Advanced Solid Tumor or Hematologic TumorPhase 1NCT04481607
A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets
A Phase 1 study testing TQB3454 in people with Advanced Solid Tumor or Hematologic Tumor, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites in China.
Trial summary
This is a open-label, multicenter, phase I study to evaluate tolerance and pharmacokinetics of TQB3454 tablets in subjects with advanced solid tumor or hematologic tumor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor or Hematologic Tumor
- What is being tested?
- TQB3454
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 5 sitesChina
- Study dates
- 24 Aug 2020to 31 Dec 2022
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
- 2. Advanced solid tumors or hematological malignancy. 3. Adequate laboratory indicators. 4. No pregnant or breastfeeding women, and a negative pregnancy test. 5. Understood and Signed an informed consent form.
Who cannot join
- 1. Has central nervous system metastasis or system leukemia. 2.Previous anti-tumor treatment:
- Has received IDH1 mutation inhibitor.
- Has received systemic anti-tumor therapy or radiotherapy within 14 days before the first dose.
- Has received oral targeted drugs, less than 5 drug half-lives from first dose.
- The related toxicity of previous anti-tumor therapy has not recovered to CTCAE ≤ grade 2, except for hair loss.
- 3.Complicated disease and medical history:
Show all 31Show fewer
- <!-- -->
- Active hepatitis B or hepatitis C.
- Abnormal kidney.
- Abnormal cardiovascular and cerebrovascular.
- Abnormal gastrointestinal.
- Has medical history of immunodeficiency.
- Has bleeding (hemoptysis), coagulopathy, or been using warfarin, aspirin, and other antiplatelet agglutination drugs.
- Has uncontrollable systemic bacterial, fungal or viral active infections.
- Has medical history of idiopathic pulmonary fibrosis,or tissue pneumonia.
- Has allergic constitution or previous severe allergy; or known allergy to ingredients of study drug.
- Has neurological or mental disorders.
- Has a history of drug abuse or drug addict.
- Has received major surgery, open biopsy, or obvious traumatic injury within 4 weeks before the first dose.
- According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
- 4. Has participated in other clinical trials within 30 days before participating in this trial.
- 5. Female patients during pregnancy or lactation. 6. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
- 7. criteria for solid tumors:
- <!-- -->
- Has any signs of bleeding constitution.
- Has any CTCAE ≥ grade 3 bleeding or bleeding event,within 4 weeks before the first dose.
- Has unhealed wounds, fractures, active ulcers of the stomach and duodenum, ulcerative colitis and other digestive tract diseases.
- Imaging (CT or MRI) shows that the tumor has invaded the circumference of important blood vessels.
- Has uncontrollable pleural effusion, pericardial effusion or ascites that still need repeated drainage.
- criteria for blood tumor:
- Has severe life-threatening leukemia complications.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100089
Lin Shen, Doctor, 010-88196340, doctorshenlin@sina.cn
Lin Shen, Doctor
- Recruiting
The First Affiliated Hosptial Zhejiang University School of Medical
Hangzhou, Zhejiang, 311100
Yi Zheng, Doctor, 0571-87235114, oncologist@zju.edu.cn
Jian Liu, Master, 0571-87235114, lindaliu87@zju.edu.cn
- Recruiting
Tianjing Medical University Cancer Institute&Hospital
Tianjin, Tianjin Municipality, 300020
Yi Ba, Doctor, 022-23909999, bayi@tjmuch.com
Yafei Wang, 022-23909999, Drwang2005@163.com
- Recruiting
Hematology Hospital of Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300041
Jianxiang Wang, Doctor, 022-23909278, wangjx@ihcams.ac.cn
Junyuan Qi, Doctor, 022-23909067, qijy@ihcams.ac.cn
- Recruiting
The Affiliated Hosptial of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Kailin Xu, doctor, 0516-85609999, lihmd@163.com
About this study
Official title: A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets
This is a open-label, multicenter, phase I study to evaluate tolerance and pharmacokinetics of TQB3454 tablets in subjects with advanced solid tumor or hematologic tumor.
- Being tested
- TQB3454
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3454Drug
TQB3454 tablets is a small molecule oral drug.
| Study group | Role | What they receive |
|---|---|---|
| TQB3454 tablets | Experimental | TQB3454 tablets administered orally once. Then TQB3454 tablets administered orally, once daily in 28-day cycle after 7 days of first administration. Receives: Drug: TQB3454 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
Measured: Baseline up to 28 days
Secondary outcomes (6)
Cmax
Cmax is the maximum plasma concentration of TQB3454 or metabolite(s).
Measured: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;
Tmax
To characterize the pharmacokinetics of TQB3454 by assessment of time to reach maximum plasma concentration.
Measured: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;
AUC0-t
To characterize the pharmacokinetics of TQB3454 by assessment of area under the plasma concentration time curve from zero to infinity.
Measured: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;
Objective response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Measured: up to 60 weeks
Progression-free survival (PFS)
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Measured: Up to 60 weeks
2-hydroxyglutaric acid
Correlation between 2-hydroxyglutaric acid and efficacy
Measured: Hour 0(pre-dose) on single dose; Hour 0(pre-dose) of day1, day8, day15, day28 on multiple dose of first cycle; hour 0(pre-dose) of day15, day28 of second and third cycle; hour 0(pre-dose) of day28 of fourth to eighth cycle.Each cycle is 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start24 Aug 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid Tumor or Hematologic TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 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
- NCT04481607
- Sponsor's protocol ID
- TQB3454-I-02
- Status last verified
- Jan 2022
- First submitted
- 19 Jul 2020
- Last updated
- 10 Jan 2022
- 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 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3454 Tablets
- ClinicalTrials.gov ID
- NCT04481607
- Acronym / sponsor ID
- TQB3454-I-02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 22 Jul 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 open-label, multicenter, phase I study to evaluate tolerance and pharmacokinetics of TQB3454 tablets in subjects with advanced solid tumor or hematologic tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3454 tablets | Experimental | Drug: TQB3454TQB3454 tablets administered orally once. Then TQB3454 tablets administered orally, once daily in 28-day cycle after 7 days of first administration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1; Life expectancy ≥12 weeks.
- 2. Advanced solid tumors or hematological malignancy. 3. Adequate laboratory indicators. 4. No pregnant or breastfeeding women, and a negative pregnancy test. 5. Understood and Signed an informed consent form.
Key exclusion criteria (31 listed)
- 1. Has central nervous system metastasis or system leukemia. 2.Previous anti-tumor treatment:
- <!-- -->
- 4. Has participated in other clinical trials within 30 days before participating in this trial.
- 5. Female patients during pregnancy or lactation. 6. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
- <!-- -->
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 |
|---|---|---|
| TQB3454TQB3454 tablets is a small molecule oral drug. | Drug | TQB3454 tablets |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Baseline up to 28 days
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
6 secondary outcomes
Cmax
Time frame: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;
Tmax
Time frame: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;
AUC0-t
Time frame: Hour 0(pre-dose), 0.5, 1, 2, 3, 5, 8, 10, 24, 48, 72, 120, 168 hours post-dose on single dose;
Objective response rate (ORR)
Time frame: up to 60 weeks
Progression-free survival (PFS)
Time frame: Up to 60 weeks
2-hydroxyglutaric acid
Time frame: Hour 0(pre-dose) on single dose; Hour 0(pre-dose) of day1, day8, day15, day28 on multiple dose of first cycle; hour 0(pre-dose) of day15, day28 of second and third cycle; hour 0(pre-dose) of day28 of fourth to eighth cycle.Each cycle is 28 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
Related trials for Advanced Solid Tumor or Hematologic Tumor
RecruitingPhase 3
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
Solid Tumors, Hematologic Malignancies
Active, not recruitingPhase 2
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing GDC-0449 (Vismodegib) as Potentially Targeted Treatment in Cancers With Smoothened or Patched 1 Mutant Tumors (MATCH - Subprotocol T)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing BVD-523FB (Ulixertinib) as Potentially Targeted Treatment in Cancers With Genetic Changes (MATCH - Subprotocol Z1L)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1/2
Durvalumab and Tremelimumab for Pediatric Malignancies
Pediatric Cancer, Solid Tumor Pediatric
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 study testing TQB3454 in people with Advanced Solid Tumor or Hematologic Tumor, 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 2 inclusion and 31 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 10 Jan 2022. 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 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.
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 Lin Shen, Doctor (010-88196340, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: Baseline up to 28 days). 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 10 Jan 2022.