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Can a new drug tame advanced solid tumors?

NCT ID NCT02561234

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This early-stage trial is testing an experimental drug called AEB1102 in people with advanced solid tumors that have not responded to standard treatments or for which no standard treatment exists. The main goal is to find the highest dose that is safe and to understand the drug's side effects. Participants receive the drug through an IV, and the study will monitor their health closely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AEB1102 (Co-Arg1-PEG), an experimental drug given by IV infusion
What this could lead to
If it works, this could point toward a new treatment option for advanced solid tumors that have not responded to standard therapies.
What could go wrong
This is an early, first-in-human trial focused on safety and dosing, so it may not lead to an effective treatment. There are also potential side effects from the drug, which are being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

76 people

The number who actually took part.

Started

Oct 2015

Finished

May 2019

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: For patients participating in any part of the trial: * has an advanced solid tumor previously treated with, or inability to tolerate, standard therapy for the disease, or for which a standard therapy does not exist, and as such is considered a candidate for Phase 1 treatment * has adequate organ function: Hgb ≥9 g/dL; absolute neutrophil count (ANC) ≥ 1.5x109/L; plt ≥ 100,000/μL; AST and ALT \< 2.5x ULN (\< 5x ULN in patients with liver metastases); total bilirubin \< 2.0 mg/dL; serum creatinine ≤ 1.5x ULN * ECOG performance score 0-2 For patients participating in any expansion group: * has measurable disease based on RECIST 1.1 as determined by the treating investigator. Tumor lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions * willing to consent for biopsy is strongly recommended but not mandatory * recovery of toxicities related to any prior treatments to at least Grade 1 by CTCAE v 4.03. Exceptions are patients with adverse event(s) that are clinically nonsignificant and/or stable on supportive therapy. For patients participating in specific expansion groups: Cutaneous Melanoma: * unresectable, locally advanced or metastatic (AJCC stage IIIB, IIIC, or IV) cutaneous malignant melanoma * relapsed or progressive disease after or unable to tolerate at least one prior systemic anticancer regimen for metastatic disease involving immunotherapy (anti-PD-1, anti-PD-L1, or anti-CTLA-4) * in tumors with a relevant BRAF mutation, relapsed, refactory, or unable to tolerate at least one prior systemic anticancer regimen for metastic disease involving a BRAF inhibitor Uveal Melanoma: * uveal melanoma at metastic stage Small Cell Lung Cancer: * extensive disease previously treated with, or inability to tolerate, platinum-based chemotherapy Exclusion Criteria: * has primary CNS malignancy * history of untreated brain mets or leptomeningeal disease or spinal cord compression * effects of prior anticancer therapy recovered to grade \< 2 * known HIV * active infection * major surgery within 2 weeks * history of another malignancy within 2 years prior

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Columbia University

    New York, New York, 10032, United States

  • Dana Farber

    Boston, Massachusetts, 02114, United States

  • Massachusetts General

    Boston, Massachusetts, 02114, United States

  • Pinnacle Research

    Phoenix, Arizona, 85258, United States

  • Providence Cancer Center

    Portland, Oregon, 97213, United States

  • Research Center: Mid Florida Hematology/Oncology Centers

    Orange City, Florida, 32763, United States

  • UCLA

    Los Angeles, California, 90024, United States

  • UTSW

    Dallas, Texas, 75390-8852, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15232, United States

  • Washington University

    St Louis, Missouri, 93110, United States

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