AzTrials
AzTrials

Metastatic Malignant Solid NeoplasmPhase 1NCT04585958

Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer

A Phase 1 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Metastatic Malignant Solid Neoplasm and Platinum-Resistant Ovarian High Grade Serous Adenocarcinoma, run by National Cancer Institute (NCI) at 13 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This phase I trial identifies the side effects and best dose of DS-8201a and olaparib in treating patients with HER2-expressing cancers that have spread to other places in the body or cannot be removed by surgery or ovarian cancer that remains despite treatment with a platinum treatment (platinum resistant). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biopsy Procedure, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
13 sitesUnited States
Study dates
21 May 2021to 31 Dec 2026
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

  • DOSE ESCALATION PHASE:
  • Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
  • Patients must have HER2-positive or HER2-expressing tumors determined by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory. Specific requirement of HER2 status is outlined below:
  • Dose Escalation Module 1 and Module 2:
  • HER2 1-3+ expression by IHC OR
  • HER2 amplification by next generation sequencing panel (NGS) or in situ hybridization (ISH) OR
Show all 47Show fewer
  • If local testing is not feasible, patients will submit archival tissue for central HER2 testing to determine eligibility. Patients with unknown or negative HER2 testing will not be eligible
  • Dose Escalation Module 3:
  • HER2 1-2+ expression by IHC OR
  • HER2 amplification by next generation sequencing panel (NGS) or in situ hybridization (ISH) OR
  • If local testing is not feasible, patients will submit archival tissue for central HER2 testing to determine eligibility. Patients with unknown or negative HER2 testing will not be eligible
  • DOSE EXPANSION PHASE:
  • Patients must have histologically confirmed platinum resistant, high grade serous ovarian carcinoma. Platinum resistant is defined as radiographic progression < 6 months following the last dose of platinum therapy
  • HER2 IHC 1+ per local or central testing
  • There must be least one lesion suitable for biopsy without significant risk to the patient
  • Patient disease must be evaluable or measurable by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Biopsiable lesion cannot be the only RECIST-measurable lesion
  • DOSE ESCALATION AND DOSE EXPANSION PHASES:
  • Patients must have had at least one prior line of cytotoxic chemotherapy
  • Patients can have received an unlimited number of additional lines of chemotherapy, targeted therapy, biologic therapy, or hormonal therapy
  • Patients must have archival formalin-fixed paraffin-embedded (FFPE) tissue available for central confirmation of HER2 testing
  • Age >= 18 years. Because no dosing or adverse event data are currently available on the use of DS-8201a in combination with olaparib in patients < 18 years of age, children are excluded from this study
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
  • Hemoglobin >= 10.0 g/dL (within 21 days of randomization/enrollment)
  • No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment
  • Absolute neutrophil count >= 1,000/mcL (within 21 days of randomization/enrollment)
  • No administration of granulocyte colony-stimulating factor (G-CSF) is allowed within 1 week prior to screening assessment
  • Platelets >= 100,000/mcL (within 21 days of randomization/enrollment)
  • No transfusions with red blood cells or platelets are allowed within 1 week prior to screening assessment
  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), (< 3 x ULN in the presence of documented Gilbert's syndrome or liver metastases at baseline) (within 21 days of randomization/enrollment)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN (within 21 days of randomization/enrollment)
  • Creatinine =< 1.5 x institutional ULN OR glomerular filtration rate (GFR) >= 51 mL/min/1.73 m^2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m^2 (using the Cockcroft-Gault Equation) (within 21 days of randomization/enrollment)
  • Patients must have left ventricular ejection fraction (LVEF) >= 50% by either an echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization/enrollment
  • Patients who are human immunodeficiency virus (HIV) positive may participate IF they meet the following eligibility requirements:
  • They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective
  • They must have an undetectable viral load and a CD4 count >= 250 cells/uL within 7 days of enrollment
  • They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months
  • HIV-infected patients should be monitored every 12 weeks for viral load and CD4 counts
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with brain metastases should be stable and off steroids and at least 4 weeks from radiation at the time of registration
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be better than class 2B
  • The effects of DS-8201a and olaparib on the developing human fetus are unknown. For this reason and because HER2 antibody conjugated to a topoisomerase 1 inhibitor agents as well as PARP inhibitors are known to be teratogenic; thus, women of child-bearing potential and men must agree to use highly effective contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 7 months (women of childbearing potential [WOCBP] only) after the last dose of study drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of DS-8201a and olaparib administration
  • Women of non-child-bearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases, a blood sample with simultaneous follicle-stimulating hormone [FSH] > 40 mIU/mL and estradiol < 40 pg/mL [< 147 pmol/L] is confirmatory) are eligible. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods outlined for women of child-bearing potential if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method
  • Male subjects must not freeze or donate sperm starting at screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrollment in this study
  • Female subjects must not donate, or retrieve for their own use, ova from the time of screening and throughout the study treatment period, and for at least 7 months after the final study drug administration
  • Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible

Who cannot join

  • Patients who have had chemotherapy (including antibody drug therapy) within 4 weeks with the following exceptions: 1 week for weekly paclitaxel; 2 weeks or five half-lives, whichever is longer, for small-molecule targeted agents such as 5-fluorouracil-based agents, folinate agents, hormonal agents; or 6 weeks for nitrosoureas or mitomycin C
  • Patients who have had radiation therapy within 4 weeks
  • Patients who have had a major surgery within 4 weeks
  • Patients who are receiving any other investigational agents
  • Patients with a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
  • Patients with clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (i.e. pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with potential pulmonary involvement (i.e. rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy
Show all 17Show fewer
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to DS-8201a, the inactive ingredients in the drug product, olaparib, or severe hypersensitivity to other monoclonal antibodies
  • Patients receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
  • Patients with a medical history of myocardial infarction within 6 months before randomization/enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association class IIb to IV), troponin levels consistent with myocardial infarction as defined according to the manufacturer 28 days prior to randomization
  • Patients with a corrected QT interval (QTc) prolongation to > 470 ms (females) or > 450 ms (males) based on average of the screening triplicate 12-lead electrocardiogram (ECG)
  • Patients with multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, and other solid tumors curatively treated
  • Patients with an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
  • Patients receiving chloroquine or hydroxychloroquine will require a washout period of >= 14 days to be eligible for the study
  • Patients with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade =< 1 or baseline. Subjects with chronic grade 2 toxicities may be eligible per the discretion of the investigator after consultation with the sponsor medical monitor or designee (e.g., grade 2 chemotherapy-induced neuropathy)
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study because DS-8201a is a HER2 antibody conjugated to a topoisomerase 1 inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with DS-8201a, breastfeeding should be discontinued if the mother is treated with DS-8201a. These potential risks may also apply to other agents used in this study
  • Patients who have received a live, attenuated vaccine within 30 days prior to the first dose of DS-8201a

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

13 sites in 1 country

United States13 sites, 12 recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Site Public Contact, 888-946-7447

    Kristen Starbuck

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Site Public Contact, 404-778-1868

    Kristen Starbuck

    Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

    Site Public Contact, 877-442-3324

    Elizabeth K. Lee

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

    Site Public Contact, 305-243-2647

    Abdulrahman Sinno

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

    Site Public Contact, 305-243-2647

    Abdulrahman Sinno

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Doral

    Doral, Florida, 33166

    Site Public Contact, kginnity@med.miami.edu

    Abdulrahman Sinno

    Recruiting

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

    Site Public Contact, 855-776-0015

    Andrea E. Wahner Hendrickson

    Recruiting

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

    Site Public Contact, 305-243-2647

    Abdulrahman Sinno

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Kendall

    Miami, Florida, 33176

    Site Public Contact, 305-243-2647

    Abdulrahman Sinno

    Recruiting

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

    Active, not recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Site Public Contact, 412-647-8073

    Sarah E. Taylor

    Recruiting

  • UM Sylvester Comprehensive Cancer Center at Plantation

    Plantation, Florida, 33324

    Site Public Contact, 305-243-2647

    Abdulrahman Sinno

    Recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Site Public Contact, 855-776-0015

    Andrea E. Wahner Hendrickson

    Recruiting

Other trials in United States

About this study

Official title: A Phase I Study of DS-8201a in Combination With Olaparib in HER2-Expressing Malignancies

This phase I trial identifies the side effects and best dose of DS-8201a and olaparib in treating patients with HER2-expressing cancers that have spread to other places in the body or cannot be removed by surgery or ovarian cancer that remains despite treatment with a platinum treatment (platinum resistant). DS-8201a is an antibody-drug conjugate. This agent has two components: an antibody component and a chemotherapy component. The antibody component is attached to the chemotherapy molecules. Upon administration of DS-8201a, the antibody targets and binds to tumor cells that have abundant HER2 (human-epidermal growth factor receptor 2), which is a protein on the surface of some tumor cells. The chemotherapy then enters the cells and blocks deoxyribonucleic acid (DNA) replication in the tumor cells with abundant HER2, causing them to die. Olaparib is a drug that blocks an enzyme involved in many cell functions, including the repair of DNA damage. Blocking this enzyme may help keep tumor cells from repairing their damaged DNA, causing them to die. Giving DS-8201a and olaparib may shrink or stabilize the cancer.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the safety and tolerability of the combination of trastuzumab deruxtecan (DS-8201a) in combination with olaparib, and to determine the recommended phase 2 dose (RP2D).

II. To evaluate the safety and tolerability of this combination in a dose expansion cohort in patients with platinum resistant high grade serous ovarian carcinoma.

SECONDARY OBJECTIVES:

  1. To observe and record anti-tumor activity as measured by objective response rate (ORR), clinical benefit rate, progression-free survival (PFS), and duration of response (DoR).

II. To measure baseline HER2 expression by immunohistochemistry (IHC) in a central laboratory and correlate with response in the dose escalation and in the dose expansion.

III. To evaluate the plasma pharmacokinetic (PK) profiles of olaparib and DS-8201a metabolites when administered in combination in the dose escalation and in the dose expansion.

IV. To determine markers of DNA damage response (DDR) in tumor specimens at baseline and on-treatment in patients with platinum resistant high grade serous ovarian carcinoma in dose expansion.

EXPLORATORY OBJECTIVES:

  1. To measure baseline HER2 expression by immune multiple reaction monitoring-mass spectroscopy (ImmunoMRM), and correlate with baseline central IHC and with response in dose escalation and in dose expansion.

II. To assess the formation of topoisomerase I cleaved complex formation (TOP1cc) in blood specimens and correlate with response in dose escalation and in dose expansion.

III. To assess the formation of TOP1cc in paired on-treatment tumor specimens (after DS-8201a alone and after DS-8201a and olaparib combination) and correlate with response in patients with platinum resistant high grade serous ovarian carcinoma in the expansion.

IV. To measure changes in HER2 expression over the course of treatment by IHC and immunoMRM and correlate with response in patients with platinum resistant high grade serous ovarian carcinoma in dose expansion.

  1. To determine biomarkers of response and resistance in tumor specimens and blood specimens, including whole exome sequencing (WES) and ribonucleic acid (RNA) sequencing.

OUTLINE: This is a dose-escalation study of trastuzumab deruxtecan in combination with olaparib followed by a dose-expansion study.

Patients receive trastuzumab deruxtecan intravenously (IV) over 30-90 minutes on day 1 and olaparib orally (PO) twice daily (BID) on days 1-21, days 8-14, or days 3-9 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients undergo collection of blood samples, echocardiography (ECHO) or multigated acquisition scan (MUGA), computed tomography (CT), and biopsies throughout the trial.

After completion of study treatment, patients are followed up for 30 days.

Being tested
Biopsy Procedure, Biospecimen Collection, Computed Tomography, Echocardiography Test, Multigated Acquisition Scan
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biopsy ProcedureProcedure or surgery

    Also called Biopsy, BIOPSY_TYPE, Bx

    Undergo biopsy

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Undergo collection of blood samples

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo echocardiography

  • Multigated Acquisition ScanProcedure or surgery

    Also called Blood Pool Scan, Equilibrium Radionuclide Angiography, Gated Blood Pool Imaging, Gated Heart Pool Scan

    Undergo MUGA

  • OlaparibDrug

    Also called AZD 2281, AZD-2281, AZD2281, KU 0059436

    Given PO

  • Trastuzumab DeruxtecanBiological

    Also called DS-8201, DS-8201a, Enhertu, Fam-trastuzumab Deruxtecan-nxki

    Given IV

Study groups in NCT04585958
Study groupRoleWhat they receive
Treatment (trastuzumab deruxtecan, olaparib)ExperimentalPatients receive trastuzumab deruxtecan IV over 30-90 minutes on day 1 and olaparib PO BID on days 1-21, days 8-14, or days 3-9 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. All patients undergo collection of blood samples, ECHO or MUGA, CT, and biopsies throughout the trial.
Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Echocardiography Test; Procedure: Multigated Acquisition Scan; Drug: Olaparib; Biological: Trastuzumab Deruxtecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose/recommended phase 2 dose

    Will be measured by Common Terminology Criteria for Adverse Events version (v) 5.0 and analyzed using descriptive statistics.

    Measured: Up to 42 days

  2. Incidence of adverse events

    Measured: Up to 30 days post treatment

Secondary outcomes (6)

  1. Objective response rate (ORR)

    ORR will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria to determine the best overall response for evaluable patients.

    Measured: Up to 30 days post treatment

  2. Clinical benefit rate (CBR)

    CBR will be evaluated by RECIST 1.1 criteria to determine the best overall response for evaluable patients.

    Measured: Up to 30 days post treatment

  3. Duration of response (DOR)

    DOR will be evaluated by RECIST 1.1 criteria to determine the best overall response for evaluable patients. DOR will be described using the method of Kaplan-Meier.

    Measured: Up to 30 days post treatment

  4. HER2 expression

    HER2 expression on archival specimens will be analyzed using current American Society of Clinical Oncology/College of American Pathologists breast cancer and gastric cancer scoring methods. The levels of HER2 expression (0, 1+, 2+, or 3+) will be determined and the number and percentage of patients in each category will be reported. Chi-squared test and regression modeling may be used to investigate any possible relationship of HER2 biomarker levels with anti-tumor efficacy.

    Measured: At baseline

  5. Plasma pharmacokinetic (PK) profiles

    PK will be analyzed using descriptive statistics. Analysis of variance and regression model may be used to investigate any possible relationship of PK biomarker levels with anti-tumor efficacy

    Measured: Up to 30 days post treatment

  6. Markers of deoxyribonucleic acid (DNA) damage response (DDR)

    Markers of DDR will be measured by multiplex IF in tumor specimens at baseline and on-treatment in patients with platinum resistant high grade serous ovarian carcinoma in the dose expansion cohort and correlating these markers with response. For the DDR assay, levels exceeding 4% nuclear area positive (NAP) γH2AX, 4% NAP pNBS1, and 5% cells with ≥ 5 Rad51 nuclear foci indicate a DNA damage activation response (Wilsker et al., 2019).

    Measured: At baseline and on-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start21 May 2021
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04585958
Sponsor's protocol ID
NCI-2020-07841
Other IDs
NCI-2020-07841, 10355, 10355, UM1CA186709
Status last verified
Sep 2026
First submitted
13 Oct 2020
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biopsy Procedure, Biospecimen Collection and Computed Tomography in people with Metastatic Malignant Solid Neoplasm and Platinum-Resistant Ovarian High Grade Serous Adenocarcinoma, run by National Cancer Institute (NCI) at 13 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 47 inclusion and 17 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 8 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 13 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose/recommended phase 2 dose (time frame: Up to 42 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?

On the ClinicalTrials.gov record for NCT04585958.

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 8 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in