Evaluating SIM0508 for advanced solid tumors
Official title: A Phase I, First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0508 Monotherapy and Combination Therapy in Adult Participants With Locally Advanced/Metastatic Solid Tumors
Run by Jiangsu Simcere Pharmaceutical Co., Ltd. · NCT06686745 · Data updated 2026-11-12
This study is testing a new treatment called SIM0508, alone and with another drug, to see if it can help people with advanced ovarian, prostate, breast, or pancreatic cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | Jiangsu Simcere Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Status | Recruiting |
| Started | December 6, 2024 |
| Main results expected | June 30, 2027 |
| Study ends | December 30, 2028 |
| Registry record updated | January 7, 2025 |
| Trial ID | NCT06686745 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with advanced ovarian, prostate, breast, or pancreatic cancer who have an ECOG score of 0 or 1.
✕Probably not a fit
Patients with active hepatitis B or C infections, HIV, or those unable to swallow the study drug may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, open-label, first-in-human study aims to assess the safety and efficacy of SIM0508, both as a standalone treatment and in combination with olaparib, in patients with advanced solid tumors. The trial will involve participants with histologically confirmed ovarian, prostate, breast, or pancreatic cancers. The study will monitor pharmacokinetics and pharmacodynamics to understand how the drug behaves in the body and its potential therapeutic effects.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors.
How similar studies have gone: While this approach is novel, similar studies evaluating combination therapies in advanced solid tumors have shown promise in the past.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntary participation and signature of informed consent form. 2. Participants with histologically confirmed ovarian cancer, prostate cancer,breast cancer , or pancreatic cancer. 3. ECOG score of 0 or 1. 4. Expected survival ≥ 12 weeks. Exclusion Criteria: 1. Active hepatitis B (HBsAg or HBcAb positive and HBV DNA≥1×104 copies/mL or≥2000 international unit \[IU\]/mL) or hepatitis C (HCV antibody positive and HCV RNA≥ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the study. 2. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS). 3. Participants unable to swallow study drug and participants with gastrointestinal disorders likely to interfere with absorption of the study drug. 4. Toxicities from previous anticancer therapies have not resolved (e.g to ≤ Grade 1). 5. Pregnant or nursing (lactating) women; other women of childbearing potential, unless the blood pregnancy test within 7 days of first dose of study drug is negative, and participants agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 or olaparib, whichever comes later. 6. Male partinipants with female partners of reproductive potential, unless they agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 and 90 days after the last dose of olaparib, whichever comes later.
Where it's running
-
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China Recruiting -
Chongqing Cancer Hospital
Chongqing, China Recruiting
Study contacts
- Study coordinator: Juan Wen Wang
- Email: wangwenjuan4@zaiming.com
- Phone: 65212241
Similar studies
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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.