined with AK105 injection or AK105 monotherapy in subjects with MSI-H or dMMR advanced solid tumors. In this study, 138 subjects will be enrolled, and those who met the admission criteria will divide into cohort 1 (anlotinib combined with AK105) and cohort 2 (AK105 ). The first phase of this study is a randomized, open-label, parallel-controlled, multicenter design, in which 30 subjects are randomly enrolled in two cohorts. The second phase is to continue enrollment of cohort 1 or cohort 2 when which cohort has the better clinical benefit than the other one.
- Conditions
- MSI-H or dMMR Advanced Solid Tumors
- Being tested
- AK105, Anlotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK105Drug
AK105 is a humanized monoclonal antibody that specifically binds to PD-1. AK105 has a typical antibody structure and is composed of two lgG1 subtype heavy chains and two kappa subtypes light chains covalently linked by disulfide bonds.
AnlotinibDrug
A multi-target receptor tyrosine kinase inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib+AK105 injection | Experimental | AK105 200mg intravenously (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: AK105; Drug: Anlotinib |
| AK105 injection | Experimental | AK105 200mg intravenously (IV) on day 1 of each 21-day cycle. Receives: Drug: AK105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR) assessed by Independent Review Committee (IRC)
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
Measured: up to 96 weeks
Secondary outcomes (5)
Overall response rate (ORR) assessed by investigator
Percentage of subjects achieving complete response (CR) and partial response (PR) based on investigator.
Measured: up to 96 weeks
Disease control rate（DCR）
Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
Measured: up to 96 weeks
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Measured: up to 96 weeks
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
Overall survival (OS)
OS defined as the time from the first dose to death from any cause. Subjects 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 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MSI-H or dMMR Advanced Solid TumorsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 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
- NCT04291248
- Sponsor's protocol ID
- ALTN-AK105-II-03
- Status last verified
- Dec 2019
- First submitted
- 28 Feb 2020
- Last updated
- 2 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label , Multi-cohort, Multicenter, Phase II Study of Anlotinib Combined With AK105 Injection in Subjects With MSI-H or dMMR Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT04291248
- Acronym / sponsor ID
- ALTN-AK105-II-03
- Conditions
- MSI-H or dMMR Advanced Solid Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 2 Mar 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 study is designed to evaluate the efficacy and safety of Anlotinib combined with AK105 injection or AK105 monotherapy in subjects with MSI-H or dMMR advanced solid tumors. In this study, 138 subjects will be enrolled, and those who met the admission criteria will divide into cohort 1 (anlotinib combined with AK105) and cohort 2 (AK105 ). The first phase of this study is a randomized, open-label, parallel-controlled, multicenter design, in which 30 subjects are randomly enrolled in two cohorts. The second phase is to continue enrollment of cohort 1 or cohort 2 when which cohort has the better clinical benefit than the other one.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anlotinib+AK105 injection | Experimental | Drug: AK105, Drug: AnlotinibAK105 200mg intravenously (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). |
| AK105 injection | Experimental | Drug: AK105AK105 200mg intravenously (IV) on day 1 of each 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Histopathologically confirmed MSI-H or dMMR advanced malignant solid tumors. 2. Has provided previously achieved tumor tissue samples or fresh samples. 3. 18 years and older; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.
- 4. At least one measurable lesion. 5. The main organs function are normally. 6.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.
- 7.Understood and signed an informed consent form.
Key exclusion criteria (12 listed)
- 1.Has used against PD-1, PD-L1 and other related immunotherapeutic drugs. 2. Has received chemotherapy, radiotherapy or other treatments within 4 weeks prior to the first dose.
- 3. Has brain metastases with symptoms or symptoms control for less than 2 months.
- 4. Has diagnosed and/or treated additional malignancy within 3 years prior to the first dose.
- 5. Has multiple factors affecting oral medication. 6.Has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- 7. Has unrelieved spinal cord compression. 8. Imaging shows that tumors invade large blood vessels. 9. Has hemoptysis within 1 month prior to the first dose and maximum daily hemoptysis ≥2.5 mL.
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 |
|---|---|---|
| AK105AK105 is a humanized monoclonal antibody that specifically binds to PD-1. AK105 has a typical antibody structure and is composed of two lgG1 subtype heavy chains and two kappa subtypes light chains covalently linked by disulfide bonds. | Drug | AK105 injection, Anlotinib+AK105 injection |
| AnlotinibA multi-target receptor tyrosine kinase inhibitor. | Drug | Anlotinib+AK105 injection |
Primary outcome
Overall response rate (ORR) assessed by Independent Review Committee (IRC)
Time frame: up to 96 weeks
Percentage of subjects achieving complete response (CR) and partial response (PR) based on IRC.
5 secondary outcomes
Overall response rate (ORR) assessed by investigator
Time frame: up to 96 weeks
Disease control rate（DCR）
Time frame: up to 96 weeks
Duration of Response (DOR)
Time frame: up to 96 weeks
Progression-free survival (PFS)
Time frame: up to 96 weeks
Overall survival (OS)
Time frame: up to 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
Related trials for MSI-H or dMMR Advanced Solid Tumors
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors
Advanced Solid Tumors, MSI-H or dMMR Advanced Solid Tumors
RecruitingPhase 2
Tislelizumab (Anti-Programmed Cell Death Protein-1 (PD-1) Antibody) in MSI-H or dMMR Solid Tumors
MSI-H/dMMR Solid Tumors
Active, not recruitingPhase 1
Study of HRO761 Alone or in Combination in Cancer Patients With Specific DNA Alterations Called Microsatellite Instability or Mismatch Repair Deficiency.
MSIhi or dMMR Advanced Unresectable or Metastatic Solid Tumors, Including Colorectal Cancers
RecruitingPhase 1
AMG 436 as Monotherapy and Combination Therapy in Participants With MSI-H/dMMR Solid Tumors
Metastatic or Locally Advanced Solid Tumors With Microsatellite Instability-high (MSI-H) or Mismatched Repair Deficiency (dMMR)
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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK105 and Anlotinib in people with MSI-H or dMMR Advanced Solid Tumors, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 9 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 3 inclusion and 12 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 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 phase mean?
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 Aiping Zhou, Doctor (010-87788800, zhouap1825@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) assessed by Independent Review Committee (IRC) (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?
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 2 Mar 2020.