Study of SIM0501 Alone and in Combination in Patients With 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 is an open-label, multicenter Phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0501 in participants with advanced solid tumors. The trial consists two parts, Part 1 for SIM0501 monotherapy and Part 2 for SIM0501 in combination with olaparib. In both parts, SIM0501 with/without olaparib will be administered until disease progression or the investigator determines that continuation of the study drug would not benefit, or there is intolerable toxicity, or the participant or legal representative voluntarily requests withdrawal, or the trial is terminated.

Study Overview

• Status: Terminated
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: SIM0501 Tablets; Drug: SIM0501 Tablets; Drug: SIM0501 in combination with olaparib; Drug: SIM0501 in combination with olaparib

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Shandong Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIM0501 mono dose escalation	Drug: SIM0501 Tablets; Every 28 days is one cycle. Multiple dose levels of SIM0501 will be explored in dose escalation, and determine the maximum tolerated dose.; Drug: SIM0501 Tablets; Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 established from SIM0501 mono dose escalation.
Experimental: SIM0501 mono dose optimization	Drug: SIM0501 Tablets; Every 28 days is one cycle. Multiple dose levels of SIM0501 will be explored in dose escalation, and determine the maximum tolerated dose.; Drug: SIM0501 Tablets; Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 established from SIM0501 mono dose escalation.
Experimental: SIM0501 combination dose escalation	Drug: SIM0501 in combination with olaparib; Every 28 days is one cycle.Multiple dose levels of SIM0501 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.; Drug: SIM0501 in combination with olaparib; Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 combination with olaparib established from SIM0501 combination dose escalation.
Experimental: SIM0501 combination dose optimization	Drug: SIM0501 in combination with olaparib; Every 28 days is one cycle.Multiple dose levels of SIM0501 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.; Drug: SIM0501 in combination with olaparib; Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 combination with olaparib established from SIM0501 combination dose escalation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose-limiting toxicity (DLT)	Primary Endpoints	At the end of Cycle 1 (each cycle is 28 days)
Adverse events will be evaluated according to the CTCAE v5.0	Primary Endpoints	The informed consent is signed until 30 days after the last dosing

Collaborators and Investigators

• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Collaborators: Shanghai Xianxiang Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Actual): September 17, 2025
• Study Completion (Actual): September 17, 2025

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; olaparib
• Other Study ID Numbers: SIM0501-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No