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Advanced Solid TumorEarly Phase 1MPT0B64NCT04294875

Phase I, FIH, MTD for MPT0B640, Multi-centre, Open-label, Subject With Locally Advanced or Metastatic Solid Malignancies

A Early Phase 1 study testing MPT0B640 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by J Ints Bio.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Phase l, First in Human, Multi-centre, Open-label, Clinical Trial of MPT0B640 in Subject with Locally Advanced or Metastatic Solid Malignancies Phase I. Advanced or metastatic solid malignancy First in Human. HSP90 inhibitor Multi-center clinical trials. Open label. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor, Metastatic Solid Tumor
What is being tested?
MPT0B640
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2025to Nov 2027
Phase
Early Phase 1
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

  • Subjects must meet all inclusion criteria as listed below:
  • Histologically or cytologically confirmed, locally advanced or metastatic solid malignancies, such as non-small cell lung cancer (NSCLC), breast cancer, hepatocellular carcinoma, colorectal, prostate and pancreatic cancer who is not suitable for surgery or radiotherapy.
  • Subjects who have progressed after receiving all available standard treatment known to confer clinical benefit or for which no effective therapy exists.
  • Radiological documentation of disease progression while on a previous treatment.
  • Discontinued all previous treatment for cancer for at least 14 days and recovered from the effects of therapy.
  • Eastern Cooperative Oncology Group (ECOG) 0 ~ 1
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  • 19 years and older of age (Adult)
  • At least one measurable lesion by Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
  • Laboratory values: Hematologic parameters must be met without recent transfusions within 7 days of enrolment.
  • Serum creatinine < 1.5× upper limit of normal (ULN) or if higher than normal range, calculated creatinine clearance (CrCl) must be ≥ 60mL/min/1.73m2 (by Cockroft-Gault formula); actual body weight must be used for CrCl unless body mass index (BMI) > 30kg/m2 then lean body weight must be used
  • Total bilirubin ≤ 1.5×ULN (except for Gilbert's syndrome which will allow bilirubin ≤2.0 ×ULN).
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5×ULN, or ≤ 5×ULN if due to liver involvement by tumour.
  • Haemoglobin ≥ 9.0g/dL.
  • Platelets ≥ 100×109cells/L.
  • Absolute neutrophil count ≥ 1.5×109cells/L.
  • Subjects signed informed contents form
  • Expected lifespan ≥ 3 months
  • Female should be using adequate contraceptive measures, e.g., use at least two of the following types of appropriate and effective birth control from 2 weeks prior to the first dose of the study drug until 90 days after last dose. One of these methods must be a double barrier method (condom with diaphragm plus spermicidal agent [foam/gel/cream/film/suppository]). Additional methods are IUD or IUS, vasectomy by sole male partner and use of approved oral, injected, or implanted hormonal methods of contraception.
  • Female should not breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential at screening.
  • Male subjects should be willing to use barrier contraception include using one of the following during the study and for 90 days after last dose of the study drug. (Abstinence, condom plus spermicidal agents [foam gel/cream/film/suppository])
  • Exclusion Criteria Any subject meeting one or more of the following exclusion criteria may not be entered into the trial.
  • Symptomatic central nervous system (CNS) metastases which are neurologically unstable or requiring increasing doses of steroids within the 28 days prior to study entry to control their CNS disease and require local CNS-directed therapy
  • Systemic anticancer treatment 14 days prior to the first dose of study drug on Visit 1
  • Subjects who have undergone any major surgery* (as judged by the investigator, excluding placement of vascular access) ≤ 28 days of the first dose of study drug on Visit 1 or who have not recovered from side effects of such therapy
  • Major surgery defined as a surgical operation within or upon the contents of the abdominal, pelvic, cranial or thoracic cavities and a procedure which given the locality, condition of patient, level of difficulty or length of time to perform, constitutes a hazard to life or function of an organ or tissue. Major surgery usually requires general anesthesia, a period of hospitalization of varying length (often a week) and may be performed by a surgical subspecialist.
  • Limited-field radiotherapy ≤ 7 days or extended-field thoracic radiotherapy < 28 days of study drug on Visit 1
  • Subjects with
  • A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval > 480 milliseconds (ms) (CTCAE grade 1) using Frederica's QT correction formula.
  • A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family history of Long QT Syndrome).
  • The use of concomitant medications that prolong the QT/QTc interval.
  • Subjects with impaired cardiac function or clinically significant cardiac disease such as:
  • Left ventricular ejection fraction < 50%.
  • Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade ≥ 2), uncontrolled hypertension, or clinically significant arrhythmia.
  • History of acute myocardial infarction or unstable angina pectoris < 6 months prior to study entry.
  • Subjects who had a prior history of another malignancy over the last 5 years
  • Subjects able to swallow and retain orally administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major restriction of the stomach or bowels
  • Subjects with active human immunodeficiency virus (HIV) or hepatitis B or C infection
  • Subjects who were administered another investigational product within 3 weeks prior to screening
  • Subjects with any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation.
  • Subjects with any clinically significant abnormal intestinal findings that may interfere with the administration, passage, or absorption of the investigational product, which makes the subjects unable to orally take the suspension form of drugs.
  • Subjects with drug abuse and unstable medical, psychological or social conditions that may interfere with participating in the study or assessment of the results of the study
  • Subjects with any condition or illness might compromise subject safety or interfere with the evaluation of the safety of the drug by investigator's decision
  • Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (urine or serum) pregnancy test prior to study entry
  • According to investigator's judgement, protocols cannot be followed.

Who cannot join

None listed.

About this study

Official title: Phase l, First in Human, Multi-centre, Open-label, Clinical Trial of MPT0B640 in Subject With Locally Advanced or Metastatic Solid Malignancies

Phase l, First in Human, Multi-centre, Open-label, Clinical Trial of MPT0B640 in Subject with Locally Advanced or Metastatic Solid Malignancies

Phase I. Advanced or metastatic solid malignancy First in Human. HSP90 inhibitor Multi-center clinical trials. Open label.

To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640

Read the detailed description

Classical 3+3 design to determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) of MPT0B640 .

Up to 9 times of administration, Oral suspension, once every 3rd day.

Being tested
MPT0B640
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MPT0B640Drug

    PO, every 3 days. dose escalation per MTD

Study groups in NCT04294875
Study groupRoleWhat they receive
MPT0B640OtherThere is Single Arm in this Clinical Trials.
Receives: Drug: MPT0B640

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD of the dose of MPT0B640

    Measured: 28days(+/-2days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2020
  2. Study startDec 2025 (estimated)
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Why it stopped: Study held.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04294875
Sponsor's protocol ID
JO201901-01
Acronym
MPT0B64
Status last verified
Mar 2024
First submitted
2 Mar 2020
Last updated
6 Mar 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing MPT0B640 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by J Ints Bio.

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 44 inclusion and 0 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: withdrawn, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 was withdrawn before enrolling participants, so there are no results.

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?

MTD of the dose of MPT0B640 (time frame: 28days(+/-2days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04294875.

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 6 Mar 2024.

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MPT0B64 Clinical Trial NCT04294875 | AzTrials