First-line Non-small-cell Lung CancerPhase 2NCT05338580
Clinical Trial of TJ271 Injection Combined With Pembrolizumab in the Treatment of Advanced Solid Tumors
A Phase 2 study testing TJ271 Injection in Combination with Pembrolizumab in people with First-line Non-small-cell Lung Cancer and First-line Urothelial Carcinoma, run by TJ Biopharma Co., Ltd. at 1 site in China.
Trial summary
A Multi-center, Open-label Phase II Clinical Trial of TJ271 Injection in Combination with Pembrolizumab in Chinese Patients with Advanced Solid Tumors to evaluate the anti-tumor efficacy, safety, pharmacokinetics and immunogenicity of TJ271 in combination with pembrolizumab in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- First-line Non-small-cell Lung Cancer, First-line Urothelial Carcinoma, Second-line Urothelial Carcinoma
- What is being tested?
- TJ271 Injection in Combination with Pembrolizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2023to 31 Dec 2023
- 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
- Volunteer to participate in the clinical study; fully understand and sign the written ICF; willing to follow and able to complete all trial procedures.
- Males or females aged => 18 years (inclusive) at the time of signing informed consent.
- With histologically or cytologically confirmed diagnosis of NSCLC, urothelial carcinoma, or melanoma;
- Subjects have at least 1 measurable lesion as defined by RECIST 1.1 (not reside in a field that has been subjected to prior radiotherapy; if within the radiotherapy field, clear evidence of radiographic progression since 14 days after the completion of prior radiotherapy and prior to study enrollment).
- Provide at least 5 unstained tissue sections; with tumor expression levels of PD-L1, CD73, and B7-H3 (central laboratory test) assessed by IHC; the enrollment of NSCLC cohort can be based on the PD-L1 TPS detection level tested by the local laboratory (see 10.5.1.2 Tumor Tissue Sample-Related Biomarkers for details).
- Expected survival => 3 months.
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- Main organ function is adequate. See details in the protocol Inclusion Criterion.
- Female subjects of childbearing potential must have a negative urine pregnancy test or serum pregnancy test within 72 hours prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Male subjects with reproductive potential and female subjects with pregnancy potential (which refer to men or women who have not been surgically sterilized, and women who are not post-menopausal) must use highly effective contraceptive methods such as oral contraceptives, intrauterine devices, sexual abstinence or barrier contraception in conjunction with spermicides during the course of the study and until 6 months after the last dose.
Who cannot join
- Diseases amenable to a local curative treatment approach.
- Exclusion criteria for each cohort on prior systemic therapy
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137, B7H3). (Melanoma indications is somewhat special, see inclusion criteria 3.4; if patients received prior CTLA- and discontinued due an irAE, this would be excluded).
- Pregnant or lactating women, or expected to become pregnant or give birth to a child during the study.
- Have received systemic anti-tumor therapy including investigational agents within 4 weeks prior to the start of the study treatment or within five half-lives of the study drug, whichever is shorter.
- requiring treatment or hormone replacement may be eligible.
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- History of other malignancies within 5 years prior to signing the ICF or other concurrent active malignancies at screening. Patients with localized tumors that have been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, or cervical carcinoma-in- situ, etc., could be enrolled.
- Has had an allogeneic tissue/solid organ transplant.
- Active autoimmune disease requiring systemic therapy (i.e. use of disease modifying agents, corticosteroids, or immunosuppressive drugs) in past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug. (topical, ocular, inhaled or nasal steroids or adrenal replacement therapy of <=10 mg prednisone equivalents is permitted in the absence of active auto-immune disease);
- Currently receiving study treatment in other clinical trials. Subjects who have participated in clinical trials (including trials of investigational vaccines), and received interventional and investigational treatment with invasive and investigational medical devices within 4 weeks prior to the start of the study treatment;
- Subjects who have received major surgeries or experienced severe traumas within 4 weeks prior to the initiation of treatment, or those who are recovering from such surgeries or traumas but the study results will be affected in the opinion of the investigator, or those who have scheduled to undergo surgeries during their participation in the study.
- Therapy to the lung that is >30Gy within 6 months of the first dose of trial treatment. Has received prior radiotherapy within 2 weeks of start of study treatment. or have had a history of radiation pneumonitis.
- Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- Hepatitis B:
- Hepatitis C: hepatitis C virus (HCV) antibody positive and meantime HCV RNA [qualitative] is detected.
- Known positive human immunodeficiency virus (HIV) serum reaction.
- With uncontrollable hydrothorax or ascites.
- Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
- Clinically significant cardiovascular disease including but not limited to:
- Clinically significant gastrointestinal disorders including:
- Deep vein thrombosis within 6 months prior to the initiation of treatment (except for the case where warfarin has not been used for anti-coagulation for more than 2 weeks prior to treatment initiation).
- Thrombolytic therapy (except for the maintenance of an IV catheter) within 10 days prior to treatment initiation.
- History of uncontrolled seizures within 6 months prior to the first dose of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Open-label Phase II Clinical Trial of TJ271 Injection in Combination With Pembrolizumab in Chinese Patients With Advanced Solid Tumors
A Multi-center, Open-label Phase II Clinical Trial of TJ271 Injection in Combination with Pembrolizumab in Chinese Patients with Advanced Solid Tumors to evaluate the anti-tumor efficacy, safety, pharmacokinetics and immunogenicity of TJ271 in combination with pembrolizumab in patients with advanced solid tumors.
Read the detailed description
A Multi-center, Open-label Phase II Clinical Trial of TJ271 Injection in Combination with Pembrolizumab in Chinese Patients with Advanced Solid Tumors to evaluate the anti-tumor efficacy, safety, pharmacokinetics and immunogenicity of TJ271 in combination with pembrolizumab in patients with advanced solid tumors.
- Conditions
- First-line Non-small-cell Lung Cancer, First-line Urothelial Carcinoma, Second-line Urothelial Carcinoma, Second-line Melanoma
- Being tested
- TJ271 Injection in Combination with Pembrolizumab
- Keywords
- Evaluate the anti-tumor Efficacy, Safety, Tolerability,Pharmacokinetics and Immunogenicity, A Multi-center, Open-label Phase II Clinical Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ271 Injection in Combination with PembrolizumabDrug
TJ271 Injection: 0.9% sodium chloride solution Pembrolizumab: 0.9% sodium chloride solution or 5% glucose solution
| Study group | Role | What they receive |
|---|---|---|
| TJ271 Injection in Combination with Pembrolizumab | Experimental | TJ271 Injection: 0.9% sodium chloride solution Pembrolizumab: 0.9% sodium chloride solution or 5% glucose solution Receives: Drug: TJ271 Injection in Combination with Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
To evaluate the anti-tumor efficacy of TJ271 in combination with pembrolizumab in patients with advanced solid tumors, i.e. to evaluate the Objective Response Rate (ORR) as per RECIST 1.1 criteria
Measured: approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start31 Dec 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Why it stopped: Company Development strategy adjustment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First-line Non-small-cell Lung 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT05338580
- Sponsor's protocol ID
- TJ271001STM202
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2022
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Multi-center, Open-label Phase II Clinical Trial of TJ271 Injection in Combination With Pembrolizumab in Chinese Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05338580
- Acronym / sponsor ID
- TJ271001STM202
- Conditions
- First-line Non-small-cell Lung Cancer, First-line Urothelial Carcinoma, Second-line Urothelial Carcinoma, Second-line Melanoma
- Keywords
- Evaluate the anti-tumor Efficacy, Safety, Tolerability,Pharmacokinetics and Immunogenicity, A Multi-center, Open-label Phase II Clinical Trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company Development strategy adjustment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TJ Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Apr 2022 (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 Multi-center, Open-label Phase II Clinical Trial of TJ271 Injection in Combination with Pembrolizumab in Chinese Patients with Advanced Solid Tumors to evaluate the anti-tumor efficacy, safety, pharmacokinetics and immunogenicity of TJ271 in combination with pembrolizumab in patients with advanced solid tumors.
Detailed description
A Multi-center, Open-label Phase II Clinical Trial of TJ271 Injection in Combination with Pembrolizumab in Chinese Patients with Advanced Solid Tumors to evaluate the anti-tumor efficacy, safety, pharmacokinetics and immunogenicity of TJ271 in combination with pembrolizumab in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TJ271 Injection in Combination with Pembrolizumab | Experimental | Drug: TJ271 Injection in Combination with PembrolizumabTJ271 Injection: 0.9% sodium chloride solution Pembrolizumab: 0.9% sodium chloride solution or 5% glucose solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Volunteer to participate in the clinical study; fully understand and sign the written ICF; willing to follow and able to complete all trial procedures.
- Males or females aged => 18 years (inclusive) at the time of signing informed consent.
- With histologically or cytologically confirmed diagnosis of NSCLC, urothelial carcinoma, or melanoma;
- Subjects have at least 1 measurable lesion as defined by RECIST 1.1 (not reside in a field that has been subjected to prior radiotherapy; if within the radiotherapy field, clear evidence of radiographic progression since 14 days after the completion of prior radiotherapy and prior to study enrollment).
- Provide at least 5 unstained tissue sections; with tumor expression levels of PD-L1, CD73, and B7-H3 (central laboratory test) assessed by IHC; the enrollment of NSCLC cohort can be based on the PD-L1 TPS detection level tested by the local laboratory (see 10.5.1.2 Tumor Tissue Sample-Related Biomarkers for details).
Key exclusion criteria (24 listed)
- Diseases amenable to a local curative treatment approach.
- Exclusion criteria for each cohort on prior systemic therapy
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137, B7H3). (Melanoma indications is somewhat special, see inclusion criteria 3.4; if patients received prior CTLA- and discontinued due an irAE, this would be excluded).
- Pregnant or lactating women, or expected to become pregnant or give birth to a child during the study.
- Have received systemic anti-tumor therapy including investigational agents within 4 weeks prior to the start of the study treatment or within five half-lives of the study drug, whichever is shorter.
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 |
|---|---|---|
| TJ271 Injection in Combination with PembrolizumabTJ271 Injection: 0.9% sodium chloride solution Pembrolizumab: 0.9% sodium chloride solution or 5% glucose solution | Drug | TJ271 Injection in Combination with Pembrolizumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: approximately 2 years
To evaluate the anti-tumor efficacy of TJ271 in combination with pembrolizumab in patients with advanced solid tumors, i.e. to evaluate the Objective Response Rate (ORR) as per RECIST 1.1 criteria
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TJ271 Injection in Combination with Pembrolizumab in people with First-line Non-small-cell Lung Cancer and First-line Urothelial Carcinoma, run by TJ Biopharma Co., Ltd. at 1 site 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 9 inclusion and 24 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: withdrawn, 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 1 site 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Objective Response Rate (ORR) (time frame: approximately 2 years). 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.