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

ConditionsAdvance Solid TumorsLymphoma, Non-Hodgkin
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChengdu Anticancer Bioscience, Ltd.

About this trial

Evaluate the safety and tolerability of JMBI-001 in adults with MYC-positive advanced cancers.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • JMBI-001 Tablets

    Drug

    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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: JMBI-001 MonotherapyExperimental treatment 1 intervention

Trial outcomes

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

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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chengdu Anticancer Bioscience, Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: