Advanced Solid TumorPhase 1/2NCT04721223
JAB-3068 Activity in Adult Patients With Advanced Solid Tumors
A Phase 1/2 study testing JAB-3068 and PD1 inhibitor in people with Advanced Solid Tumor and Esophageal Squamous Cell Carcinoma, run by Jacobio Pharmaceuticals Co., Ltd. at 3 sites in China.
Trial summary
To evaluate the safety and tolerability of JAB-3068 administered in investigational regimens in adult participants with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Esophageal Squamous Cell Carcinoma, Non Small Cell Lung Cancer
- What is being tested?
- JAB-3068 and PD1 inhibitor
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesChina
- Study dates
- 26 Apr 2021to 29 Dec 2023
- 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
- Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses.
- Participant must be ≥18 years of age at the time of signature of the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Who cannot join
- History (≤3 years) of cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer
- Known serious allergy to experimental drugs
- Brain or spinal metastases, except if treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage for ≤21 days before the start of treatment with the study drugs, and has not received any systemic corticosteroids for ≥21 days before the start of treatment with the study drugs
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Henan Cancer Hospital
Zhengzhou, Henan
About this study
Official title: A Phase 1b/2a, Multi-Center, Open-Label，Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of JAB-3068 in Combination With JS001 in Patients With Advanced Solid Tumors
To evaluate the safety and tolerability of JAB-3068 administered in investigational regimens in adult participants with advanced solid tumors.
Read the detailed description
To assess the safety and tolerability and determine the recommended phase 2 dose (RP2D) of JAB-3068 in combination with PD1 inhibitor in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, Esophageal Squamous Cell Carcinoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
- Being tested
- JAB-3068, PD1 inhibitor
- Medical subject headings
- Esophageal Squamous Cell Carcinoma, Carcinoma, Non-Small-Cell Lung, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-3068Drug
JAB-3068 administrated orally as a tablet.
PD1 inhibitorDrug
JS001 administrated as an intravenous(IV) infusion.
| Study group | Role | What they receive |
|---|---|---|
| JAB-3068+PD1 inhibitor Part1 | Experimental | JAB-3068+JS001 dose escalation Receives: Drug: JAB-3068; Drug: PD1 inhibitor |
| JAB-3068+PD1 inhibitor Part2 | Experimental | JAB-3068+JS001 dose expansion Receives: Drug: JAB-3068; Drug: PD1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities
Incidence of dose limiting toxicities (DLTs) . A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3068 and JS001.
Measured: 24 months
Objective response rate (ORR)
ORR is defined as the proportion of participants with complete response or partial response (CR+PR).
Measured: 24 months
Secondary outcomes (8)
Plasma concentration (Cmax)
Highest observed plasma concentration of JAB-3068 and JS001
Measured: 24 months
Time to achieve Cmax (Tmax)
Time of highest observed plasma concentration of JAB-3068 and JS001
Measured: 24 months
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration time curve of JAB-3068 and JS001
Measured: 24 months
Duration of response ( DCR )
DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).
Measured: 24 months
Progression-free survival (PFS)
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.
Measured: 24 months
Duration of response ( DOR )
DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.
Measured: 24 months
Overall survival (OS)
OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor.
Measured: 24 months
Number of Participants with Treatment-related Adverse Events(TRAE)
TRAE is defined as the AES that the casual relationship of the AE is ralated to investigational drug.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start26 Apr 2021
- Primary completion29 Dec 2023
- Study completion29 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721223
- Sponsor's protocol ID
- JAB-3068-03
- Status last verified
- Sep 2024
- First submitted
- 14 Jan 2021
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a, Multi-Center, Open-Label，Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of JAB-3068 in Combination With JS001 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04721223
- Acronym / sponsor ID
- JAB-3068-03
- Conditions
- Advanced Solid Tumor, Esophageal Squamous Cell Carcinoma, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- AbbVie
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 29 Dec 2023 (actual)
- First posted
- 22 Jan 2021 (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.
To evaluate the safety and tolerability of JAB-3068 administered in investigational regimens in adult participants with advanced solid tumors.
Detailed description
To assess the safety and tolerability and determine the recommended phase 2 dose (RP2D) of JAB-3068 in combination with PD1 inhibitor in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JAB-3068+PD1 inhibitor Part1 | Experimental | Drug: JAB-3068, Drug: PD1 inhibitorJAB-3068+JS001 dose escalation |
| JAB-3068+PD1 inhibitor Part2 | Experimental | Drug: JAB-3068, Drug: PD1 inhibitorJAB-3068+JS001 dose expansion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses.
- Participant must be ≥18 years of age at the time of signature of the informed consent form (ICF).
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Key exclusion criteria (3 listed)
- History (≤3 years) of cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer
- Known serious allergy to experimental drugs
- Brain or spinal metastases, except if treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage for ≤21 days before the start of treatment with the study drugs, and has not received any systemic corticosteroids for ≥21 days before the start of treatment with the study drugs
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 |
|---|---|---|
| JAB-3068JAB-3068 administrated orally as a tablet. | Drug | JAB-3068+PD1 inhibitor Part1, JAB-3068+PD1 inhibitor Part2 |
| PD1 inhibitorJS001 administrated as an intravenous(IV) infusion. | Drug | JAB-3068+PD1 inhibitor Part1, JAB-3068+PD1 inhibitor Part2 |
Primary outcome
Number of participants with dose limiting toxicities
Time frame: 24 months
Incidence of dose limiting toxicities (DLTs) . A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-3068 and JS001.
Objective response rate (ORR)
Time frame: 24 months
ORR is defined as the proportion of participants with complete response or partial response (CR+PR).
8 secondary outcomes
Plasma concentration (Cmax)
Time frame: 24 months
Time to achieve Cmax (Tmax)
Time frame: 24 months
Area under the plasma concentration-time curve (AUC)
Time frame: 24 months
Duration of response ( DCR )
Time frame: 24 months
Progression-free survival (PFS)
Time frame: 24 months
Duration of response ( DOR )
Time frame: 24 months
Overall survival (OS)
Time frame: 24 months
Number of Participants with Treatment-related Adverse Events(TRAE)
Time frame: 24 months
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 19 Sep 2024.
- 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.
3 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 JAB-3068 and PD1 inhibitor in people with Advanced Solid Tumor and Esophageal Squamous Cell Carcinoma, run by Jacobio Pharmaceuticals 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?
The sponsor lists 3 inclusion and 3 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 19 Sep 2024. 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 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?
Number of participants with dose limiting toxicities (time frame: 24 months). 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 19 Sep 2024.