Can a new drug shrink tumors that resist standard care?
NCT ID NCT07807345
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental drug called STRO-006 in adults with advanced solid tumors, including head and neck, lung, esophageal, gastric, colorectal, endometrial, bladder, and breast cancers that have not responded to standard treatments. The study has three parts: first, finding a safe dose of STRO-006 alone; second, testing that dose in more people to see if it shrinks tumors; and third, combining STRO-006 with the immunotherapy drug pembrolizumab. The main goals are to check safety, side effects, and whether the drug shows any anti-tumor activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- STRO-006, an experimental antibody-drug conjugate, given alone or with pembrolizumab
- What this could lead to
- If STRO-006 proves safe and effective, it could offer a new treatment option for people with advanced solid tumors that have stopped responding to existing therapies.
- What could go wrong
- This is an early-phase trial, so the drug may not work or may cause serious side effects. The results will only show preliminary activity, not a proven benefit.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 285 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Histologically or cytologically documented refractory solid tumors that are recurrent or metastatic including: HNSCC (excluding EBV-positive nasopharyngeal carcinoma), NSCLC, esophageal/gastric cancer, colorectal cancer, endometrial carcinoma, urothelial carcinoma, and breast cancer (HR-positive \[HER2-positive or HER2-negative\] and TNBC subtype) * Age ≥ 18 years * Life expectancy of at least 3 months * Willingness and ability to comply with the study protocol and long * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1-term follow-up (LTFU) assessments * Has received standard systemic therapies with known clinical benefit, or is considered inappropriate for such therapies, in the opinion of the investigator. In the dose escalation Phases (Parts 1A and 1C), there is no limit on the number of prior therapies * Expansion Phase (Part 1B) only: Up to two prior therapies are allowed. For participants with AGA-driven adenocarcinoma NSCLC up to four prior therapies are allowed * Measurable disease per RECIST v1.1. * Adequate hematologic and organ function Exclusion Criteria: * Prior anticancer treatment with an ADC with a TOP1 inhibitor payload. (Prior therapy with an ITGB6-targeted ADC is otherwise allowed.) * Prior anticancer therapy (prior to first dose of study treatment): chemotherapy within ≤ 2 weeks, ICI ≤ 3 weeks, ADCs ≤ 3 weeks, palliative radiation therapy ≤ 2 weeks, and major surgery ≤ 4 weeks of C1D1. If not specified, ≥ 5 half-lives or 2 weeks, whichever is longer, since administration of prior therapy must have elapsed * Residual Common Terminology Criteria for Adverse Events (CTCAE) v5 ≥ Grade 2 toxicity from prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 peripheral neuropathy, which is controlled, and endocrinopathies secondary to prior ICI controlled by hormonal treatment. For Part 1C only: discontinued prior immunotherapy due to treatment-related toxicity * Untreated or active brain metastases and/or leptomeningeal disease * Participants with active ILD or active, non-infectious pneumonitis or a history of active pneumonitis ≤ 6 months from the first dose of study treatment * Significant, concurrent renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease that could impact participation in this clinical trial * Previous solid organ or bone marrow transplantation * Concurrent participation in another therapeutic treatment trial
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Massachusetts General Brigham
Boston, Massachusetts, 22031, United States
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NEXT Oncology Dallas
Irving, Texas, 75039, United States
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NEXT Oncology Virginia
Fairfax, Virginia, 22031, United States
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OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
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SCRI at Florida Cancer Specialists
Orlando, Florida, 32829, United States
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Texas Tech University Health Sciences Center
Lubbock, Texas, 79415, United States
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UCSD Moores Cancer Center
La Jolla, California, 92093, United States
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Other studies related to the condition(s) this trial covers.
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- Ivosidenib plus mFOLFOXIRI and celecoxib as a treatment for BRAF-targeted therapy-refractory BRAF V600E-mutant colorectal cancer patients: a phase II study
- Can a new drug shrink advanced solid tumors?
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