NCT06686745 Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors
| NCT ID | NCT06686745 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Jiangsu Simcere Pharmaceutical Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2024-12-06 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 130 participants in total. It began in 2024-12-06 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK/PD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic solid tumors.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06686745 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06686745 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06686745 currently recruiting?
Yes, NCT06686745 is actively recruiting participants. Contact the research team at wangwenjuan4@zaiming.com for enrollment information.
Where is the NCT06686745 trial being conducted?
This trial is being conducted at Shanghai, China, Chongqing, China.
Who is sponsoring the NCT06686745 clinical trial?
NCT06686745 is sponsored by Jiangsu Simcere Pharmaceutical Co., Ltd.. The trial plans to enroll 130 participants.