New drug CS5007 targets tough cancers in first human trial
NCT ID NCT07622524
First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This early-stage trial tests a new drug called CS5007 in people with advanced solid tumors that cannot be removed by surgery. The drug is designed to seek out and attack cancer cells while sparing healthy ones. The study will first find the safest dose and then check if the drug shrinks tumors. About 310 participants will take part across multiple centers.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CS5007 (a bispecific antibody-drug conjugate targeting EGFR and HER3)
- What this could lead to
- If successful, this could lead to a new treatment option for people with advanced solid tumors that have not responded to other therapies.
- What could go wrong
- This is a very early Phase I trial, so the drug may not be safe or effective. Side effects are unknown, and it will take years before any potential benefit is confirmed.
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
-
About 310 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2026
- Expected to finish
-
Jan 2029
An estimate. End dates often move.
- 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 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: * Evidence of a personally signed and dated informed consent document. * Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. * Being ≥ 18 years of age on the day of signing informed consent. * Pathologically or cytologically confirmed, unresectable advanced solid tumors. * Participants must have at least one measurable lesion according to RECIST Version1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1. * Adequate organ function. * Life expectancy ≥ 3 months. * Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 180 days after the last study drug administration Exclusion Criteria: * Has disease that is suitable for local treatment administered with curative intent. * Has a history of a second malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured. * Known primary central nervous system (CNS) tumor or solid tumor CNS metastasis that is symptomatic, untreated, or requires therapy. * Has life-threatening bleeding event or severe bleeding within 3 months prior to first dose. * Has uncontrolled pleural effusion, pericardial effusion, or ascites. * Has immune deficient disease or received systemic immunosuppressive treatment. * Has intestinal obstruction,or history of inflammatory bowel disease,or chronic diarrhea. * Has history of (non-infectious) interstitial lung disease/pneumonitis that required steroids. * Has active infections requiring systemic therapy. * Has significant cardiovascular disease or cerebrovascular accident within specified timeframes prior to first dose. * Insufficient washout from prior anti-tumor therapy. * Received live vaccine within 28 days prior to first dose. * History of allogeneic organ or hematopoietic stem cell transplantation. * History of hypersensitivity to excipients of study drug or any monoclonal antibody. * Any toxic effects of prior therapy unresolved to Grade ≤1. * Active alcohol or drug abuse. * Pregnant or breastfeeding women. * Other acute or chronic medical or psychiatric conditions that may increase risk or interfere with study results, in the investigator's judgment.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
7 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Calvary Mater Newcastle
RECRUITINGWaratah, New South Wales, 2298, Australia
-
Icon Cancer Centre South Brisbane
RECRUITINGSouth Brisbane, Queensland, 4101, Australia
-
Linear Clinical Research Ltd
RECRUITINGNedlands, Western Australia, 6009, Australia
-
Macquarie University
RECRUITINGNorth Ryde, New South Wales, 2109, Australia
-
Shanghai Chest Hospital
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200030, China
-
St Vincent's Hospital Melbourne
NOT_YET_RECRUITINGFitzroy, Victoria, 3065, Australia
-
St Vincent's Hospital Sydney
NOT_YET_RECRUITINGDarlinghurst, New South Wales, 2010, Australia
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human trial asks whether HG381 is safe and tolerable in advanced solid tumors
- Custom-Built immune cells take aim at a notorious cancer mutation
- Experimental injection SHR-7787 put to the test against advanced solid tumors
- Experimental biologic AWT020 put to the test in Hard-to-Treat cancers
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Oral drug RVU120 put to the test against advanced solid tumors