A Study of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors (NCT07660432) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
China472 participantsStarted 2027-07
Plain-language summary
This study will evaluate the safety, of SIM0689 and how the body processes it, how it affects the body, and its early signs of activity against tumors when given alone to Adult Participants with Locally Advanced or Metastatic Solid Tumors. The study has a dose escalation part to find the highest dose that can be given safely, or recommended dose (RD) for SIM0689 when given alone, and a dose expansion part in subjects with specific tumor types treated with SIM0689 as a single agent at RD.
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:
* In dose-escalation cohorts (Part 1), histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
* In the dose-expansion cohorts (Part 2), histologically or cytologically confirmed selected advanced solid tumors.
* Subjects 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.
* Available archived tumor tissue sample to allow for correlative biomarker studies. If unavailable or unsuitable, the subject must consent and undergo fresh tumor biopsy.
* Life expectancy ≥12 weeks.
* Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 180 days after the last dose.
Exclusion Criteria:
* Symptomatic brain metastases.
* Serious non-healing wounds, ulcers or fractures.
* Toxicity from previous treatment has to restore to ≤ grade 1.
* Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment.
* Use of aspirin (\> 325 mg/day) within 6 months prior to the first dose.
* Active hepatitis B or hepatitis C.
* Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
* Known hereditary or acquired predisposition to bleeding and thrombosis.
* History of g…
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-limiting toxicity (DLT) (Dose escalation)
Timeframe: at the end of Cycle 1 (each cycle is 28 days)
2
Maximum tolerated dose (MTD)and / or Recommended dose (RD) (Dose escalation)