A Phase I Study of CS5007 in Participants With Advanced Solid Tumors (NCT07622524) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Study of CS5007 in Participants With Advanced Solid Tumors
Australia, China310 participantsStarted 2026-06
Plain-language summary
This is a first-in-human (FIH), open-label, and multi-center Phase I study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of CS5007 as monotherapy in participants with advanced solid tumors. The study is comprised of a Phase Ia dose escalation and Phase Ib dose expansion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
[Dose Escalation] Maximum tolerated dose (MTD) of CS5007
Timeframe: Cycle 1 (Up to 21 Days)
2
[Dose Escalation] Tentative recommended Phase II dose (RP2D) of CS5007
Timeframe: Up to approximately 2 years
3
[Dose Escalation] The incidence and severity of adverse events (AEs)
Timeframe: Up to approximately 2 years
4
[Dose Expansion] Objective response rate (ORR) evaluated by investigators per RECIST v1.1