Advanced or Metastatic ER+ HER2- Breast Cancer (mBC)Phase 1NCT06784193
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
A Phase 1 study testing OP-3136, Fulvestrant and Palazestrant in people with Advanced or Metastatic ER+ HER2- Breast Cancer (mBC) and Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), run by Olema Pharmaceuticals, Inc. at 25 sites in 6 countries.
Trial summary
This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, as monotherapy and in combination with other anticancer agents in participants… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic ER+ HER2- Breast Cancer (mBC), Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- What is being tested?
- OP-3136, Fulvestrant and Palazestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 25 sitesin 6 countries
- Study dates
- 16 Dec 2024to 30 Aug 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
- Participants with advanced or metastatic ER+HER2- breast cancer, mCRPC, or NSCLC (Part 1) or advanced or metastatic ER+HER2- BC or mCRPC (Part 2).
- Part 1A (Dose escalation for OP-3136 monotherapy): Participants must have a tumor that is unresectable or metastatic and for which life prolonging measures do not exist or available therapies are intolerable or no longer effective.
- Part 1B (Dose escalation for OP-3136 in combination with fulvestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting.
- Part 1C (Dose escalation for OP-3136 in combination with palazestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting.
- Part 2A (Dose Expansion in ER+ HER2- mBC for OP-3136 monotherapy): Participants must have received up to 3 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and up to 1 prior line of chemotherapy or an antibody-drug conjugate.
- Part 2A (Dose Expansion in mCRPC for OP-3136 monotherapy): Participants must have received up to 4 lines of prior systemic therapy for prostate cancer. Prior therapy must include treatment with an androgen receptor pathway inhibitor(s).
- Part 2B (Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with fulvestrant OR Dose Expansion in ER+ HER2- mBC for OP-3136 in combination with palazestrant): Participants must have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting. Participants must have received no more than 2 prior lines of endocrine therapy in the advanced or metastatic setting and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting.
Who cannot join
- Prior therapy with KAT6A/B inhibitor in any treatment setting.
- Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term.
- Known active or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require CNS-specific treatment, or participants who did not demonstrate clinical and radiologic stability during the last 2 months prior to the first dose of study treatment or require or are currently on steroid therapy for CNS metastases.
- History of cerebral vascular disease, including transient ischemic attack, within 6 months prior to the first dose of study treatment.
- History of or ongoing impaired cardiac function or clinically significant cardiac disease within 6 months prior to the first dose of study treatment.
- Note: Additional inclusion/exclusion criteria may apply.
Trial locations and contacts
25 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
There may be multiple sites in this clinical trial Olema Clinical Trial Lead contact
Olema Medical Study Director contact
25 sites in 6 countries
United States13 sites, 12 recruiting
- Recruiting
University of Colorado
Aurora, Colorado, 80045
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
The Ohio State University
Columbus, Ohio, 43021
- Recruiting
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
- Recruiting
START - Midwest
Grand Rapids, Michigan, 49546
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
- Terminated
University Medical Center - New Orleans
New Orleans, Louisiana, 70112
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
START - San Antonio
San Antonio, Texas, 78229
- Recruiting
Florida Cancer Specialists
Sarasota, Florida, 34232
- Recruiting
START - Mountain Region
West Valley City, Utah, 84119
Australia4 sites, 4 recruiting
- Recruiting
Cancer Research South Australia
Adelaide, South Australia, 5000
- Recruiting
The Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010
- Recruiting
Liverpool Hospital
Liverpool, New South Wales, 2170
- Recruiting
Macquarie University Clinical Trials Unit
Macquarie, New South Wales, 2109
France3 sites, 3 recruiting
- Recruiting
Hôpital Paris Saint-Joseph
Paris, Paris, 75014
- Recruiting
Institut De Cancerologie De L'ouest
Saint-Herblain, Loire-Atlantique, 44805
- Recruiting
Institut Gustave Roussy
Villejuif, Val-de-Marne, 94800
Spain3 sites, 3 recruiting
- Recruiting
START - Barcelona
Barcelona, Barcelona, 08023
- Recruiting
Start - Fjd
Madrid, Madrid, 28040
- Recruiting
START Madrid - CIOCC
Madrid, Madrid, 28050
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong, Hong Kong
About this study
Official title: A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors
This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, as monotherapy and in combination with other anticancer agents in participants with advanced solid tumors.
This study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part (Part 2).
Read the detailed description
Part 1A (Dose Escalation for OP-3136 Monotherapy): This part of the study will evaluate the safety, tolerability, and PK in a range of doses of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, administered orally once daily to participants with ER+ HER2- advanced or metastatic breast cancer (mBC), advanced or metastatic castration resistant prostate cancer (mCRPC), or advanced or metastatic non-small cell lung cancer (mNSCLC), and determine the maximum tolerated dose (MTD) and the recommended dose/regimen for expansion (RDE).
Part 1B (Dose Escalation for OP-3136 in Combination with Fulvestrant): This part of the study will evaluate the safety and PK of OP-3136 administered in combination with fulvestrant in participants with ER+ HER2- mBC, and determine MTD and RDE for this combination.
Part 1C (Dose Escalation for OP-3136 in Combination with Palazestrant): This part of the study will evaluate the safety and PK of OP-3136 administered in combination with palazestrant in participants with ER+ HER2- mBC, and determine MTD and RDE for this combination.
Part 2A (Dose Expansion for OP-3136 Monotherapy): This part will evaluate two expansion cohorts at the monotherapy RDE from part 1 in participants with ER+ HER2- mBC and participants with mCRPC.
Part 2B (Dose Expansion for OP-3136 in Combination with Fulvestrant OR Palazestrant): This part will evaluate the RDEs for OP-3136 in combination with fulvestrant from Part 1B OR the RDEs of OP-3136 in combination with palazestrant in an expansion cohort in participants with ER+ HER2- mBC.
- Conditions
- Advanced or Metastatic ER+ HER2- Breast Cancer (mBC), Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC), Metastatic Breast Cancer, Fulvestrant, Palazestrant
- Being tested
- OP-3136, Fulvestrant, Palazestrant
- Keywords
- KAT6 Inhibitor, Histone Acetyltransferase (HAT) Inhibitor, Epigenetic
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OP-3136Drug
Selective inhibitor of HAT enzymes KAT6A and KAT6B
FulvestrantDrug
Selective estrogen receptor degrader (SERD)
PalazestrantDrug
Complete estrogen receptor antagonist (CERAN)
| Study group | Role | What they receive |
|---|---|---|
| Part 1A Dose Escalation monotherapy | Experimental | Not described Receives: Drug: OP-3136 |
| Part 1B Dose Escalation in combination with fulvestrant | Experimental | Not described Receives: Drug: OP-3136; Drug: Fulvestrant |
| Part 1C Dose Escalation in combination with palazestrant | Experimental | Not described Receives: Drug: OP-3136; Drug: Palazestrant |
| Part 2A Dose Expansion monotherapy - mBC | Experimental | Not described Receives: Drug: OP-3136 |
| Part 2A Dose Expansion monotherapy - mCRPC | Experimental | Not described Receives: Drug: OP-3136 |
| Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1 | Experimental | Not described Receives: Drug: OP-3136; Drug: Fulvestrant; Drug: Palazestrant |
| Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2 | Experimental | Not described Receives: Drug: OP-3136; Drug: Fulvestrant; Drug: Palazestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose-limiting toxicities in the Dose Escalation Arms
Measured: Up to 28 days
Incidence of adverse events and laboratory abnormalities
Measured: Up to 26 months
Secondary outcomes (6)
Maximum observed concentration (Cmax)
Measured: Up to 26 months
Time to maximum concentration (Tmax)
Measured: Up to 26 months
Area under the curve from time zero to 24 hours (AUC0-24)
Measured: Up to 26 months
Overall Response Rate (ORR)
Measured: Up to 26 months
Duration of Response (DOR)
Measured: Up to 26 months
Clinical Benefit Rate (CBR)
Measured: Up to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start16 Dec 2024
- Primary completion30 May 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic ER+ HER2- Breast Cancer (mBC)Studies 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olema Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06784193
- Sponsor's protocol ID
- OP-3136-101
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-in-Human, Open-Label, Multicenter Study of OP-3136 in Adult Participants With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT06784193
- Acronym / sponsor ID
- OP-3136-101
- Conditions
- Advanced or Metastatic ER+ HER2- Breast Cancer (mBC), Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC), Metastatic Breast Cancer, Fulvestrant, Palazestrant
- Keywords
- KAT6 Inhibitor, Histone Acetyltransferase (HAT) Inhibitor, Epigenetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Olema Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 20 Jan 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 is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, as monotherapy and in combination with other anticancer agents in participants with advanced solid tumors.
This study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part (Part 2).
Detailed description
Part 1A (Dose Escalation for OP-3136 Monotherapy): This part of the study will evaluate the safety, tolerability, and PK in a range of doses of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, administered orally once daily to participants with ER+ HER2- advanced or metastatic breast cancer (mBC), advanced or metastatic castration resistant prostate cancer (mCRPC), or advanced or metastatic non-small cell lung cancer (mNSCLC), and determine the maximum tolerated dose (MTD) and the recommended dose/regimen for expansion (RDE).
Part 1B (Dose Escalation for OP-3136 in Combination with Fulvestrant): This part of the study will evaluate the safety and PK of OP-3136 administered in combination with fulvestrant in participants with ER+ HER2- mBC, and determine MTD and RDE for this combination.
Part 1C (Dose Escalation for OP-3136 in Combination with Palazestrant): This part of the study will evaluate the safety and PK of OP-3136 administered in combination with palazestrant in participants with ER+ HER2- mBC, and determine MTD and RDE for this combination.
Part 2A (Dose Expansion for OP-3136 Monotherapy): This part will evaluate two expansion cohorts at the monotherapy RDE from part 1 in participants with ER+ HER2- mBC and participants with mCRPC.
Part 2B (Dose Expansion for OP-3136 in Combination with Fulvestrant OR Palazestrant): This part will evaluate the RDEs for OP-3136 in combination with fulvestrant from Part 1B OR the RDEs of OP-3136 in combination with palazestrant in an expansion cohort in participants with ER+ HER2- mBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1A Dose Escalation monotherapy | Experimental | Drug: OP-3136 |
| Part 1B Dose Escalation in combination with fulvestrant | Experimental | Drug: OP-3136, Drug: Fulvestrant |
| Part 1C Dose Escalation in combination with palazestrant | Experimental | Drug: OP-3136, Drug: Palazestrant |
| Part 2A Dose Expansion monotherapy - mBC | Experimental | Drug: OP-3136 |
| Part 2A Dose Expansion monotherapy - mCRPC | Experimental | Drug: OP-3136 |
| Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1 | Experimental | Drug: OP-3136, Drug: Fulvestrant, Drug: Palazestrant |
| Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2 | Experimental | Drug: OP-3136, Drug: Fulvestrant, Drug: Palazestrant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants with advanced or metastatic ER+HER2- breast cancer, mCRPC, or NSCLC (Part 1) or advanced or metastatic ER+HER2- BC or mCRPC (Part 2).
- Part 1A (Dose escalation for OP-3136 monotherapy): Participants must have a tumor that is unresectable or metastatic and for which life prolonging measures do not exist or available therapies are intolerable or no longer effective.
- Part 1B (Dose escalation for OP-3136 in combination with fulvestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting.
- Part 1C (Dose escalation for OP-3136 in combination with palazestrant): Participants with advanced or metastatic ER+ HER2- breast cancer that have progressed on or after at least 1 prior line of treatment that included endocrine therapy and CDK 4/6 inhibitor in advanced or metastatic setting and must have received no more than 2 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and no more than 1 prior line of chemotherapy or an antibody-drug conjugate in the advanced or metastatic setting.
- Part 2A (Dose Expansion in ER+ HER2- mBC for OP-3136 monotherapy): Participants must have received up to 3 prior lines of endocrine therapy (one of which must be in combination with CDK4/6 inhibitor) and up to 1 prior line of chemotherapy or an antibody-drug conjugate.
Key exclusion criteria (6 listed)
- Prior therapy with KAT6A/B inhibitor in any treatment setting.
- Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term.
- Known active or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require CNS-specific treatment, or participants who did not demonstrate clinical and radiologic stability during the last 2 months prior to the first dose of study treatment or require or are currently on steroid therapy for CNS metastases.
- History of cerebral vascular disease, including transient ischemic attack, within 6 months prior to the first dose of study treatment.
- History of or ongoing impaired cardiac function or clinically significant cardiac disease within 6 months prior to the first dose of study treatment.
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 |
|---|---|---|
| OP-3136Selective inhibitor of HAT enzymes KAT6A and KAT6B | Drug | Part 1A Dose Escalation monotherapy, Part 1B Dose Escalation in combination with fulvestrant, Part 1C Dose Escalation in combination with palazestrant, Part 2A Dose Expansion monotherapy - mBC, Part 2A Dose Expansion monotherapy - mCRPC, Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1, Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2 |
| FulvestrantSelective estrogen receptor degrader (SERD) | Drug | Part 1B Dose Escalation in combination with fulvestrant, Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1, Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2 |
| PalazestrantComplete estrogen receptor antagonist (CERAN) | Drug | Part 1C Dose Escalation in combination with palazestrant, Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 1, Part 2B Dose Expansion in combination with fulvestrant OR palazestrant-mBC @ RDE 2 |
Primary outcome
Number of participants with dose-limiting toxicities in the Dose Escalation Arms
Time frame: Up to 28 days
Incidence of adverse events and laboratory abnormalities
Time frame: Up to 26 months
6 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Up to 26 months
Time to maximum concentration (Tmax)
Time frame: Up to 26 months
Area under the curve from time zero to 24 hours (AUC0-24)
Time frame: Up to 26 months
Overall Response Rate (ORR)
Time frame: Up to 26 months
Duration of Response (DOR)
Time frame: Up to 26 months
Clinical Benefit Rate (CBR)
Time frame: Up to 26 months
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 5 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
There may be multiple sites in this clinical trial Olema Clinical Trial Lead contact
Olema Medical Study Director contact
25 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OP-3136, Fulvestrant and Palazestrant in people with Advanced or Metastatic ER+ HER2- Breast Cancer (mBC) and Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), run by Olema Pharmaceuticals, Inc. at 25 sites in 6 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 6 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Australia, France, Spain, Hong Kong and 1 more country. 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?
Contact There may be multiple sites in this clinical trial Olema Clinical Trial Lead (415-651-7206, clinical@olema.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose-limiting toxicities in the Dose Escalation Arms (time frame: Up to 28 days). The study lists 2 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 5 Oct 2026.