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

NCT04294875 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: JO201901-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor

Outcome Measures

Primary Outcomes (1)

• MTD of the dose of MPT0B640

  28days(+/-2days)

Study Arms (1)

MPT0B640

OTHER

There is Single Arm in this Clinical Trials.

Drug: MPT0B640

Interventions

MPT0B640 DRUG

PO, every 3 days. dose escalation per MTD

MPT0B640

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• J Ints Bio: lead

MeSH Terms

Conditions

Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ethan Seah

  J Ints Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2020
• First Posted: March 4, 2020
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 6, 2024

Record last verified: 2024-03