SIM0689 in adults with advanced solid tumors
Official title: Phase I First-in-Human, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Run by Jiangsu Simcere Pharmaceutical Co., Ltd. · NCT07660432 · Data updated 2026-11-12
This study tests SIM0689 by itself to see how safe it is and how the body handles it in adults with advanced solid tumors, using a dose-escalation approach and then expanding to specific tumor types at the chosen dose.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 472 (estimated) |
| Sponsor | Jiangsu Simcere Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 6 sites (Fuzhou, Fujian and 5 other locations) |
| Status | Recruiting |
| Started | July 3, 2026 |
| Main results expected | December 2028 |
| Study ends | June 2029 |
| Registry record updated | August 20, 2026 |
| Trial ID | NCT07660432 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy or for which no effective therapy exists, with measurable disease and good performance status.
✕Probably not a fit
Patients with non-measurable disease, those with symptomatic brain metastases, or settings where the drug is not effective may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 1 interventional study of SIM0689 given by injection in adults with locally advanced or metastatic solid tumors. The trial uses a dose-escalation portion to identify the highest safe dose (recommended dose) and a dose-expansion portion to further evaluate safety and early signs of activity at that dose in selected tumor types. Participants must have measurable disease, good performance status, and adequate organ function, with tissue available for biomarker studies. The study excludes patients with symptomatic brain metastases and requires contraception for those who can become pregnant. The lead sponsor is Jiangsu Simcere Pharmaceutical, with collaboration from Shanghai Xianwei Medical Technology, at several Chinese cancer centers.
Why it matters
Potential benefit: If successful, participants may experience disease control signals and contribute to determining a safe dose for future trials.
How similar studies have gone: Early-phase trials of similar approaches have shown safety signals and preliminary activity in solid tumors, but this specific agent is being studied in a novel context.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 gastrointestinal perforation, gastrointestinal bleeding, fistula, or any life-threatening bleeding event within 6 months prior to enrollment. * Prior permanent discontinuation of PD-(L)1 and/or VEGF monoclonal antibody because of immune/anti-angiogenesis toxicities, or history of Grade ≥3 immune/anti-angiogenesis-related AEs * Known or suspected active autoimmune disease. * Patients with proteinuria at screening (Urine protein \>2+ at screening, or 2+ urine protein accompanied by 24-h urine protein ≥1 g/24 h). * History of myocardial infarction or stroke within 6 months prior to enrollment. * Subjects with clinically significant cardiovascular disease within 6 months prior to the first dose. * Pregnant and lactating women. * Known allergies to any excipient in the study drug.
Where it's running
-
Fujian Cancer Hospital
Fuzhou, Fujian, China Recruiting -
The First Affiliated Hospital, Zhejiang University school of Medicine
Hangzhou, Zhejiang, China Recruiting -
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China Not yet recruiting -
Hunan Cancer Hospital
Changsha, Hunan, China Not yet recruiting -
The First Hospital of China Medical University
Shenyang, Liaoning, China Not yet recruiting -
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China Not yet recruiting
Study contacts
- Study coordinator: Tingbo Liang
- Email: liangtingbo_trial@163.com
- Phone: +86 13666676121
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using mesh to prevent hernias after stoma closure in rectal cancer patients
This study is testing if using a special mesh during stoma closure surgery can help prevent hernias in patients with rectal cancer.
-
SIM0613 in people with advanced solid tumors
A first-in-human, multicenter study testing SIM0613 to see if it is safe and tolerable and whether it has any effect in adults with advanced solid cancers.
-
Suvemcitug plus trifluridine/tipiracil for refractory metastatic colorectal cancer
This trial will test whether adding suvemcitug to trifluridine/tipiracil helps people with refractory metastatic colorectal cancer who have already had standard chemotherapy.
-
Testing how SIM0270 interacts with itraconazole, rifampin, and midazolam in healthy Chinese adults
This test will see if SIM0270 changes blood levels of itraconazole, rifampin, or midazolam in healthy Chinese adults.
-
Testing SIM0610 for adults with advanced solid tumors
This will test whether SIM0610 is safe and can shrink tumors in adults with locally advanced or metastatic solid cancers such as non-small cell lung, colorectal, liver, and head and neck cancers.
-
Phase I testing of SIM0609 in adults with advanced or metastatic solid tumors
This trial tests SIM0609 to see if it is safe, tolerated, and can shrink tumors in adults with locally advanced or metastatic solid tumors who have exhausted standard treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.