Advanced Malignant TumorPhase 1NCT06022250
The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
A Phase 1 study testing JS207 in people with Advanced Malignant Tumor, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK),Pharmacodynamic characteristics, immunogenicity and antitumor activity of JS207 in patients with advanced malignant tumor. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Malignant Tumor
- What is being tested?
- JS207
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteChina
- Study dates
- 26 Sep 2023to 30 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with advanced malignant tumor confirmed by histology or pathology, failed by standard treatment, no standard treatment or no standard treatment is applicable;
- Eastern Cooperative Oncology Group (ECOG) 0 or 1;
- Life expectancy ≥ 12 weeks;
- At least one measurable lesion according to RECIST 1.1;
- Adequate organ function;
Who cannot join
- central nervous system metastasis；
- There is a pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc.)；
- Images in screening showed that the tumor surrounded important blood vessels or had obvious necrosis and voids, and the investigators believed that it might cause bleeding risk；
- The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures；
- A history of significant bleeding tendency or severe coagulopathy；
- The presence of poorly controlled hypertension；
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117
About this study
Official title: A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK),Pharmacodynamic characteristics, immunogenicity and antitumor activity of JS207 in patients with advanced malignant tumor. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics.
- Conditions
- Advanced Malignant Tumor
- Being tested
- JS207
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS207Drug
Patients will receive specific dose of JS207 via intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| JS207 | Experimental | Not described Receives: Drug: JS207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity （DLT）、adverse event（AE）
Incidence and severity of DLT, adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance
Measured: 2 Years
Maximum tolerated dose (MTD),RP2D
Maximum tolerated dose (MTD), Recommended dose for phase II trial
Measured: 2 Years
Secondary outcomes (7)
Peak concentration（Cmax）
The highest plasma drug concentration that can be achieved after medication
Measured: 2 years
Time to peak（Tmax）
After a single dose, the time of peak blood concentration
Measured: 2 years
Elimination half life（t1/2）
The time it takes the blood to reduce the concentration of the drug to half
Measured: 2 years
Progression free survival(PFS)
The time from first dose to Disease progression or death
Measured: 2 years
Overall survival (OS)
The time from first dose to death from any cause
Measured: 2 years
Immunogenicity
Incidence of Anti-Drug Antibody (ADA)
Measured: 2 years
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start26 Sep 2023
- Primary completion8 Apr 2026
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant TumorStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06022250
- Sponsor's protocol ID
- JS207-001-I
- Status last verified
- Jul 2026
- First submitted
- 23 Aug 2023
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
- ClinicalTrials.gov ID
- NCT06022250
- Acronym / sponsor ID
- JS207-001-I
- Conditions
- Advanced Malignant Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Collaborators
- Sponsor GmbH
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 1 Sep 2023 (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 Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK),Pharmacodynamic characteristics, immunogenicity and antitumor activity of JS207 in patients with advanced malignant tumor. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JS207 | Experimental | Drug: JS207 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with advanced malignant tumor confirmed by histology or pathology, failed by standard treatment, no standard treatment or no standard treatment is applicable;
- Eastern Cooperative Oncology Group (ECOG) 0 or 1;
- Life expectancy ≥ 12 weeks;
- At least one measurable lesion according to RECIST 1.1;
- Adequate organ function;
Key exclusion criteria (6 listed)
- central nervous system metastasis；
- There is a pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc.)；
- Images in screening showed that the tumor surrounded important blood vessels or had obvious necrosis and voids, and the investigators believed that it might cause bleeding risk；
- The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures；
- A history of significant bleeding tendency or severe coagulopathy；
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 |
|---|---|---|
| JS207Patients will receive specific dose of JS207 via intravenous infusion. | Drug | JS207 |
Primary outcome
Dose-limiting toxicity （DLT）、adverse event（AE）
Time frame: 2 Years
Incidence and severity of DLT, adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance
Maximum tolerated dose (MTD),RP2D
Time frame: 2 Years
Maximum tolerated dose (MTD), Recommended dose for phase II trial
7 secondary outcomes
Peak concentration（Cmax）
Time frame: 2 years
Time to peak（Tmax）
Time frame: 2 years
Elimination half life（t1/2）
Time frame: 2 years
Progression free survival(PFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Immunogenicity
Time frame: 2 years
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No
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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 1 study testing JS207 in people with Advanced Malignant Tumor, run by Shanghai Junshi Bioscience 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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 2 Jul 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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 toxicity （DLT）、adverse event（AE） (time frame: 2 Years). The study lists 2 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 2 Jul 2026.