Clinical Trials /

Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors

NCT03780517

Description:

This study will be conducted to assess the safety and tolerability of BOS172738 when administered to patients with advanced solid tumors with rearranged during transfection (RET) gene alterations and also to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BOS172738.

Related Conditions:
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
  • Thyroid Gland Medullary Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Safety, Efficacy, and Tolerability of BOS172738 in Patients With Advanced Rearranged During Transfection (RET) Gene-Altered Tumors
  • Official Title: A Phase 1 Study of BOS172738 in Patients With Advanced Solid Tumors With RET Gene Alterations Including Non-Small Cell Lung Cancer (NSCLC) and Medullary Thyroid Cancer (MTC)

Clinical Trial IDs

  • ORG STUDY ID: BOS172738-01
  • SECONDARY ID: 2018-002612-27
  • NCT ID: NCT03780517

Conditions

  • Advanced Nonhaematologic Malignancies

Interventions

DrugSynonymsArms
BOS172738BOS172738

Purpose

This study will be conducted to assess the safety and tolerability of BOS172738 when administered to patients with advanced solid tumors with rearranged during transfection (RET) gene alterations and also to establish the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of BOS172738.

Trial Arms

NameTypeDescriptionInterventions
BOS172738ExperimentalIn Part A (dose escalation), participants with advanced solid tumors with rearranged during transfection (RET) gene alterations will receive oral BOS172738 at a starting dose of 10 milligrams (mg) once daily in each 28-day cycle. In Part B (dose expansion), participants with RET gene-fusion non-small cell lung cancer (NSCLC), with RET gene-mutant medullary thyroid cancer (MTC), and with RET gene-altered advanced tumors or NSCLC/MTC with prior specific RET gene-targeted therapy will be enrolled in Cohorts 1, 2, and 3, respectively, and will receive oral BOS172738 once daily in each 28-day cycle at the recommended Phase 2 dose (RP2D) established in Part A.
  • BOS172738

Eligibility Criteria

        Inclusion Criteria:

        Participants are eligible to be included in the study only if all of the following criteria
        apply:

          -  Male or female participants must be ≥ 18 years, at the time of signing the informed
             consent

          -  Diagnosis of advanced solid tumor with a documented rearranged during transfection
             (RET) gene altered malignancy as determined locally by a DNA based assay of tumor
             tissue and/or blood

          -  Participants must have no alternative approved therapy.

          -  For participants in Part B expansion cohort only: documented local diagnosis of either
             1) advanced RET gene fusion non-small cell lung cancer (NSCLC); 2) advanced RET gene
             mutant medullary thyroid cancer (MTC); or 3) other RET gene altered advanced tumors or
             NSCLC/MTC with prior specific RET gene targeted therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

          -  Negative pregnancy test for females of child bearing potential; must be surgically
             sterile, postmenopausal, or willing and able to be compliant with a contraceptive
             regimen

          -  Contraceptive use by men or women should be consistent with local regulations.

          -  Capable of giving signed informed consent

        Exclusion Criteria:

        Participants are excluded from the study if any of the following criteria apply:

          -  Inability to take oral medications or gastrointestinal (GI) conditions that can
             interfere with the swallowing or absorption of study medication

          -  Uncontrolled or severe concurrent medical condition

          -  History of upper GI bleeding, ulceration, or perforation within 12 months prior to the
             first dose of study drug

          -  Known history of stroke or cerebrovascular accident within 6 months prior to the first
             dose of study drug

          -  Participants with known infection with human immunodeficiency virus (HIV) or Acquired
             Immune Deficiency Syndrome (AIDS) (testing not required)

          -  Participants who are hepatitis B surface antigen positive or participants who are
             hepatitis C antibody positive (Participants who have been successfully treated for
             hepatitis C virus [HCV] are eligible if an undetectable HCV viral load at least 6
             months after completion of treatment can be demonstrated.)

          -  Any evidence of serious active infections

          -  Uncontrolled or severe cardiovascular disease

          -  Uncontrolled intercurrent illness or psychiatric illness/social situations that would
             limit compliance with study requirements

          -  Participants with a prior or concurrent malignancy other than the malignancies under
             study

          -  Ongoing cancer directed therapy
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with any treatment-emergent (TE) serious adverse event (SAE)
Time Frame:a minimum of approximately 3 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:a minimum of approximately 3 months
Safety Issue:
Description:
Measure:Objective Disease Control Rate (ODCR)
Time Frame:a minimum of approximately 3 months
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS)
Time Frame:a minimum of approximately 3 months
Safety Issue:
Description:
Measure:Duration of Response (DoR)
Time Frame:a minimum of approximately 3 months
Safety Issue:
Description:
Measure:Time to Response (TTR)
Time Frame:a minimum of approximately 3 months
Safety Issue:
Description:
Measure:Duration of Complete Response (DoCR)
Time Frame:a minimum of approximately 3 months
Safety Issue:
Description:
Measure:Part A: Plasma concentration of BOS172738
Time Frame:Pre-dose on Days 1, 2, 15, and 16 of Cycle 1; Day 1 of Cycles 2, 3, and 4. 15 minutes (min); 30 min; 1, 3, 6, 8, 10, and 12 hours after the BOS1722722 dose on Days 1 and 15 of Cycle 1 (each cycle is 28 days)
Safety Issue:
Description:
Measure:Part B: Plasma concentration of BOS172738
Time Frame:Pre-dose on Day 1 of Cycles 2, 3, and 4 (each cycle is 28 days)
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Boston Pharmaceuticals

Trial Keywords

  • BOS172738
  • RET gene
  • Medullary Thyroid Cancer
  • Non-Small Cell Lung Cancer

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