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Not yet recruitingNCT07864701PANGU-1Updated Oct 8, 2026

Study of JMBI-001 in Patients With MYC-Positive Advanced Cancers

A Phase 1/2 interventional study of JMBI-001 Tablets in Advance Solid Tumors and Lymphoma, Non-Hodgkin, sponsored by Chengdu Anticancer Bioscience, Ltd.. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Chengdu Anticancer Bioscience, Ltd. · Phase 1/2, Interventional, and Treatment

Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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:

  1. 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).
  2. To evaluate the antitumor efficacy, safety, tolerability, and PK of JMBI-001 at the RP2D in selected tumor types.

Participants will:

  1. 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.
  2. Visit the study site as scheduled to undergo protocol-specified procedures, including medical interviews, physical examinations, blood tests, electrocardiograms, and imaging examinations.
  3. Continue treatment until a protocol-defined event requiring discontinuation of study treatment or withdrawal from the study occurs.
02

Conditions studied

  • Advance Solid Tumors
  • Lymphoma, Non-Hodgkin

Keywords

  • MYC-Positive Tumor
  • MKLP2
  • KIF20A
  • JMBI-001
  • MYC
  • Anticancer Bioscience
03

In context

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's planned enrollment of 150 is above the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

This is the only study on the registry with Chengdu Anticancer Bioscience, Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    1. 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.
    2. 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.
    3. Phase II indication-expansion stage: selected tumor indications that meet the prespecified transition criteria during Phase Ib.

  • 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:

    1. Solid tumors: MYC-positive tumor cell nuclei in at least 10% of tumor cells.
    2. 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:

    1. 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.
    2. 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.

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    JMBI-001 Monotherapy

    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.

    Drug: JMBI-001 Tablets

Interventions

  • DrugJMBI-001 Tablets

    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.

06

What researchers measure

Primary outcomes

  1. Phase Ia: dose-limiting toxicities (DLTs)

    Time frame: Cycle 1, Days 1-21 after the first dose (21-day DLT assessment period)

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

Secondary outcomes

  1. Phase Ia/Ib/II: maximum plasma concentration (Cmax)

    Time frame: During the first cycle of treatment (21 days)

  2. Phase Ia/Ib/II: time to maximum plasma concentration (Tmax)

    Time frame: During the first cycle of treatment (21 days)

  3. Phase Ia/Ib/II: area under the concentration-time curve (AUC)

    Time frame: During the first cycle of treatment (21 days)

  4. Phase Ia/Ib/II: elimination half-life (t1/2)

    Time frame: During the first cycle of treatment (21 days)

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Phase II: Time to Progression (TTP)

    Time frame: From the first dose until disease progression, assessed up to approximately 24 months.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07864701
Lead sponsor
Chengdu Anticancer Bioscience, Ltd.
Responsible party
Sponsor
First posted
Oct 8, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jun 2029 (estimated)
Completion
Jun 2030 (estimated)
Last update
Oct 8, 2026

Study contacts

Clinical Trial Information Team
Contact
JMBIClinicalTrials@anticancerbio.com
+86 28 85185225

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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