Evaluating SIM0501 for advanced solid tumors

A Phase I First-in-human, Open-label Trial to Investigate the Safety, Pharmacokinetics and Antitumor Activity of SIM0501 as Monotherapy and in Combination in Participants With Advanced Solid Tumors

This study is testing a new treatment called SIM0501 for people with advanced solid tumors to see how safe it is and if it works better alone or with another drug called olaparib.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 176 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06331559 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase 1 clinical trial aims to assess the safety, tolerability, efficacy, and pharmacokinetics of SIM0501 in patients with advanced solid tumors. The trial is divided into two parts: the first part evaluates SIM0501 as a standalone treatment, while the second part examines its effectiveness in combination with olaparib. Participants will receive the treatment until disease progression occurs, intolerable toxicity is experienced, or they choose to withdraw from the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with advanced solid tumors that have progressed after at least one prior treatment and who have specific genetic markers.

Not a fit: Patients who have not progressed on standard treatments or those without the required genetic markers 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 who have limited alternatives.

How similar studies have performed: Other studies have shown promise in targeting advanced solid tumors with similar approaches, but the specific combination of SIM0501 and olaparib is novel.

Eligibility criteria

Inclusion Criteria:

1. Voluntary participation and signature of informed consent form.
2. Aged ≥18 years, male or female.
3. Patients who have histologically confirmed advanced/metastatic solid tumors that meet the following 3 criteria: 1) progressed on at least one prior systematic anti-tumor regimen; 2) have no standard of care (SOC), or are intolerant to SOC, or have no access to SOC; 3) with documented/locally confirmed deleterious or suspected deleterious germline or somatic BRCAm, HRRm or HRD.
4. Has at least one evaluable (described below) or measurable tumor lesion according to RECIST v1.1 , and tumor lesions previously treated with radiotherapy or local therapy should be excluded as measurable lesions unless disease progression has been demonstrated. Palliative radiation therapy is allowed if there are non-radiated measurable disease in other organs.
5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
6. Expected survival ≥12 weeks.

Exclusion Criteria:

1. Patients unable to swallow study drug and patients with gastrointestinal disorders likely to interfere with absorption of the study drug.
2. Patient has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.

   Note: Grade ≤2 AEs with no impact on patient safety are exceptions to this criterion and may qualify for the trial, e.g., Grade ≤2 hair loss and neuropathy caused by chemotherapy.
3. Patient is currently participating or has participated in a trial of an investigational agent or using an investigational device within 4 weeks prior to the first dose of SIM0501, including but not limited to chemotherapy, radiotherapy, target therapy, immunotherapy or other anti-cancer therapies. Note: This does not include participation in the survival follow-up of a trial.
4. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
5. 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 trial.
6. Any other diseases, active or uncontrolled pulmonary dysfunction, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, that may affect the interpretation of the results, or that renders the patient at high risk from treatment complications.
7. Patient is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.

Where this trial is running

Jinan, Shandong

• Shandong Cancer Hospital — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Juan wen Wang

Conditions: Advanced Solid Tumors