Adenoid Cystic CarcinomaPhase 1NCT06462183
Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
A Phase 1 study testing RGT-61159 and lenvatinib in people with Adenoid Cystic Carcinoma and Colorectal Cancer, run by Rgenta Therapeutics Inc at 9 sites in 2 countries.
Trial summary
Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenoid Cystic Carcinoma, Colorectal Cancer
- What is being tested?
- RGT-61159 and lenvatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 19 Aug 2024to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Histologically confirmed ACC or CRC
- Radiographically measurable disease as assessed per RECIST 1.1, with at least 1 site of disease that is measurable and that has not been previously irradiated; or, if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
- Patients with locally relapsed/refractory (R/R) advanced or metastatic ACC not amenable to potentially curative surgery or radiotherapy and progression of disease within 12 months at study entry
- Patients with CRC must have locally R/R advanced or metastatic disease not amenable to potentially curative surgery or radiotherapy; must have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidines-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and if RAS wild-type, an anti-EGFR therapy.
- Adequate hematologic status, organ function, renal function, liver function and prothrombin time (PT) or INR ≤ 1.5 × ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
- Resolved acute effects of any prior therapy to baseline
- Patients with ACC must have documented evidence of intact MYB pseudoexon positive criteria or be MYB wild type and patients with CRC must have amplification of MYB as determined by designated assay
Who cannot join
- Major surgery or significant traumatic injury within 28 days prior to Cycle 1 Day 1
- Chemotherapy within 14 days prior to Cycle 1 Day 1
- Use of nitrosoureas or mitomycin C within 6 weeks prior to Cycle 1 Day 1
- Radiation therapy within 21 days prior to Cycle 1 Day 1
- Investigational drug use, targeted therapy, or biologic therapy within 28 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1
- Ongoing systemic infection requiring treatment with antibiotic, antiviral, or antifungal treatment
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- Active known second malignancy
- Clinically significant cardiac disease
- Infection with human immunodeficiency virus (HIV)-1 or HIV-2 unless it's well-controlled HIV (eg, cluster of differentiation 4 [CD4] > 350/mm3 and undetectable viral load)
- Current active liver disease including hepatitis A (hepatitis A [HepA] virus immunoglobulin M [IgM] positive), hepatitis B (hepatitis B virus [HBV] surface antigen positive), or hepatitis C (hepatitis C virus [HCV] antibody positive, confirmed by HCV RNA)
- Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant small bowel resection that would preclude adequate absorption
- Uncontrolled diabetes
- Treatment with a long-acting hematopoietic growth factor within 14 days before Cycle 1 Day 1 or a short-acting hematopoietic growth factor within 7 days before Cycle 1 Day 1
- Treatment with high-dose chemotherapy and stem-cell rescue (autologous stem cell transplant) or allogeneic stem cell transplant within 90 days before Cycle 1 Day 1
- Patients with central nervous system (CNS) metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroid throughout this indication for at least 4 weeks before starting treatment in this study
- History of solid organ transplantation
- Coronavirus disease 2019 (COVID-19) vaccination within 14 days prior to first dose of study drug
- Prior treatment with a MYB inhibitor
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
University of Michigan
Ann Arbor, Michigan, 48109
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Next Oncology VA
Fairfax, Virginia, 22031
MD Anderson Cancer Center
Houston, Texas, 77030
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Canada2 sites
Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
About this study
Official title: A Phase 1a/1b, First-in-human, Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC
Read the detailed description
This first-in-human, Phase 1, multi-center, open-label, non-randomized study, is designed to evaluate safety, tolerability, and anti-tumor activity of once-daily RGT-61159 in patients with advanced R/R ACC or R/R CRC for whom standard therapy with proven clinical benefit does not exist, is no longer effective, or is not appropriate. RGT-61159 is an oral, small molecule MYB inhibitor.
- Conditions
- Adenoid Cystic Carcinoma, Colorectal Cancer
- Being tested
- RGT-61159, lenvatinib
- Medical subject headings
- Carcinoma, Adenoid Cystic, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGT-61159Drug
Oral MYB inhibitor
lenvatinibDrug
oral approved multi kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation monotherapy continuous dosing | Experimental | RGT-61159 monotherapy in escalating doses Receives: Drug: RGT-61159 |
| Dose expansion Cohort A monotherapy continuous dosing | Experimental | Dose optimization; RGT-61159 monotherapy, 2 doses, randomized allocation Receives: Drug: RGT-61159 |
| Dose expansion Cohort B monotherapy continuous dosing | Experimental | Simon's 2 stage, RGT-61150 monotherapy at optimized dose from Part A Receives: Drug: RGT-61159 |
| Dose escalation RGT-61159 continuous dosing + lenvatanib | Experimental | RGT-61159 in escalating doses + lenvatanib Receives: Drug: RGT-61159; Drug: lenvatinib |
| Dose expansion RGT-61159 continuous dosing + lenvatinib | Experimental | Not described Receives: Drug: RGT-61159; Drug: lenvatinib |
| Dose escalation RGT-61159 monotherapy intermittent dosing | Experimental | Not described Receives: Drug: RGT-61159 |
| Dose escalation RGT-61159 intermittent dosing + lenvatinib | Experimental | Not described Receives: Drug: RGT-61159; Drug: lenvatinib |
| Dose expansion RGT-61159 monotherapy intermittant dosing | Experimental | Not described Receives: Drug: RGT-61159 |
| Dose expansion RGT-61159 intermittent dosing + lenvatinib | Experimental | Not described Receives: Drug: RGT-61159; Drug: lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of dose-limiting toxicities (DLTs) in first cycle of administration
Measured: 21 days
Number and type of adverse events
Measured: Through study completion, estimated as 30 days after last dose of study drug
Recommended Phase 2 Dose (RP2D)
Measured: Assessed at the end of Cycle 1 for each subject (each cycle 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start19 Aug 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid Cystic CarcinomaStudies 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
- Single group
- Model description
- Open-label, ascending dose escalation followed by dose expansion
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rgenta Therapeutics Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462183
- Sponsor's protocol ID
- RGT61159-01
- Status last verified
- Sep 2026
- First submitted
- 7 Jun 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b, First-in-human, Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)
- ClinicalTrials.gov ID
- NCT06462183
- Acronym / sponsor ID
- RGT61159-01
- Conditions
- Adenoid Cystic Carcinoma, Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Rgenta Therapeutics IncIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jun 2024 (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.
Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC
Detailed description
This first-in-human, Phase 1, multi-center, open-label, non-randomized study, is designed to evaluate safety, tolerability, and anti-tumor activity of once-daily RGT-61159 in patients with advanced R/R ACC or R/R CRC for whom standard therapy with proven clinical benefit does not exist, is no longer effective, or is not appropriate. RGT-61159 is an oral, small molecule MYB inhibitor.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 9
- Model description
- Open-label, ascending dose escalation followed by dose expansion
| Arm | Type | Receives |
|---|---|---|
| Dose escalation monotherapy continuous dosing | Experimental | Drug: RGT-61159RGT-61159 monotherapy in escalating doses |
| Dose expansion Cohort A monotherapy continuous dosing | Experimental | Drug: RGT-61159Dose optimization; RGT-61159 monotherapy, 2 doses, randomized allocation |
| Dose expansion Cohort B monotherapy continuous dosing | Experimental | Drug: RGT-61159Simon's 2 stage, RGT-61150 monotherapy at optimized dose from Part A |
| Dose escalation RGT-61159 continuous dosing + lenvatanib | Experimental | Drug: RGT-61159, Drug: lenvatinibRGT-61159 in escalating doses + lenvatanib |
| Dose expansion RGT-61159 continuous dosing + lenvatinib | Experimental | Drug: RGT-61159, Drug: lenvatinib |
| Dose escalation RGT-61159 monotherapy intermittent dosing | Experimental | Drug: RGT-61159 |
| Dose escalation RGT-61159 intermittent dosing + lenvatinib | Experimental | Drug: RGT-61159, Drug: lenvatinib |
| Dose expansion RGT-61159 monotherapy intermittant dosing | Experimental | Drug: RGT-61159 |
| Dose expansion RGT-61159 intermittent dosing + lenvatinib | Experimental | Drug: RGT-61159, Drug: lenvatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed ACC or CRC
- Radiographically measurable disease as assessed per RECIST 1.1, with at least 1 site of disease that is measurable and that has not been previously irradiated; or, if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation
- Patients with locally relapsed/refractory (R/R) advanced or metastatic ACC not amenable to potentially curative surgery or radiotherapy and progression of disease within 12 months at study entry
- Patients with CRC must have locally R/R advanced or metastatic disease not amenable to potentially curative surgery or radiotherapy; must have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidines-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and if RAS wild-type, an anti-EGFR therapy.
- Adequate hematologic status, organ function, renal function, liver function and prothrombin time (PT) or INR ≤ 1.5 × ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
Key exclusion criteria (18 listed)
- Major surgery or significant traumatic injury within 28 days prior to Cycle 1 Day 1
- Chemotherapy within 14 days prior to Cycle 1 Day 1
- Use of nitrosoureas or mitomycin C within 6 weeks prior to Cycle 1 Day 1
- Radiation therapy within 21 days prior to Cycle 1 Day 1
- Investigational drug use, targeted therapy, or biologic therapy within 28 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1
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 |
|---|---|---|
| RGT-61159Oral MYB inhibitor | Drug | Dose escalation RGT-61159 continuous dosing + lenvatanib, Dose escalation RGT-61159 intermittent dosing + lenvatinib, Dose escalation RGT-61159 monotherapy intermittent dosing, Dose escalation monotherapy continuous dosing, Dose expansion Cohort A monotherapy continuous dosing, Dose expansion Cohort B monotherapy continuous dosing, Dose expansion RGT-61159 continuous dosing + lenvatinib, Dose expansion RGT-61159 intermittent dosing + lenvatinib, Dose expansion RGT-61159 monotherapy intermittant dosing |
| lenvatiniboral approved multi kinase inhibitor | Drug | Dose escalation RGT-61159 continuous dosing + lenvatanib, Dose escalation RGT-61159 intermittent dosing + lenvatinib, Dose expansion RGT-61159 continuous dosing + lenvatinib, Dose expansion RGT-61159 intermittent dosing + lenvatinib |
Primary outcome
Number and type of dose-limiting toxicities (DLTs) in first cycle of administration
Time frame: 21 days
Number and type of adverse events
Time frame: Through study completion, estimated as 30 days after last dose of study drug
Recommended Phase 2 Dose (RP2D)
Time frame: Assessed at the end of Cycle 1 for each subject (each cycle 21 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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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.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RGT-61159 and lenvatinib in people with Adenoid Cystic Carcinoma and Colorectal Cancer, run by Rgenta Therapeutics Inc at 9 sites in 2 countries.
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 7 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number and type of dose-limiting toxicities (DLTs) in first cycle of administration (time frame: 21 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 17 Sep 2026.