Solid TumorsPhase 1/2NCT06386146
JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
A Phase 1/2 study testing JAB-30355 in people with Solid Tumors, run by Jacobio Pharmaceuticals Co., Ltd. at 15 sites in 2 countries.
Trial summary
This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- JAB-30355
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 24 Jul 2024to Jul 2027
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
- ECOG performance status score of 0 or 1.
- Has been treated with at least one line of systemic therapy for that tumor type and stage.
- Have documentation of confirmed TP53 Y220C mutation.
- At least 1 measurable lesion per RECIST v1.1.
- Adequate hematological, renal and hepatic function and appropriate coagulation condition.
- Able to swallow and retain orally administered medication.
Who cannot join
- Active brain or spinal metastases or primary CNS tumor.
- Active infection requiring systemic treatment within 7 days.
- Active HBV or HCV.
- Any severe and/or uncontrolled medical conditions.
- LVEF ≤50% assessed by ECHO or MUGA.
- QTcF > 470 msec.
Trial locations and contacts
15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 2 countries
China8 sites, 8 recruiting
- Recruiting
Research Site
Beijing, Beijing Municipality, 100000
- Recruiting
Research Site
Beijing, Beijing Municipality, 100021
- Recruiting
Research Site
Beijing, Beijing Municipality, 100142
- Recruiting
Research Site
Guangzhou, Guangdong, 510000
- Recruiting
Research Site
Jinan, Shandong, 250117
- Recruiting
Research Site
Shanghai, Shanghai Municipality, 200032
- Recruiting
Research Site
Shenyang, Liaoning, 110801
- Recruiting
Research Site
Zhengzhou, Henan, 451191
United States7 sites, 5 recruiting
- Terminated
Research site
Canton, Ohio, 44718
- Recruiting
Research site
Cleveland, Ohio, 44195
- Recruiting
Research Site
Denver, Colorado, 80218
- Recruiting
Research site
Houston, Texas, 77030
- Terminated
Research site
Lake Mary, Florida, 32771
- Recruiting
Research Site
Nashville, Tennessee, 37203
- Recruiting
Research site
St Louis, Missouri, 63110
About this study
Official title: A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-30355 in Adult Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
This study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
Read the detailed description
This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). The primary objective of dose escalation is to evaluate the safety and tolerability, and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation. Dose expansion will further explore JAB-30355's clinical benefit and tolerability in selected dose levels.
- Conditions
- Solid Tumors
- Being tested
- JAB-30355
- Keywords
- TP53 Y220C reactivator; TP53 Y220C mutation; P53; Tumor protein p53; TP53; Advanced solid tumors; Ovarian Cancer; JAB-30355
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JAB-30355Drug
Oral administration
JAB-30355Drug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation phase | Experimental | Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD) Receives: Drug: JAB-30355 |
| Dose expansion phase | Experimental | Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level. Receives: Drug: JAB-30355 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT)
Number and proportion of participants who experience at least one dose limiting toxicity (DLT)
Measured: Approximately one year
Number of participants with adverse events
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms et al.
Measured: Approximately three years
Secondary outcomes (5)
Peak Plasma Concentration (Cmax)
Observed maximum plasma concentration after administration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.
Measured: Approximately three years
Time to reach the observed maximum (peak) concentration (Tmax)
Time to reach the observed maximum (peak) concentration. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.
Measured: Approximately three years
Terminal half-life (t1/2)
Terminal half-life of JAB-30355 in human. Plasma concentrations of JAB-30355 from subjects will be used to calculate PK parameters.
Measured: Approximately three years
Objective response rate (ORR)
ORR is defined as the percentage of participants with partial response (PR) or complete response (CR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Measured: Approximately three years
Duration of response (DOR)
DOR is defined as the time from the date of the first documented response (CR or PR) to the earliest date of disease progression or death, whichever occurs first, as determined by investigator assessment per RECIST v1.1.
Measured: Approximately three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start24 Jul 2024
- Primary completionJan 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386146
- Sponsor's protocol ID
- JAB-30355-1001
- Status last verified
- May 2026
- First submitted
- 23 Apr 2024
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-30355 in Adult Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
- ClinicalTrials.gov ID
- NCT06386146
- Acronym / sponsor ID
- JAB-30355-1001
- Conditions
- Solid Tumors
- Keywords
- TP53 Y220C reactivator; TP53 Y220C mutation; P53; Tumor protein p53; TP53; Advanced solid tumors; Ovarian Cancer; JAB-30355
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Jacobio Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 Apr 2024 (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 study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
Detailed description
This study consists of two parts: Dose Escalation Phase (Phase 1) and Dose Expansion Phase (Phase 2a). The primary objective of dose escalation is to evaluate the safety and tolerability, and to determine the MTD of JAB-30355 monotherapy administered in participants with advanced solid tumors harboring TP53 Y220C mutation. Dose expansion will further explore JAB-30355's clinical benefit and tolerability in selected dose levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose escalation phase | Experimental | Drug: JAB-30355Multiple dose levels of JAB-30355 will be explored to determine the maximum tolerated dose (MTD) |
| Dose expansion phase | Experimental | Drug: JAB-30355Dose Expansion Phase will explore JAB-30355's clinical benefit and optimal tolerability in selected dose level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Written informed consent.
- Participant must be ≥18 years of age at the time of signing the Informed Consent Form (ICF).
- ECOG performance status score of 0 or 1.
- Has been treated with at least one line of systemic therapy for that tumor type and stage.
- Have documentation of confirmed TP53 Y220C mutation.
Key exclusion criteria (6 listed)
- Active brain or spinal metastases or primary CNS tumor.
- Active infection requiring systemic treatment within 7 days.
- Active HBV or HCV.
- Any severe and/or uncontrolled medical conditions.
- LVEF ≤50% assessed by ECHO or MUGA.
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-30355Oral administration | Drug | Dose escalation phase |
| JAB-30355Oral administration | Drug | Dose expansion phase |
Primary outcome
Dose limiting toxicity (DLT)
Time frame: Approximately one year
Number and proportion of participants who experience at least one dose limiting toxicity (DLT)
Number of participants with adverse events
Time frame: Approximately three years
All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms et al.
5 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: Approximately three years
Time to reach the observed maximum (peak) concentration (Tmax)
Time frame: Approximately three years
Terminal half-life (t1/2)
Time frame: Approximately three years
Objective response rate (ORR)
Time frame: Approximately three years
Duration of response (DOR)
Time frame: Approximately three 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 22 May 2026.
Related trials for Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
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.
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing JAB-30355 in people with Solid Tumors, run by Jacobio Pharmaceuticals Co., Ltd. at 15 sites in 2 countries.
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 8 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: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China, United States. 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?
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?
Contact Jacobio Pharmaceuticals (781-918-6670, clinicaltrials@jacobiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) (time frame: Approximately one year). 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 22 May 2026.