Advance Solid TumorsPhase 1/2PANGU-1NCT07864701
Study of JMBI-001 in Patients With MYC-Positive Advanced Cancers
A Phase 1/2 study testing JMBI-001 Tablets in people with Advance Solid Tumors and Lymphoma, Non-Hodgkin, run by Chengdu Anticancer Bioscience, Ltd. at 1 site in China.
Trial summary
Evaluate the safety and tolerability of JMBI-001 in adults with MYC-positive advanced cancers. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advance Solid Tumors, Lymphoma, Non-Hodgkin
- What is being tested?
- JMBI-001 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Jun 2030
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to fully understand the study requirements, voluntarily agree to participate in the study, and provide written informed consent.
- Male or female participants aged 18 to 75 years, inclusive.
- Histologically or cytologically confirmed malignant tumor. Participants with solid tumors must have unresectable locally advanced or metastatic disease for which standard treatment has failed, is not tolerated, or is unavailable. Participants with non-Hodgkin lymphoma must have received at least two prior lines of therapy. Tumor-specific requirements for each study phase are as follows:
- Phase Ia dose-escalation stage: Solid tumors, including but not limited to gastric cancer, colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and triple-negative breast cancer. Non-Hodgkin lymphoma, including but not limited to diffuse large B-cell lymphoma and Burkitt lymphoma.
- Phase Ib dose-expansion stage: tumor indications within prespecified tumor types of particular interest, potentially sensitive tumor types or subtypes identified during Phase Ia, or both. Prespecified tumor types of particular interest include, but are not limited to, gastric cancer, colorectal cancer, non-small cell lung cancer, hepatocellular carcinoma, and non-Hodgkin lymphoma.
- Phase II indication-expansion stage: selected tumor indications that meet the prespecified transition criteria during Phase Ib.
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- Except for participants enrolled in the accelerated titration stage of Phase Ia, tumor tissue obtained or submitted during screening must be tested by immunohistochemistry and meet the following criteria for MYC positivity:
- Solid tumors: MYC-positive tumor cell nuclei in at least 10% of tumor cells.
- Non-Hodgkin lymphoma: MYC-positive tumor cell nuclei in at least 40% of tumor cells.
- At least one lesion suitable for efficacy assessment, as follows:
- For participants with solid tumors, at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). The longest diameter must be at least 10 mm on spiral computed tomography, or the short-axis diameter of an enlarged lymph node must be at least 15 mm. A lesion selected as a target lesion must not have received radiotherapy within 4 weeks before the first dose of JMBI-001; palliative local radiotherapy to a non-target lesion is permitted.
- For participants with non-Hodgkin lymphoma, according to the Lugano 2014 criteria, the longest diameter must be greater than 1.5 cm for a nodal lesion or greater than 1.0 cm for an extranodal lesion.
Who cannot join
- Difficulty swallowing or inability to swallow tablets.
- Known hypersensitivity to any component of JMBI-001 tablets.
- Carcinomatous meningitis, brainstem metastasis, or spinal cord compression confirmed by imaging or clinical diagnosis.
- History of a severe neurologic disorder or severe psychiatric or psychological disorder that may interfere with the participant's ability to understand or comply with the study protocol.
- Systemic glucocorticoid therapy within 2 weeks before the first dose of JMBI-001 at a prednisone-equivalent dose greater than 10 mg/day.
- Gastrointestinal disease or abnormality that may affect the absorption of JMBI-001, including but not limited to celiac disease, short bowel syndrome, Crohn disease, ulcerative colitis, gastrointestinal perforation, or severe vomiting or diarrhea.
- Other Inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, 100142
Lin Shen, Medical Doctor, +86-10-88196561, doctorshenlin@sina.com
About this study
Official title: A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity and Efficacy of JMBI-001 Tablets in Participants With MYC-Positive Advanced Solid Tumors or Relapsed/Refractory Non-Hodgkin Lymphoma
Evaluate the safety and tolerability of JMBI-001 in adults with MYC-positive advanced cancers.
Read the detailed description
The purpose of this clinical trial is to investigate JMBI-001 for the treatment of MYC-positive advanced tumors and to evaluate its safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and antitumor efficacy.
The main questions this study aims to answer are:
- To evaluate the safety, tolerability, PK, and preliminary antitumor activity of JMBI-001, and to determine the recommended dose for expansion (RDE) and the recommended Phase II dose (RP2D).
- To evaluate the antitumor efficacy, safety, tolerability, and PK of JMBI-001 at the RP2D in selected tumor types.
Participants will:
- Take JMBI-001 orally once daily on an empty stomach for 4 consecutive days, followed by 3 days without treatment. Three such 7-day dosing periods will constitute one 21-day treatment cycle.
- Visit the study site as scheduled to undergo protocol-specified procedures, including medical interviews, physical examinations, blood tests, electrocardiograms, and imaging examinations.
- Continue treatment until a protocol-defined event requiring discontinuation of study treatment or withdrawal from the study occurs.
- Conditions
- Advance Solid Tumors, Lymphoma, Non-Hodgkin
- Being tested
- JMBI-001 Tablets
- Keywords
- MYC-Positive Tumor, MKLP2, KIF20A, JMBI-001, MYC, Anticancer Bioscience
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMBI-001 TabletsDrug
JMBI-001 will be administered orally once daily on an empty stomach for 4 consecutive days, followed by 3 days without treatment, in repeated 21-day treatment cycles. Dose levels will be determined according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| JMBI-001 Monotherapy | Experimental | Participants will receive JMBI-001 orally once daily on an empty stomach for 4 consecutive days, followed by 3 days without treatment. Each 21-day treatment cycle consists of three consecutive 7-day dosing periods. Receives: Drug: JMBI-001 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ia: dose-limiting toxicities (DLTs)
Measured: Cycle 1, Days 1-21 after the first dose (21-day DLT assessment period)
Phase Ia: maximum tolerated dose (MTD)
Measured: At completion of Phase Ia dose escalation, after completion of the 21-day DLT assessment period for each dose cohort, up to approximately 15 months after the first participant receives the first dose.
Phase 1a：recommended dose for expansion (RDE)
Measured: At completion of Phase Ia dose escalation, after review of DLTs and other available safety data, up to approximately 15 months after the first participant receives the first dose.
Phase Ia/Ib: adverse events (AEs), serious adverse events (SAEs)
Measured: From informed consent, during each 21-day treatment cycle, at the end-of-treatment visit (within 7 days of treatment discontinuation), and through 30 days after the last dose or until new anticancer therapy starts, whichever occurs first
Phase Ib: determination of the recommended Phase II dose (RP2D)
Measured: From the first dose administered to the first participant in Phase Ia through completion of Phase Ib dose expansion, up to approximately 27 months.
Phase II: Objective response rate (ORR)
Measured: From baseline until disease progression, initiation of new anticancer therapy, or withdrawal, assessed up to approximately 24 months.
Secondary outcomes (10)
Phase Ia/Ib/II: maximum plasma concentration (Cmax)
Measured: During the first cycle of treatment (21 days)
Phase Ia/Ib/II: time to maximum plasma concentration (Tmax)
Measured: During the first cycle of treatment (21 days)
Phase Ia/Ib/II: area under the concentration-time curve (AUC)
Measured: During the first cycle of treatment (21 days)
Phase Ia/Ib/II: elimination half-life (t1/2)
Measured: During the first cycle of treatment (21 days)
Phase II: Disease Control Rate (DCR)
Measured: From baseline until disease progression, initiation of new anticancer therapy, or withdrawal, assessed up to approximately 24 months.
Phase II: adverse events (AEs), serious adverse events (SAEs)
Measured: From informed consent, during each 21-day treatment cycle, at the end-of-treatment visit (within 7 days of treatment discontinuation), and through 30 days after the last dose or until new anticancer therapy starts, whichever occurs first.
Phase II: Progression-Free Survival (PFS)
Measured: From the first dose until disease progression or death from any cause, whichever occurs first, assessed up to approximately 24 months.
Duration of Response (DoR)
Measured: From the first documented CR or PR until disease progression or death from any cause, whichever occurs first, assessed up to approximately 24 months.
Phase II: Time to Response (TTR)
Measured: From the first dose until the first documented CR or PR, assessed up to approximately 24 months.
Phase II: Time to Progression (TTP)
Measured: From the first dose until disease progression, assessed up to approximately 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advance 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Anticancer Bioscience, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864701
- Sponsor's protocol ID
- PANGU-1
- Other IDs
- CTR20263562
- Acronym
- PANGU-1
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity and Efficacy of JMBI-001 Tablets in Participants With MYC-Positive Advanced Solid Tumors or Relapsed/Refractory Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07864701
- Acronym / sponsor ID
- PANGU-1 / PANGU-1
- Conditions
- Advance Solid Tumors, Lymphoma, Non-Hodgkin
- Keywords
- MYC-Positive Tumor, MKLP2, KIF20A, JMBI-001, MYC, Anticancer Bioscience
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chengdu Anticancer Bioscience, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 8 Oct 2026 (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.
Evaluate the safety and tolerability of JMBI-001 in adults with MYC-positive advanced cancers.
Detailed description
The purpose of this clinical trial is to investigate JMBI-001 for the treatment of MYC-positive advanced tumors and to evaluate its safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and antitumor efficacy.
The main questions this study aims to answer are:
- To evaluate the safety, tolerability, PK, and preliminary antitumor activity of JMBI-001, and to determine the recommended dose for expansion (RDE) and the recommended Phase II dose (RP2D).
- To evaluate the antitumor efficacy, safety, tolerability, and PK of JMBI-001 at the RP2D in selected tumor types.
Participants will:
- Take JMBI-001 orally once daily on an empty stomach for 4 consecutive days, followed by 3 days without treatment. Three such 7-day dosing periods will constitute one 21-day treatment cycle.
- Visit the study site as scheduled to undergo protocol-specified procedures, including medical interviews, physical examinations, blood tests, electrocardiograms, and imaging examinations.
- Continue treatment until a protocol-defined event requiring discontinuation of study treatment or withdrawal from the study occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JMBI-001 Monotherapy | Experimental | Drug: JMBI-001 TabletsParticipants will receive JMBI-001 orally once daily on an empty stomach for 4 consecutive days, followed by 3 days without treatment. Each 21-day treatment cycle consists of three consecutive 7-day dosing periods. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able to fully understand the study requirements, voluntarily agree to participate in the study, and provide written informed consent.
- Male or female participants aged 18 to 75 years, inclusive.
- Histologically or cytologically confirmed malignant tumor. Participants with solid tumors must have unresectable locally advanced or metastatic disease for which standard treatment has failed, is not tolerated, or is unavailable. Participants with non-Hodgkin lymphoma must have received at least two prior lines of therapy. Tumor-specific requirements for each study phase are as follows:
- Except for participants enrolled in the accelerated titration stage of Phase Ia, tumor tissue obtained or submitted during screening must be tested by immunohistochemistry and meet the following criteria for MYC positivity:
- At least one lesion suitable for efficacy assessment, as follows:
Key exclusion criteria (7 listed)
- Difficulty swallowing or inability to swallow tablets.
- Known hypersensitivity to any component of JMBI-001 tablets.
- Carcinomatous meningitis, brainstem metastasis, or spinal cord compression confirmed by imaging or clinical diagnosis.
- History of a severe neurologic disorder or severe psychiatric or psychological disorder that may interfere with the participant's ability to understand or comply with the study protocol.
- Systemic glucocorticoid therapy within 2 weeks before the first dose of JMBI-001 at a prednisone-equivalent dose greater than 10 mg/day.
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 |
|---|---|---|
| JMBI-001 TabletsJMBI-001 will be administered orally once daily on an empty stomach for 4 consecutive days, followed by 3 days without treatment, in repeated 21-day treatment cycles. Dose levels will be determined according to the study protocol. | Drug | JMBI-001 Monotherapy |
Primary outcome
Phase Ia: dose-limiting toxicities (DLTs)
Time frame: Cycle 1, Days 1-21 after the first dose (21-day DLT assessment period)
Phase Ia: maximum tolerated dose (MTD)
Time frame: At completion of Phase Ia dose escalation, after completion of the 21-day DLT assessment period for each dose cohort, up to approximately 15 months after the first participant receives the first dose.
Phase 1a：recommended dose for expansion (RDE)
Time frame: At completion of Phase Ia dose escalation, after review of DLTs and other available safety data, up to approximately 15 months after the first participant receives the first dose.
Phase Ia/Ib: adverse events (AEs), serious adverse events (SAEs)
Time frame: From informed consent, during each 21-day treatment cycle, at the end-of-treatment visit (within 7 days of treatment discontinuation), and through 30 days after the last dose or until new anticancer therapy starts, whichever occurs first
Phase Ib: determination of the recommended Phase II dose (RP2D)
Time frame: From the first dose administered to the first participant in Phase Ia through completion of Phase Ib dose expansion, up to approximately 27 months.
Phase II: Objective response rate (ORR)
Time frame: From baseline until disease progression, initiation of new anticancer therapy, or withdrawal, assessed up to approximately 24 months.
10 secondary outcomes
Phase Ia/Ib/II: maximum plasma concentration (Cmax)
Time frame: During the first cycle of treatment (21 days)
Phase Ia/Ib/II: time to maximum plasma concentration (Tmax)
Time frame: During the first cycle of treatment (21 days)
Phase Ia/Ib/II: area under the concentration-time curve (AUC)
Time frame: During the first cycle of treatment (21 days)
Phase Ia/Ib/II: elimination half-life (t1/2)
Time frame: During the first cycle of treatment (21 days)
Phase II: Disease Control Rate (DCR)
Time frame: From baseline until disease progression, initiation of new anticancer therapy, or withdrawal, assessed up to approximately 24 months.
Phase II: adverse events (AEs), serious adverse events (SAEs)
Time frame: From informed consent, during each 21-day treatment cycle, at the end-of-treatment visit (within 7 days of treatment discontinuation), and through 30 days after the last dose or until new anticancer therapy starts, whichever occurs first.
Phase II: Progression-Free Survival (PFS)
Time frame: From the first dose until disease progression or death from any cause, whichever occurs first, assessed up to approximately 24 months.
Duration of Response (DoR)
Time frame: From the first documented CR or PR until disease progression or death from any cause, whichever occurs first, assessed up to approximately 24 months.
Phase II: Time to Response (TTR)
Time frame: From the first dose until the first documented CR or PR, assessed up to approximately 24 months.
Phase II: Time to Progression (TTP)
Time frame: From the first dose until disease progression, assessed up to approximately 24 months.
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 15 Oct 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.
1 site 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 JMBI-001 Tablets in people with Advance Solid Tumors and Lymphoma, Non-Hodgkin, run by Chengdu Anticancer Bioscience, 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 12 inclusion and 7 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 15 Oct 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 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 Clinical Trial Information Team (+86 28 85185225, JMBIClinicalTrials@anticancerbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ia: dose-limiting toxicities (DLTs) (time frame: Cycle 1, Days 1-21 after the first dose (21-day DLT assessment period)). The study lists 6 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 15 Oct 2026.