Evaluating SIM0508 for advanced solid tumors

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

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
• Enrollment: 130 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT06686745 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced ovarian, prostate, breast, or pancreatic cancer who have an ECOG score of 0 or 1.

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.

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 performed: While this approach is novel, similar studies evaluating combination therapies in advanced solid tumors have shown promise in the past.

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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
• Chongqing Cancer Hospital — Chongqing, China (Recruiting)

Study contacts

• Study coordinator: Juan Wen Wang

Conditions Advanced Solid Tumors