Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors

Trial Title: Study of SIM0501 Alone and in Combination in Patients With Advanced Solid Tumors

NCT ID: NCT06331559

Condition: Advanced Solid Tumors

Conditions: Official terms:
Neoplasms
Olaparib

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: SIM0501 Tablets
Description: Every 28 days is one cycle. Multiple dose levels of SIM0501 will be explored in dose escalation, and determine the maximum tolerated dose.
Arm group label: SIM0501 mono dose escalation

Intervention type: Drug
Intervention name: SIM0501 Tablets
Description: Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 established from SIM0501 mono dose escalation.
Arm group label: SIM0501 mono dose optimization

Intervention type: Drug
Intervention name: SIM0501 in combination with olaparib
Description: 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.
Arm group label: SIM0501 combination dose escalation

Intervention type: Drug
Intervention name: SIM0501 in combination with olaparib
Description: 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.
Arm group label: SIM0501 combination dose optimization

Summary: 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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Shandong Cancer Hospital

Address:
City: Jinan
Zip: 250117
Country: China

Status: Recruiting

Contact:
Last name: Jinming Yu

Phone: 0531-67626971
Email: sdyujinming@126.com

Start date: March 19, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: Jiangsu Simcere Pharmaceutical Co., Ltd.
Agency class: Industry

Collaborator:
Agency: Shanghai Xianxiang Medical Technology Co., Ltd.
Agency class: Other

Source: Jiangsu Simcere Pharmaceutical Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06331559