Advanced Solid TumorsPhase 1NCT04601285
A Phase I Study of JS108 in Patients With Advanced Solid Tumors
A Phase 1 study testing JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection) in people with Advanced Solid Tumors, run by Shanghai Junshi Bioscience Co., Ltd. at 3 sites in China.
Trial summary
This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS108 for patients with advanced solid tumors. This study is divided into 3 periods: dose escalation period, dose expansion period, and clinical expansion period. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesChina
- Study dates
- 28 Oct 2020to 14 Jun 2023
- 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
- Volunteer to sign an informed consent form.
- Age of 18-75 years (inclusive), male or female;
- Expected survival ≥3 months;
- Histological or cytologically confirmed locally advanced or metastatic solid tumors which progressed on standard of care or with no standard of care available;
- Toxicity of previous antitumor therapy has recovered to ≤ grade 1 as defined by the NCI-CTCAE v5.0, except alopecia;
- Subjects dose expansion period and clinical expansion period must have at least one measurable lesion in accordance with RECIST v 1.1;
- Eastern Cooperative Oncology Group (ECOG) Performance Status score: 0 or 1;
- Subjects must be able to provide fresh or archived tumor tissue obtained within 1 year prior to inclusion in the study；
- The organ function level must meet the protocol requirements；
- Serum pregnancy test confirmed as negative for women of childbearing potential within 7
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: A Phase I, Open-label, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Recombinant Humanized Anti-Trop2 mAb-Tub196 Conjugate in Patients With Advanced Solid Tumors.
This is a phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS108 for patients with advanced solid tumors. This study is divided into 3 periods: dose escalation period, dose expansion period, and clinical expansion period.
- Conditions
- Advanced Solid Tumors
- Being tested
- JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)Drug
Dose escalation period: JS108 is administered intravenously every three weeks (Q3W) at the dose corresponding to the enrolled dose cohort.
Dose expansion period: JS108 is administered intravenously Q3W at the corresponding dose.
Clinical expansion period: JS108 is administered intravenously Q3W at the recommended dose.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Not described Receives: Drug: JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Measured: A minimum of 21 days after first infusion of study drug
Number of participants with adverse events (AEs)
The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.
Measured: Through study completion, an average of 1 year
Secondary outcomes (12)
Maximum observed serum or plasma concentration (Cmax)
One of the pharmacokinetics parameters for JS108
Measured: Through study completion, an average of 1 year
Maximum serum drug time（Tmax）
One of the pharmacokinetics parameters for JS108
Measured: Through study completion, an average of 1 year
Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)
One of the pharmacokinetics parameters for JS108
Measured: Through study completion, an average of 1 year
Volume of distribution at steady state (Vss)
One of the pharmacokinetics parameters for JS108
Measured: Through study completion, an average of 1 year
Terminal phase elimination half life (t½)
One of the pharmacokinetics parameters for JS108
Measured: Through study completion, an average of 1 year
Clearance (CL)
One of the pharmacokinetics parameters for JS108
Measured: Through study completion, an average of 1 year
Anti-drug antibodies (ADA)
To evaluate the immunogenicity of JS108 in patients with advanced solid tumors
Measured: Through study completion, an average of 1 year
Objective Response Rate (ORR)
As determined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, which will be complete response (CR) + partial response (PR)
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Duration of response (DOR)
DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of PD or death due to any cause, whichever occurs first.
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the earlier of the dates of the first documentation of progressive disease or death due to any cause.
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Levels of Trop2 (trophoblast antigen 2) expression in tumor tissue
To investigate any potential correlations of Trop2 levels with responses and toxicity
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 posted23 Oct 2020
- Study start28 Oct 2020
- Primary completion14 Jun 2023
- Study completion14 Jun 2023
Why it stopped: Sponsor has adjusted study development plan and terminated this clinical study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04601285
- Sponsor's protocol ID
- JS108-001-I
- Status last verified
- Jul 2023
- First submitted
- 12 Oct 2020
- Last updated
- 6 Jul 2023
- 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 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, First-in-human, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of Recombinant Humanized Anti-Trop2 mAb-Tub196 Conjugate in Patients With Advanced Solid Tumors.
- ClinicalTrials.gov ID
- NCT04601285
- Acronym / sponsor ID
- JS108-001-I
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor has adjusted study development plan and terminated this clinical study.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 28 Oct 2020 (actual)
- Primary completion
- 14 Jun 2023 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 23 Oct 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 phase I, open-label, first-in-human clinical study designed to evaluate the safety, tolerability, PK profile and efficacy of JS108 for patients with advanced solid tumors. This study is divided into 3 periods: dose escalation period, dose expansion period, and clinical expansion period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)Dose escalation period: JS108 is administered intravenously every three weeks (Q3W) at the dose corresponding to the enrolled dose cohort. Dose expansion period: JS108 is administered intravenously Q3W at the corresponding dose. Clinical expansion period: JS108 is administered intravenously Q3W at the recommended dose. | Drug | Dose Escalation |
Primary outcome
First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD)
Time frame: A minimum of 21 days after first infusion of study drug
Number of participants that experienced dose limiting toxicities(DLTs) at given dose level.
Number of participants with adverse events (AEs)
Time frame: Through study completion, an average of 1 year
The adverse events will be evaluated in accordance with CTCAE v5.0. The investigator shall assess the relationship between the events and investigational product.
12 secondary outcomes
Maximum observed serum or plasma concentration (Cmax)
Time frame: Through study completion, an average of 1 year
Maximum serum drug time（Tmax）
Time frame: Through study completion, an average of 1 year
Area under the serum or plasma concentration time curve from 0 to infinity (AUC0-inf)
Time frame: Through study completion, an average of 1 year
Volume of distribution at steady state (Vss)
Time frame: Through study completion, an average of 1 year
Terminal phase elimination half life (t½)
Time frame: Through study completion, an average of 1 year
Clearance (CL)
Time frame: Through study completion, an average of 1 year
Anti-drug antibodies (ADA)
Time frame: Through study completion, an average of 1 year
Objective Response Rate (ORR)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Duration of response (DOR)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Progression Free Survival (PFS)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Overall Survival (OS)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year
Levels of Trop2 (trophoblast antigen 2) expression in tumor tissue
Time frame: Through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: Sponsor has adjusted study development plan and terminated this clinical study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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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.
3 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 JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection) in people with Advanced Solid Tumors, run by Shanghai Junshi Bioscience Co., Ltd. at 3 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?
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: stopped early, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was stopped early (reason given: Sponsor has adjusted study development plan and terminated this clinical study.). Results are not available in the source record.
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?
First Cycle Dose Limiting Toxicities (DLTs) In Order to Determine the Maximum Tolerated Dose(MTD) (time frame: A minimum of 21 days after first infusion of study drug). 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 6 Jul 2023.