Advanced CancerPhase 1NCT05076552
A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of Oral TACH101 in Participants With Advanced or Metastatic Cancer
A Phase 1 study testing TACH101 in people with Advanced Cancer and Metastatic Solid Tumor, run by Tachyon Therapeutics, Inc. at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Solid Tumor, Solid Tumor
- What is being tested?
- TACH101
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 8 sitesUnited States
- Study dates
- 17 Feb 2023to Jul 2025
- Phase
- 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
- 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.
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- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
- Meets the following laboratory requirements at screening:
- Absolute neutrophil count (ANC) ≥1500/µL, platelet count ≥100,000/µL; and hemoglobin ≥9.0 g/dL.
- Total bilirubin ≤1.5× upper limit of normal (ULN) (Gilbert's syndrome ≤2.5×ULN).
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN.
- 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.
Who cannot join
- 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.
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- Significant cardiovascular disease including any of the following:
- Myocardial infarction within 6 months prior to study entry.
- Uncontrolled angina within 1 month prior to study entry.
- 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%.
- QT interval corrected by the Fridericia correction formula (QTcF) at screening >470 msec for both men and women.
- History of clinically significant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, torsades de pointes).
- History of Mobitz II second degree or third degree heart block.
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
NEXT Oncology
Austin, Texas, 78758
Sarah Cannon Research Institute
Denver, Colorado, 80218
NEXT Oncology
Fairfax, Virginia, 22031
MD Anderson
Houston, Texas, 77030
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
UCI Health
Orange, California, 92868
Sarah Cannon Research Institute
Orlando, Florida, 32827
NEXT Oncology
San Antonio, Texas, 78229
About this study
Official title: 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
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.
- Conditions
- Advanced Cancer, Metastatic Solid Tumor, Solid Tumor
- Being tested
- TACH101
- Keywords
- Cancer, Solid Tumors, Advanced Cancer, TACH101, Metastatic Solid Tumor
- Medical subject headings
- Neoplasm Metastasis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TACH101Drug
Orally via capsules
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Dose Escalation | Experimental | 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. Receives: Drug: TACH101 |
| Phase 1b: Dose Expansion | Experimental | 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). Receives: Drug: TACH101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a Dose Escalation: MTD of TACH101
Measured: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1a Dose Escalation: RP2D of TACH101
Measured: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1b Dose Expansion: ORR
Measured: Day 1 to End of Treatment (up to approximately 201 days)
Secondary outcomes (18)
Phase 1a Dose Escalation: Number of Participants Who Experience Dose-limiting Toxicities (DLTs)
Measured: 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)
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).
Measured: Lead-in Day 1 to End of Treatment (up to approximately 204 days)
Phase 1a Dose Escalation: Area Under the Plasma Concentration-Time Curve (AUC) for TACH101
Measured: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days)
Phase 1a Dose Escalation: Maximum Concentration (Cmax) of TACH101
Measured: 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
Measured: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days)
Phase 1a Dose Escalation: Time to Reach Maximum Concentration (tmax) for TACH101
Measured: 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
Measured: 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
Measured: 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
Measured: Lead-in Day 1 to Cycle 8 Day 1 (cycle = 28 days)
Phase 1a Dose Escalation: ORR
Measured: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1a Dose Escalation: Duration of Response (DOR)
Measured: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1a Dose Escalation: Clinical Benefit Rate (CBR)
Measured: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1b Dose Expansion: Number of Participants With TEAEs
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.
Measured: Lead-in Day 1 to End of Treatment (up to approximately 203 days)
Phase 1b Dose Expansion: Concentration at 2 Hours Postdose (C2h) of TACH101
Measured: Cycle 1 Day 1 to Cycle 10 Day 1 (cycle = 28 days)
Phase 1b Dose Expansion: Cmax of TACH101
Measured: Cycle 1 Day 1 to Cycle 10 Day 1 (cycle = 28 days)
Phase 1b Dose Expansion: Ctrough of TACH101
Measured: Cycle 1 Day 1 to Cycle 10 Day 1 (cycle = 28 days)
Phase 1b Dose Expansion: DOR
Measured: Day 1 to End of Treatment (up to approximately 201 days)
Phase 1b Dose Expansion: CBR
Measured: Day 1 to End of Treatment (up to approximately 201 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start17 Feb 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tachyon Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076552
- Sponsor's protocol ID
- TACH101-CS-0001
- Status last verified
- May 2024
- First submitted
- 30 Sep 2021
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05076552
- Acronym / sponsor ID
- TACH101-CS-0001
- Conditions
- Advanced Cancer, Metastatic Solid Tumor, Solid Tumor
- Keywords
- Cancer, Solid Tumors, Advanced Cancer, TACH101, Metastatic Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tachyon Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 13 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Dose Escalation | Experimental | Drug: TACH101In 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. |
| Phase 1b: Dose Expansion | Experimental | Drug: TACH101In 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TACH101Orally via capsules | Drug | Phase 1a: Dose Escalation, Phase 1b: Dose Expansion |
Primary outcome
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)
18 secondary outcomes
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TACH101 in people with Advanced Cancer and Metastatic Solid Tumor, run by Tachyon Therapeutics, Inc. at 8 sites in United States.
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 14 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Phase 1a Dose Escalation: MTD of TACH101 (time frame: Day 1 to End of Treatment (up to approximately 201 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2024.