Advanced Solid TumordPhase 1/2NCT04001075
Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese Patients With Advanced Solid Tumors
A Phase 1/2 study testing TJ107 in people with Advanced Solid Tumord, run by TJ Biopharma Co., Ltd. at 4 sites in China.
Trial summary
This is a two-part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of TJ107 in Chinese patients with advanced solid tumors. Approximately a total of 36 ~ 60 patients will be enrolled into the dose escalation cohorts (Part A), and expansion cohorts (Part B). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumord
- What is being tested?
- TJ107
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 4 sitesChina
- Study dates
- 25 Feb 2019to 23 Sep 2021
- 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
- Aged at least 18 years old;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~2;
- Patients must have histological or cytological confirmation of advanced solid tumors that is refractory to standard therapy or for which there is no standard available therapy;
- Predicted life expectancy ≥3 months;
- Patients must have adequate organ and marrow function;
- Patients at reproductive age should take adequate contraceptive measures while on study drug and for 6 months following the last dose of study drug.
- Patients should have the ability and willingness to comply with the study and follow up. And patients must be able to provide written informed consent.
Who cannot join
- Patients who have experienced a Grade 3 or higher toxicity related to prior immunotherapy.
- Patients who are still receive anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or other clinical trials from 4 weeks prior to the first dose, or patients who have not recovered from previous toxicity to level 1.
- Women who are pregnant or breast feeding
- Patients who are drug-dependent or have a history of substance abuse or psychonosema history.
- Have been vaccinated within 4 weeks of study dosing, with the exception of licensed intranasal or intramuscular influenza vaccine during study
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation
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- Positive laboratory test for HBsAg with HBV DNA ≥ 100 IU/mL, or positive laboratory test for HCV.
- Prior treatment with immune checkpoint inhibitors, immunomodulatory mAbs, and/or mAb-derived therapies is allowed provided that at least 3 months or 5 half-lives of the drug, whichever is longer, have elapsed from the last dose.
- Uncontrolled concurrent illness.
- Major surgery procedure (excluding diagnostic surgery) within 4 weeks of the first dose of study drug.
- Patients with a history of treated CNS metastases.
- Other psychiatric illness/social situations that would limit compliance with the study requirements decided by the investigator.
Trial locations and contacts
4 sites in 1 country.
China4 sites
The sixth Affiliated Hospital, Sun Yat-sen University
Guanzhou, Guangdong, 510655
Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of the Medical
Hangzhou, Zhejiang, 310016
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
the First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: A Phase I/IIa, Open-label, Dose-Escalation and Dose Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese Patients With Advanced Solid Tumors
This is a two-part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of TJ107 in Chinese patients with advanced solid tumors. Approximately a total of 36 ~ 60 patients will be enrolled into the dose escalation cohorts (Part A), and expansion cohorts (Part B).
- Conditions
- Advanced Solid Tumord
- Being tested
- TJ107
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ107Drug
Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period
| Study group | Role | What they receive |
|---|---|---|
| TJ107 | Experimental | Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period Receives: Drug: TJ107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities
Safety and tolerability of TJ107. Incidence of dose-limiting toxicities (DLTs)
Measured: 28days after first dose
Adverse events
Safety and tolerability of TJ107. Incidence of adverse events
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Serious adverse events
Safety and tolerability of TJ107. Incidence of serious adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events(CI CTCAE 5.0)
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Maximum tolerated dose
Maximum tolerated dose (MTD)
Measured: through study completion, an average of 1 year
Maximum effective dose
Maximum effective dose (MED)
Measured: through study completion, an average of 1 year
Recommended phase II dose
Recommended phase II dose (RP2D)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start25 Feb 2019
- Primary completion30 Jun 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumordStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- TJ Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001075
- Sponsor's protocol ID
- TJ107001STM101
- Status last verified
- Apr 2024
- First submitted
- 23 Jun 2019
- Last updated
- 15 Apr 2024
- 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 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Open-label, Dose-Escalation and Dose Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04001075
- Acronym / sponsor ID
- TJ107001STM101
- Conditions
- Advanced Solid Tumord
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- TJ Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 27 Jun 2019 (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 two-part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of TJ107 in Chinese patients with advanced solid tumors. Approximately a total of 36 ~ 60 patients will be enrolled into the dose escalation cohorts (Part A), and expansion cohorts (Part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TJ107 | Experimental | Drug: TJ107Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged at least 18 years old;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~2;
- Patients must have histological or cytological confirmation of advanced solid tumors that is refractory to standard therapy or for which there is no standard available therapy;
- Predicted life expectancy ≥3 months;
- Patients must have adequate organ and marrow function;
Key exclusion criteria (12 listed)
- Patients who have experienced a Grade 3 or higher toxicity related to prior immunotherapy.
- Patients who are still receive anti-tumor therapy such as radiotherapy, chemotherapy, targeted therapy, endocrine therapy, or other clinical trials from 4 weeks prior to the first dose, or patients who have not recovered from previous toxicity to level 1.
- Women who are pregnant or breast feeding
- Patients who are drug-dependent or have a history of substance abuse or psychonosema history.
- Have been vaccinated within 4 weeks of study dosing, with the exception of licensed intranasal or intramuscular influenza vaccine during 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 |
|---|---|---|
| TJ107Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period | Drug | TJ107 |
Primary outcome
Dose Limiting Toxicities
Time frame: 28days after first dose
Safety and tolerability of TJ107. Incidence of dose-limiting toxicities (DLTs)
Adverse events
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Safety and tolerability of TJ107. Incidence of adverse events
Serious adverse events
Time frame: through study completion, an average of 1 year
Safety and tolerability of TJ107. Incidence of serious adverse events by National Cancer Institute Common Terminology Criteria for Adverse Events(CI CTCAE 5.0)
3 secondary outcomes
Maximum tolerated dose
Time frame: through study completion, an average of 1 year
Maximum effective dose
Time frame: through study completion, an average of 1 year
Recommended phase II dose
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
4 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 TJ107 in people with Advanced Solid Tumord, run by TJ Biopharma Co., Ltd. at 4 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 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: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (time frame: 28days after first dose). The study lists 3 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 15 Apr 2024.