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A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral TACH101 in Participants With Advanced or Metastatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05076552
Recruitment Status : Recruiting
First Posted : October 13, 2021
Last Update Posted : May 23, 2024
Sponsor:
Information provided by (Responsible Party):
Tachyon Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE September 30, 2021
First Posted Date  ICMJE October 13, 2021
Last Update Posted Date May 23, 2024
Actual Study Start Date  ICMJE February 17, 2023
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2024)
  • Phase 1a Dose Escalation: MTD of TACH101 [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1a Dose Escalation: RP2D of TACH101 [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1b Dose Expansion: ORR [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2021)
  • Phase 1 Dose Escalation: Maximum Tolerated Dose (MTD) of TACH101 [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1 Dose Escalation: Recommended Phase 2 Dose (RP2D) of TACH101 [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1b Dose Expansion: Objective Response Rate (ORR) [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2024)
  • Phase 1a Dose Escalation: Number of Participants Who Experience Dose-limiting Toxicities (DLTs) [ Time Frame: Cycle 1 Day 1 up to Cycle 1 Day 28 (cycle length = 28 days) ]
  • Phase 1a Dose Escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Lead-in Day 1 to End of Treatment (up to approximately 204 days) ]
    A TEAE is defined as any untoward medical occurrence in participants that happened after study drug administration. Any clinically significant abnormalities in vital signs, clinical laboratory tests, or electrocardiograms (ECGs) will be recorded as adverse events (AEs).
  • Phase 1a Dose Escalation: Area Under the Plasma Concentration-Time Curve (AUC) for TACH101 [ Time Frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days) ]
  • Phase 1a Dose Escalation: Maximum Concentration (Cmax) of TACH101 [ Time Frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days) ]
  • Phase 1a Dose Escalation: Observed Predose Plasma Concentration During Multiple Dosing (Ctrough) of TACH101 [ Time Frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days) ]
  • Phase 1a Dose Escalation: Time to Reach Maximum Concentration (tmax) for TACH101 [ Time Frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days) ]
  • Phase 1a Dose Escalation: Apparent Terminal Elimination Half-life (t1/2) of TACH101 [ Time Frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days) ]
  • Phase 1a Dose Escalation: Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of TACH101 [ Time Frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days) ]
  • Phase 1a Dose Escalation: Apparent Clearance After Extravascular Administration (CL/F) of TACH101 [ Time Frame: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days) ]
  • Phase 1a Dose Escalation: ORR [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1a Dose Escalation: Duration of Response (DOR) [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1a Dose Escalation: Clinical Benefit Rate (CBR) [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1b Dose Expansion: Number of Participants With TEAEs [ Time Frame: Lead-in Day 1 to End of Treatment (up to approximately 203 days) ]
    A TEAE is defined as any untoward medical occurrence in participants that happened after study drug administration. Any clinically significant abnormalities in vital signs, clinical laboratory tests, or ECGs will be recorded as AEs.
  • Phase 1b Dose Expansion: Concentration at 2 Hours Postdose (C2h) of TACH101 [ Time Frame: Cycle 1 Day 1 to Cycle 10 Day 1 (cycle = 28 days) ]
  • Phase 1b Dose Expansion: Cmax of TACH101 [ Time Frame: Cycle 1 Day 1 to Cycle 10 Day 1 (cycle = 28 days) ]
  • Phase 1b Dose Expansion: Ctrough of TACH101 [ Time Frame: Cycle 1 Day 1 to Cycle 10 Day 1 (cycle = 28 days) ]
  • Phase 1b Dose Expansion: DOR [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1b Dose Expansion: CBR [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2021)
  • Phase 1 Dose Escalation: Number of Participants Who Experience Dose-limiting Toxicities (DLTs) [ Time Frame: Cycle 1 Day 1 up to Cycle 1 Day 28 (cycle length = 28 days) ]
  • Phase 1 Dose Escalation: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Lead-in Day 1 to End of Treatment (up to approximately 203 days) ]
    A TEAE is defined as any untoward medical occurrence in participants that happened after study drug administration. Any clinically significant abnormalities in vital signs, clinical laboratory tests, or electrocardiograms (ECGs) will be recorded as AEs.
  • Phase 1 Dose Escalation: Area Under the Plasma Concentration-Time Curve (AUC) for TACH101 [ Time Frame: Lead-in Day 1 to Cycle 4 Day 1 (cycle = 28 days) ]
  • Phase 1 Dose Escalation: Maximum Concentration (Cmax) of TACH101 [ Time Frame: Lead-in Day 1 to Cycle 4 Day 1 (cycle = 28 days) ]
  • Phase 1 Dose Escalation: Observed Predose Plasma Concentration During Multiple Dosing (Ctrough) of TACH101 [ Time Frame: Lead-in Day 1 to Cycle 4 Day 1 (cycle = 28 days) ]
  • Phase 1 Dose Escalation: Time to Reach Maximum Concentration (tmax) for TACH101 [ Time Frame: Lead-in Day 1 to Cycle 4 Day 1 (cycle = 28 days) ]
  • Phase 1 Dose Escalation: Apparent Terminal Elimination Half-life (t1/2) of TACH101 [ Time Frame: Lead-in Day 1 to Cycle 4 Day 1 (cycle = 28 days) ]
  • Phase 1 Dose Escalation: Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of TACH101 [ Time Frame: Lead-in Day 1 to Cycle 4 Day 1 (cycle = 28 days) ]
  • Phase 1 Dose Escalation: Apparent Clearance After Extravascular Administration (CL/F) of TACH101 [ Time Frame: Lead-in Day 1 to Cycle 4 Day 1 (cycle = 28 days) ]
  • Phase 1 Dose Escalation: Objective Response Rate (ORR) [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1 Dose Escalation: Duration of Response (DOR) [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1 Dose Escalation: Clinical Benefit Rate (CBR) [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1b Dose Expansion: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Lead-in Day 1 to End of Treatment (up to approximately 203 days) ]
    A TEAE is defined as any untoward medical occurrence in participants that happened after study drug administration. Any clinically significant abnormalities in vital signs, clinical laboratory tests, or electrocardiograms (ECGs) will be recorded as AEs.
  • Phase 1b Dose Expansion: Concentration at 2 Hours Postdose (C2h) of TACH101 [ Time Frame: Cycle 1 Day 1 to Cycle 6 Day 1 (cycle = 28 days) ]
  • Phase 1b Dose Expansion: Maximum Concentration (Cmax) of TACH101 [ Time Frame: Cycle 1 Day 1 to Cycle 6 Day 1 (cycle = 28 days) ]
  • Phase 1b Dose Expansion: Observed Predose Plasma Concentration During Multiple Dosing (Ctrough) of TACH101 [ Time Frame: Cycle 1 Day 1 to Cycle 6 Day 1 (cycle = 28 days) ]
  • Phase 1b Dose Expansion: Duration of Response (DOR) [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1b Dose Expansion: Clinical Benefit Rate (CBR) [ Time Frame: Day 1 to End of Treatment (up to approximately 201 days) ]
  • Phase 1b Dose Expansion: Plasma Concentration of TACH101 [ Time Frame: Cycle 1 Day 1 to Cycle 6 Day 1 (cycle = 28 days) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral TACH101 in Participants With Advanced or Metastatic Cancer
Official Title  ICMJE A Phase 1a/1b Open-label Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral TACH101 in Patients With Advanced or Metastatic Solid Tumors
Brief Summary The main objective for part 1a of the study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) and to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of oral TACH101 in participants with advanced and metastatic solid tumors. For part 1b, the main objective is the objective response rate (ORR) as assessed by radiographic progression measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Cancer
  • Metastatic Solid Tumor
  • Solid Tumor
Intervention  ICMJE Drug: TACH101
Orally via capsules
Study Arms  ICMJE
  • Experimental: Phase 1a: Dose Escalation
    In Phase 1a, participants will receive TACH101 in a 48 hour lead in period followed by repeated dosing at different dosing regimens in each 28 day cycle.
    Intervention: Drug: TACH101
  • Experimental: Phase 1b: Dose Expansion

    In Phase 1b, participants will receive TACH101 at the RP2D identified in Phase 1a. Two cohorts of participants will be enrolled:

    • Participants with gastrointestinal cancers.
    • Participants with high microsatellite instability (MSI-H) metastatic colorectal cancer (CRC).
    Intervention: Drug: TACH101
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 30, 2021)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the participant or legally authorized representative prior to any study-related procedures being performed.
  • 18 years of age or older.
  • Phase 1a: Participant must have advanced or metastatic solid tumor that has progressed or was non-responsive or intolerant to available therapies and for which no standard or available curative therapy exists, or, in the opinion of the investigator, is not a candidate for, or would be unlikely to tolerate or derive significant clinical benefit from, appropriate standard of care therapy.
  • Phase 1b: Participants must have advanced or metastatic gastrointestinal tumors, or high microsatellite instability colorectal cancer (MSI-H CRC) that has progressed or was non-responsive or intolerant to standard therapy (e.g., fluoropyrimidine and oxaliplatin with or without bevacizumab), or, in the opinion of the investigator, is not a candidate for, or would be unlikely to tolerate or derive significant clinical benefit from, appropriate standard of care therapy. Participants with potentially curative therapy will not be enrolled (e.g., participants with CRC and oligometastatic disease who are candidates for resection). Participants with MSI-H CRC must have received a prior line of therapy with a checkpoint inhibitor. Note: For both Phase 1a and 1b, if a participant has available therapies but is determined to be ineligible by the investigator due to being unlikely to tolerate or benefit from available therapies, the reason for this must be documented in the medical record and case report form.
  • Presence of advanced or metastatic disease that is measurable according to RECIST v 1.1.
  • The participant must have recovered from toxicities related to any prior treatments (Grade ≤1) except alopecia, anorexia, or toxicity that is stable and poses no significant risk to the participant. Grade 2 peripheral neuropathy after documented treatment with taxanes and/or platinum-based therapy is allowed.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
  • Meets the following laboratory requirements at screening:

    1. Absolute neutrophil count (ANC) ≥1500/µL, platelet count ≥100,000/µL; and hemoglobin ≥9.0 g/dL.
    2. Total bilirubin ≤1.5× upper limit of normal (ULN) (Gilbert's syndrome ≤2.5×ULN).
    3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN.
    4. Creatinine clearance (CrCl) >60 mL/min by the Cockcroft-Gault formula: CrCl={([l 40-age (years)]×weight [kg])/(72× serum creatinine [mg/dL])}(×0.85 for females).
  • Women of childbearing potential (WOCBP) must have a negative pregnancy test during the screening period before beginning treatment.
  • WOCBP or men whose partner is a WOCBP agrees to use contraception while participating in this study, and for a minimum of 3 months for men and 6 months for women following the last dose of study treatment.

Exclusion Criteria:

Participants will be excluded from participation in the study if any of the following apply:

  • Participants who have received allogenic hematologic stem cell transplant.
  • Major surgery within 2 months prior to screening.
  • Prior history of or concurrent secondary primary malignancy whose natural history or treatment has the potential to interfere with the safety and/or efficacy assessment of TACH101.
  • Prior gastrectomy or upper bowel removal or any other gastrointestinal disorder that would interfere with the absorption or excretion of TACH101.
  • Known or suspected brain metastases.
  • Significant cardiovascular disease including any of the following:

    1. Myocardial infarction within 6 months prior to study entry.
    2. Uncontrolled angina within 1 month prior to study entry.
    3. Congestive heart failure New York Heart Association (NYHA) class III or IV, or a history of congestive heart failure NYHA class III or IV unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 3 months prior to study entry results in a left ventricular ejection fraction (LVEF) ≥45%.
    4. QT interval corrected by the Fridericia correction formula (QTcF) at screening >470 msec for both men and women.
    5. History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes).
    6. History of Mobitz II second degree or third degree heart block.
    7. Uncontrolled hypertension as indicated by a resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg at screening.
  • Acute or chronic liver or kidney disease.
  • Concurrent disease or any clinically significant abnormality following the investigator's review of the screening physical examination findings, 12-lead electrocardiogram (ECG) results, and clinical laboratory tests, which in the judgment of the investigator would interfere with the participant's participation in this study or evaluation of study results.
  • Known or suspected hypersensitivity to any components of the formulation used for TACH101.
  • Any ongoing anticancer therapy including; small molecules, immunotherapy, chemotherapy, monoclonal antibodies, or any other experimental drug. Prior therapy must be stopped at least 4 weeks or 5 half-lives (whichever is shorter) before first dose.
  • Clinically significant active viral, bacterial or fungal infection requiring: Intravenous treatment with antimicrobial therapy completed less than 2 weeks prior to first dose, or oral treatment with antimicrobial therapy completed less than one week prior to first dose.
  • Known history of infection with human immunodeficiency virus (HIV) hepatitis B, or hepatitis C.
  • For Phase 1b, prior participation in Phase 1a.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tachyon Therapeutics 832-952-0829 TACH101study@tachyontx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05076552
Other Study ID Numbers  ICMJE TACH101-CS-0001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Tachyon Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Tachyon Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tachyon Therapeutics, Inc.
Verification Date May 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP