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Adrenocortical CarcinomaPhase 2NCT07743138

STOMP OUT: A Phase 2 Study To Evaluate The Effects Of Ivonescimab In Patients With Unresectable/Metastatic Adrenocortical Carcinoma (ACC) Or Unresectable Pheochromocytoma/Paraganglioma (PPGL)

A Phase 2 study testing Ivonescimab in people with Adrenocortical Carcinoma and Pheochromocytoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ACC or PPGL. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ivonescimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
7 Feb 2027to 1 May 2030
Phase
Phase 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

None listed.

Who cannot join

  • A subject who meets any of the following criteria is ineligible for the study:
  • Received cytotoxic chemotherapy (including investigational cytotoxic chemotherapy) or biologic agents (e.g., cytokines or antibodies) within 4 weeks of the start of the previous cycle or had received previous targeted therapy including small molecular tyrosine kinase inhibitors such as belzutifan, cabozantinib or lenvatinib within 2 weeks before the first dose of study treatment.
  • Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
  • Major surgical procedures or serious trauma within 4 weeks prior to enrollment or plans for major surgical procedures within 4 weeks after the first dose (as determined by the investigator). Minor local procedures (excluding central venous catheterization and port implantation) within 3 days prior to enrollment.
  • Active autoimmune or lung disease requiring systemic therapy (e.g., with disease modifying drugs, prednisone >10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to first dose of study treatment however the following will be allowed:
  • Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for thyroid, adrenal or pituitary insufficiency) is permitted.
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  • Intermittent use of bronchodilators, inhaled corticosteroids, or local corticosteroid injections is permitted
  • Psoriasis requiring topical treatment only, vitiligo, history of Hashimoto's thyroiditis, Grave's disease, history of radiographic diagnosis of rheumatoid arthritis without active therapy is allowed.
  • Received radionuclide treatment (i.e. I 131 meta-iodo- benzyl guanidine) within 3 months of the first dose of study treatment
  • Receipt of any other type of investigational agent within 28 days before the first dose of study treatment.
  • The subject has not recovered to baseline or CTCAE ≤ Grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant AEs.
  • Symptomatic CNS metastases, CNS metastases with hemorrhagic features, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease Note: Participants must have stopped corticosteroids or be on physiologic corticosteroid replacement therapy (prednisone ≤ 10 mg daily or equivalent).
  • Live vaccine or live attenuated vaccine within 4 weeks prior to planned first dose of study treatment , or if scheduled to receive a live vaccine or live attenuated vaccine during the study period. Inactivated vaccines are permitted.
  • Severe infection within 4 weeks prior to enrollment, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection (as determined by the investigator) requiring systemic anti-infective therapy within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or C)
  • Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 6.0
  • Uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic Note: Participants managed with indwelling catheters (eg, PleurX) are allowed.
  • History of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease
  • Active or prior history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
  • Known history of human immunodeficiency virus (HIV) whose viral load is not controlled.
  • Current use of systemic corticosteroids (>10 mg daily prednisone or equivalent)
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Participants with active hepatitis B are required to have stable or declining levels of hepatitis B DNA by polymerase chain reaction (PCR) on appropriate anti-viral therapy with acceptable tolerability for one month prior to randomization. All participants with active hepatitis C (hepatitis C virus [HCV] antibody positive with HCV RNA levels above the lower limit of detection) are excluded.
  • Known allergy to any component of any study drug; known history of severe hypersensitivity to other monoclonal antibodies
  • History or current evidence of any condition (medical [including adverse events from prior anticancer therapy, disorders secondary to tumor], surgical or psychiatric [including substance abuse]), or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, might lead to higher medical risk and/or is not in the best interest of the participant to participate, in the opinion of the treating investigator
  • Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to randomization is not allowed. The use of full-dose anticoagulants is permitted as long as the international normalized ratio (INR) or activated partial thromboplastin time (aPTT) is within therapeutic limits according to the medical standard of the enrolling institution
  • The subject has experienced any of the following:
  • clinically-significant gastrointestinal bleeding within 6 months before the first dose of study treatment
  • hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood within 3 months before the first dose of study treatment
  • any other signs indicative of pulmonary hemorrhage within 3 months before the first dose of study treatment
  • Radiographic evidence of cavitating pulmonary lesion(s)
  • Tumor invading or encasing any major blood vessels with the exception of tumor thrombus associated with the primary tumor or located within the renal/adrenal vein or vena cava.
  • Evidence of tumor invading the GI tract (esophagus, stomach, small or large bowel, rectum or anus), or any evidence of endotracheal or endobronchial tumor within 28 days before the first dose of ivonescimab
  • Uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
  • Cardiovascular disorders including i. History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 6.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to first dose of study treatment ii. Congestive heart failure (CHF): New York Heart Association (NYHA) Class II, Class III or Class IV at the time of screening iii. Concurrent uncontrolled hypertension defined as sustained BP > 150 mm Hg systolic, or > 100 mm Hg diastolic despite optimal antihypertensive treatment within 7 days of the first dose of study treatment iv. Any history of congenital long QT syndrome v. Any of the following within 12 months before the first dose of study treatment:
  • unstable angina pectoris
  • clinically-significant cardiac arrhythmias
  • stroke (including TIA, or other ischemic event)
  • myocardial infarction
  • CTCAE grade 3 or higher venous thromboembolism
  • Unstable vascular disease (e.g. aortic aneurysm at risk of rupture, Moyamoya disease that required hospitalization) b. Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including: i. Any of the following within 6 months before the first dose of study treatment
  • intra-abdominal tumor/metastases invading GI mucosa
  • active peptic ulcer disease; participants must be completely recovered
  • inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis; participants must be completely recovered from these conditions
  • abdominal fistula
  • gastrointestinal perforation
  • bowel obstruction or gastric outlet obstruction
  • intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with ivonescimab even if the abscess occurred more than 6 months before the first dose of study treatment. c. Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy
  • Pregnant or breastfeeding.
  • A previously identified allergy or hypersensitivity to components of the study treatment formulation.
  • Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
  • Evidence within 2 years of the start of study treatment of another malignancy which required systemic treatment except for cured nonmelanoma skin cancer, cured in situ cervical carcinoma, or evidence of localized adenocarcinoma of the prostate Gleason score 6 (3+3) or 7 (3+4 or 4+3) undergoing active surveillance.
  • Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality which, in the judgment of the investigator, would have made the participant inappropriate for entry into this study.

Trial locations and contacts

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

Matthew Campbell, MD contact

713-563-3877

MCampbell3@mdanderson.org

Virginia R Bayer contact

Virginia

VRBayer@mdanderson.org

United States1 site

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Matthew Campbell, MD, 713-563-3877, MCampbell3@mdanderson.org

    Matthew Campbell, MD

Other trials in United States

About this study

To learn if ivonescimab can help to control previously treated, locally advanced or metastatic ACC or PPGL.

Read the detailed description

Primary Objectives To estimate objective response rate (ORR) in both arms.

Secondary Objectives

  1. To estimate progression free survival in both arms
  2. To estimate overall survival in both arms
  3. To estimate disease control rate
  4. To evaluate safety of the study drug in both arms
Being tested
Ivonescimab
Medical subject headings
Adrenocortical Carcinoma, Pheochromocytoma, Paraganglioma

What participants receive

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

  • IvonescimabDrug

    Given by IV

Study groups in NCT07743138
Study groupRoleWhat they receive
Cohort 1ExperimentalTreatment with Ivonescimab (IV) Q3W For ACC
Receives: Drug: Ivonescimab
Cohort 2ExperimentalTreatment with Ivonescimab (IV) Q3W For PPGL Suspended: No
Receives: Drug: Ivonescimab

What is being measured

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

  1. Safety and adverse events (AEs)

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: Through study completion; an average of 1 year.

Timeline

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

  1. First posted3 Aug 2026
  2. Study start7 Feb 2027 (estimated)
  3. Primary completion1 May 2028 (estimated)
  4. Study completion1 May 2030 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07743138
Sponsor's protocol ID
2026-0427
Other IDs
NCI-2026-05747
Status last verified
Sep 2026
First submitted
28 Jul 2026
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ivonescimab in people with Adrenocortical Carcinoma and Pheochromocytoma, run by M.D. Anderson Cancer Center at 1 site 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 0 inclusion and 52 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: opening soon, as of the sponsor's last update on 18 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 1 site 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 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 Matthew Campbell, MD (713-563-3877, MCampbell3@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). 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 NCT07743138.

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 18 Sep 2026.

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