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

NCT ID: NCT06331559

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SIM0501 mono dose escalation

Group Type: EXPERIMENTAL

SIM0501 Tablets

Intervention Type: DRUG

Every 28 days is one cycle. Multiple dose levels of SIM0501 will be explored in dose escalation, and determine the maximum tolerated dose.

SIM0501 mono dose optimization

Group Type: EXPERIMENTAL

SIM0501 Tablets

Intervention Type: DRUG

Every 28 days is one cycle.Patients will be administered a potential recommended dose of SIM0501 established from SIM0501 mono dose escalation.

SIM0501 combination dose escalation

Group Type: EXPERIMENTAL

SIM0501 in combination with olaparib

Intervention Type: DRUG

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.

SIM0501 combination dose optimization

Group Type: EXPERIMENTAL

SIM0501 in combination with olaparib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Xianxiang Medical Technology Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Jiangsu Simcere Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shandong Cancer Hospital

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Juan wen Wang

Role: CONTACT

wangwenjuan4@zaiming.com

18630999743 ext. +86

Facility Contacts

Jinming Yu

Role: primary

sdyujinming@126.com

0531-67626971

Other Identifiers

SIM0501-101

Identifier Type: -

Identifier Source: org_study_id