HR+/HER2- Breast CancerPhase 1/2AVZO-023-1001NCT06998407
ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors
A Phase 1/2 study testing AVZO-021, Fulvestrant and Letrozole in people with HR+/HER2- Breast Cancer and HR+, HER2-, Advanced Breast Cancer, run by Avenzo Therapeutics, Inc. at 16 sites in United States.
Trial summary
This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-023 in patients with advanced solid tumors. AVZO-023 is an oral medication that inhibits cyclin-dependent kinase 4 (CDK4). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer
- What is being tested?
- AVZO-021, Fulvestrant and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 16 sitesUnited States
- Study dates
- 20 Aug 2025to Aug 2030
- Phase
- Phase 1/2
- 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
- Male or female aged ≥ 18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1 and life expectancy > 3 months
- Patients with histologically or cytologically proven advanced malignancies of preferred indications
- Measurable disease (as assessed by investigator using RECIST v1.1) is preferred in Phase 1 dose escalation, unless otherwise specified in the protocol, and in all patients in Phase 2. Bone only disease is allowed in dose escalation.
- Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable
- Adequate renal, liver, and bone marrow function
Who cannot join
- Patients should not have received any prior selective investigational CDK (CDK2, CDK4, CDK2/4, CDK2/4/6) inhibitors
- Has known active brain metastasis (have either previously untreated intracranial CNS metastasis or previously treated intracranial central nervous system (CNS) metastasis with radiologically documented new or progressing CNS lesions) or leptomeningeal disease
- Other concurrent invasive malignancy or a prior invasive malignancy for which treatment was completed within 3 years before the first dose on study except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or colorectal adenomatous polyps
- Last anticancer treatment within 2 weeks (4 weeks for biologic, immunotherapy or ADC) or 5 half-lives of the drug, whichever is shorter, prior to first dose on study
- Major surgery within 4 weeks prior to first dose on study
- Have received radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of study treatment, except for patients receiving whole brain radiotherapy, which must be completed at least 4 weeks prior to the first dose of study treatment. Patients must have recovered from all radiation-related toxicities, not require corticosteroids, and not have active radiation pneumonitis. Patients who received radiation of >25% of bone marrow are excluded.
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- Strong or moderate CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose on study
- History of serious cardiovascular conditions within 6 months prior to first dose on study
- Unresolved toxicities from prior therapy greater than Grade 1 (per CTCAE version 5.0) (with exceptions of alopecia, vitiligo, and ≤ Grade 2 peripheral neuropathy) prior to the first dose on study
- History of drug-induced pneumonitis/interstitial lung disease
- Confirmed loss of function mutation or deletion of Rb1 gene
- Previous high-dose chemotherapy requiring stem cell rescue
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United States16 sites, 16 recruiting
- Recruiting
Avenzo Therapeutics Recruiting Site
Boston, Massachusetts, 02215
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
Cleveland, Ohio, 44106
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
Columbus, Ohio, 43221
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
Fairfax, Virginia, 22031
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
Fort Worth, Texas, 76104
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
Houston, Texas, 77030
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
Los Angeles, California, 90025
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
Los Angeles, California, 90095
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
Nashville, Tennessee, 37203
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
New Haven, Connecticut, 06519
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
New York, New York, 10016
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
Orlando, Florida, 32827
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
San Antonio, Texas, 78229
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
Sarasota, Florida, 34232
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
Seattle, Washington, 98109
Avenzo Therapeutics
- Recruiting
Avenzo Therapeutics Recruiting Site
Tampa, Florida, 33612
Avenzo Therapeutics
About this study
Official title: A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and/or Endocrine Therapy in Patients With Advanced Solid Tumors
This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-023 in patients with advanced solid tumors. AVZO-023 is an oral medication that inhibits cyclin-dependent kinase 4 (CDK4).
Read the detailed description
AVZO-023 is an oral, potent, and selective inhibitor of CDK4. AVZO-021 is an oral, potent, and selective inhibitor of CDK2 that is currently being investigated in a global Phase 1/2 study in patients with advanced hormone receptive positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (NCT05867251).
In Phase 1, the safety and tolerability of AVZO-023 in patients with HR+/HER2- locally advanced or metastatic breast cancer (mBC) will be assessed. The goal of Phase 1 is to determine the MTD/preliminary RP2D of AVZO-023 for use as monotherapy and in combination with AVZO-021 with or without endocrine therapy (ET).
Phase 2 will assess the antitumor activity and confirm the RP2D of AVZO-023 in combination therapy in patients with HR+/HER2- locally advanced or mBC.
- Being tested
- AVZO-021, Fulvestrant, Letrozole, AVZO-023
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVZO-021Drug
AVZO-021 is an oral selective CDK2 inhibitor
FulvestrantDrug
Also called Faslodex
Antineoplastic agent, estrogen receptor antagonist
LetrozoleDrug
Also called Femara
Antineoplastic agent, aromatase inhibitor
AVZO-023Drug
AVZO-023 is an oral selective CDK4 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Phase 1, monotherapy (Part 1A) and food effect | Experimental | Escalating doses of twice daily, oral AVZO-023 in 28-day cycles, with addition of fulvestrant Receives: Drug: Fulvestrant; Drug: AVZO-023 |
| Phase 1, combination (Parts 1B) | Experimental | Escalating doses of twice daily, oral AVZO-023 in combination with once daily, oral AVZO-021 in 28-day cycles, with addition of fulvestrant Receives: Drug: AVZO-021; Drug: Fulvestrant; Drug: AVZO-023 |
| Phase 1, combination (Parts 1C) | Experimental | Escalating doses of twice daily, oral AVZO-023 in combination with once daily, oral AVZO-021, with once daily, oral letrozole in 28-day cycles Receives: Drug: AVZO-021; Drug: Letrozole; Drug: AVZO-023 |
| Phase 2, combination (Cohorts 2A, 2B, 2C, and 2D) | Experimental | Oral doses of AVZO-023 in 28-day cycles at the RP2D determined in Part 1B/1C, in combination with:
2A) letrozole
2B) fulvestrant
2C) AVZO-021 plus fulvestrant
2D) AVZO-021 plus letrozole Receives: Drug: AVZO-021; Drug: Fulvestrant; Drug: Letrozole; Drug: AVZO-023 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.
Measured: Cycle 1 (28 Days)
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)
Measured: From baseline until end of study treatment or study completion (approximately 2 years)
Determine the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) (Phase 1)
Measured: Approximately 16 months
Objective Response Rate (ORR) (Phase 2)
Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
Measured: From baseline through disease progression or study completion (approximately 2 years)
Secondary outcomes (12)
Objective Response Rate (ORR) (Phase 1)
Measured: From baseline through disease progression or study completion (approximately 2 years)
Duration of response (DOR) (Phase 1 and Phase 2)
Defined as the time from the first confirmed response to radiologic/objective progression.
Measured: From baseline through time to event on study or study completion (approximately 2 years)
Progression Free Survival (PFS) (Phase 1 and Phase 2)
Defined as the time from study drug treatment to death or disease progression, as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
Measured: From baseline through time to event on study or study completion (approximately 2 years)
Overall Survival (OS) (Phase 1 and Phase 2)
Defined as the time from study drug treatment initiation to death from any cause.
Measured: Approximately 76 months
Disease control rate (DCR) (Phase 1 and Phase 2)
Defined as the proportion of patients who achieve tumor relief (CR or PR) and stable disease (SD) after treatment; calculated as the sum of CR, PR, and SD.
Measured: From baseline through disease progression or study completion (approximately 2 years)
Clinical benefit rate (CBR) (Phase 1 and Phase 2)
Defined as the percentage of advanced cancer patients who achieve CR, PR, or at least six months of SD after treatment.
Measured: From baseline through disease progression or study completion (approximately 2 years)
PK Parameters: Maximum plasma concentration (Cmax) (Phase 1)
Measured: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
PK Parameters: Time to maximum plasma concentration (Tmax) (Phase 1)
Measured: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
PK Parameters: Elimination half-life (t1/2) (Phase 1)
Measured: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
PK Parameters: Area under the plasma concentration-time curve from time 0 to last measurable concentration (AUC 0-last) (Phase 1)
Measured: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Determination of RP2D (Phase 2)
Measured: Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 2)
Measured: From baseline until end of study treatment or study completion (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start20 Aug 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Breast 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 dose-escalation Phase 2 dose-expansion
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avenzo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998407
- Sponsor's protocol ID
- AVZO-023-1001
- Acronym
- AVZO-023-1001
- Status last verified
- Feb 2026
- First submitted
- 22 May 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-023 as a Single Agent, and in Combination With AVZO-021 and/or Endocrine Therapy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06998407
- Acronym / sponsor ID
- AVZO-023-1001 / AVZO-023-1001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Avenzo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 31 May 2025 (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.
This study, the first clinical trial of AVZO-023, aims to determine the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-023 in patients with advanced solid tumors. AVZO-023 is an oral medication that inhibits cyclin-dependent kinase 4 (CDK4).
Detailed description
AVZO-023 is an oral, potent, and selective inhibitor of CDK4. AVZO-021 is an oral, potent, and selective inhibitor of CDK2 that is currently being investigated in a global Phase 1/2 study in patients with advanced hormone receptive positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (NCT05867251).
In Phase 1, the safety and tolerability of AVZO-023 in patients with HR+/HER2- locally advanced or metastatic breast cancer (mBC) will be assessed. The goal of Phase 1 is to determine the MTD/preliminary RP2D of AVZO-023 for use as monotherapy and in combination with AVZO-021 with or without endocrine therapy (ET).
Phase 2 will assess the antitumor activity and confirm the RP2D of AVZO-023 in combination therapy in patients with HR+/HER2- locally advanced or mBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Phase 1 dose-escalation Phase 2 dose-expansion
| Arm | Type | Receives |
|---|---|---|
| Phase 1, monotherapy (Part 1A) and food effect | Experimental | Drug: Fulvestrant, Drug: AVZO-023Escalating doses of twice daily, oral AVZO-023 in 28-day cycles, with addition of fulvestrant |
| Phase 1, combination (Parts 1B) | Experimental | Drug: AVZO-021, Drug: Fulvestrant, Drug: AVZO-023Escalating doses of twice daily, oral AVZO-023 in combination with once daily, oral AVZO-021 in 28-day cycles, with addition of fulvestrant |
| Phase 1, combination (Parts 1C) | Experimental | Drug: AVZO-021, Drug: Letrozole, Drug: AVZO-023Escalating doses of twice daily, oral AVZO-023 in combination with once daily, oral AVZO-021, with once daily, oral letrozole in 28-day cycles |
| Phase 2, combination (Cohorts 2A, 2B, 2C, and 2D) | Experimental | Drug: AVZO-021, Drug: Fulvestrant, Drug: Letrozole, Drug: AVZO-023Oral doses of AVZO-023 in 28-day cycles at the RP2D determined in Part 1B/1C, in combination with: 2A) letrozole 2B) fulvestrant 2C) AVZO-021 plus fulvestrant 2D) AVZO-021 plus letrozole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged ≥ 18 years old at screening with Eastern Cooperative Oncology Group (ECOG) 0-1 and life expectancy > 3 months
- Patients with histologically or cytologically proven advanced malignancies of preferred indications
- Measurable disease (as assessed by investigator using RECIST v1.1) is preferred in Phase 1 dose escalation, unless otherwise specified in the protocol, and in all patients in Phase 2. Bone only disease is allowed in dose escalation.
- Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable
- Adequate renal, liver, and bone marrow function
Key exclusion criteria (12 listed)
- Patients should not have received any prior selective investigational CDK (CDK2, CDK4, CDK2/4, CDK2/4/6) inhibitors
- Has known active brain metastasis (have either previously untreated intracranial CNS metastasis or previously treated intracranial central nervous system (CNS) metastasis with radiologically documented new or progressing CNS lesions) or leptomeningeal disease
- Other concurrent invasive malignancy or a prior invasive malignancy for which treatment was completed within 3 years before the first dose on study except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or colorectal adenomatous polyps
- Last anticancer treatment within 2 weeks (4 weeks for biologic, immunotherapy or ADC) or 5 half-lives of the drug, whichever is shorter, prior to first dose on study
- Major surgery within 4 weeks prior to first dose on study
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 |
|---|---|---|
| AVZO-021AVZO-021 is an oral selective CDK2 inhibitor | Drug | Phase 1, combination (Parts 1B), Phase 1, combination (Parts 1C), Phase 2, combination (Cohorts 2A, 2B, 2C, and 2D) |
| FulvestrantAlso: FaslodexAntineoplastic agent, estrogen receptor antagonist | Drug | Phase 1, combination (Parts 1B), Phase 1, monotherapy (Part 1A) and food effect, Phase 2, combination (Cohorts 2A, 2B, 2C, and 2D) |
| LetrozoleAlso: FemaraAntineoplastic agent, aromatase inhibitor | Drug | Phase 1, combination (Parts 1C), Phase 2, combination (Cohorts 2A, 2B, 2C, and 2D) |
| AVZO-023AVZO-023 is an oral selective CDK4 inhibitor | Drug | Phase 1, combination (Parts 1B), Phase 1, combination (Parts 1C), Phase 1, monotherapy (Part 1A) and food effect, Phase 2, combination (Cohorts 2A, 2B, 2C, and 2D) |
Primary outcome
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
Time frame: Cycle 1 (28 Days)
Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)
Time frame: From baseline until end of study treatment or study completion (approximately 2 years)
Determine the Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) (Phase 1)
Time frame: Approximately 16 months
Objective Response Rate (ORR) (Phase 2)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1.
12 secondary outcomes
Objective Response Rate (ORR) (Phase 1)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Duration of response (DOR) (Phase 1 and Phase 2)
Time frame: From baseline through time to event on study or study completion (approximately 2 years)
Progression Free Survival (PFS) (Phase 1 and Phase 2)
Time frame: From baseline through time to event on study or study completion (approximately 2 years)
Overall Survival (OS) (Phase 1 and Phase 2)
Time frame: Approximately 76 months
Disease control rate (DCR) (Phase 1 and Phase 2)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Clinical benefit rate (CBR) (Phase 1 and Phase 2)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
PK Parameters: Maximum plasma concentration (Cmax) (Phase 1)
Time frame: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
PK Parameters: Time to maximum plasma concentration (Tmax) (Phase 1)
Time frame: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
PK Parameters: Elimination half-life (t1/2) (Phase 1)
Time frame: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
PK Parameters: Area under the plasma concentration-time curve from time 0 to last measurable concentration (AUC 0-last) (Phase 1)
Time frame: Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Determination of RP2D (Phase 2)
Time frame: Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 2)
Time frame: From baseline until end of study treatment or study completion (approximately 2 years)
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 10 Aug 2026.
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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.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AVZO-021, Fulvestrant and Letrozole in people with HR+/HER2- Breast Cancer and HR+, HER2-, Advanced Breast Cancer, run by Avenzo Therapeutics, Inc. at 16 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 5 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Medical Information ((858) 239-2944, ClinicalTrials@avenzotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) (time frame: Cycle 1 (28 Days)). The study lists 4 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 10 Aug 2026.