BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors

NCT ID: NCT06368960

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2024-12-31

Brief Summary

This is a non-randomized，open-label，controlled multi-center Phase Ⅰ study to evaluate tolerability, pharmacokinetics, and preliminary efficacy of BM201 injection in combination with radiotherapy in patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors who have failed standard therapy or are unable to receive standard treatment.

Detailed Description

This is a Phase I, open-label clinical study primarily designed to evaluate the safety and tolerability of BM201 injection in combination with radiotherapy in patients with advanced solid tumors.

Conditions

Advanced Solid Tumors

Study Design

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

Study Groups

Radiotherapy

Radiation：Hypofractionated radiotherapy

Group Type: EXPERIMENTAL

Radiotherapy

Intervention Type: RADIATION

Radiation： Hypofractionated radiotherapy

BM201 injection combined with radiotherapy

BM201 injection：Intratumoral injection Radiation：Hypofractionated radiotherapy

Group Type: EXPERIMENTAL

Radiotherapy

Intervention Type: RADIATION

Radiation： Hypofractionated radiotherapy

BM201 injection

Intervention Type: DRUG

BM201 injection：Dose escalation：24mg to 240mg

Interventions

Radiotherapy

Radiation： Hypofractionated radiotherapy

Intervention Type: RADIATION

BM201 injection

BM201 injection：Dose escalation：24mg to 240mg

Intervention Type: DRUG

Other Intervention Names

RT; BM201

Eligibility Criteria

Inclusion Criteria

1. Unresectable advanced or metastatic solid tumors, either refractory to standard therapy or ineligible for standard treatment.

2. ECOG performance status score of 0-2 point;

3. Expected survival of ≥3 months.

4. At least one measurable lesion by irRECIST criteria, and eligible for intratumoral injection.

5. Prior anti-tumor treatments should be paused for at least 4 weeks before trial initiation，with toxicity related to anti-cancer treatment recovered to ≤Grade 1.

6. Adequate organ and bone marrow function

Exclusion Criteria

1. Patients with active brain metastasis and/or leptomeningeal carcinomatosis，exempt for asymptomatic brain metastases or stable metastatic lesions for a minimum of 4 weeks.

2. Allergic: History of hypersensitivity to active ingredients or any other components of the study medication; cumulative two or more allergies to contrast agents, other drugs, or food.

3. Active hepatitis B or positive antibodies for hepatitis C, human immunodeficiency virus (HIV), or syphilis.

4. Severe cardiac or cerebrovascular conditions, uncontrolled diabetes, hypertension not well-managed medically (systolic >140 mmHg and/or diastolic >90 mmHg), serious infections (active within 14 days before first drug administration/radiotherapy), active GI ulcers, and immune dysfunction.

5. Presence of other active malignancies or history thereof, except for previously managed non-invasive skin basal or squamous cell carcinomas with a 5-year recurrence-free interval, cervical carcinoma in situ, and ductal carcinoma in situ of the breast.

6. Uncontrolled third-space effusions such as pericardial, abdominal, or pleural within 2 weeks before the initial treatment.

7. Administration of corticosteroids within the preceding 2 weeks before initial treatment.

8. Receipt of vaccination within 2 weeks prior to initial therapy.

9. Participation in clinical trial involving drugs or biologics within 4 weeks before the initial treatment.

10. History of major surgery within 3 months prior to initial treatment or scheduled major surgery during the clinical trial period.

11. Prior blood donation or major hemorrhage (>450 mL) within 3 months before initial therapy, or intention to donate blood/blood components during or within 3 months after the trial.

12. Patients with difficult venous access or intolerance to venipuncture, and those unable to tolerate intratumoral injection.

13. Pregnant (positive pregnancy test) and lactating females.

14. Subjects planning pregnancy or gamete donation within 3 months post-consent and unwilling to practice effective contraception.

15. Patients deemed ineligible for enrollment by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

InnoBM Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baorui L Chief Physician, PH.D

Role: PRINCIPAL_INVESTIGATOR

Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School

Locations

Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chuntao G PM

Role: CONTACT

ctgong@innobm.cn

86+0512 6938 6599

Facility Contacts

Juan L GCP Director

Role: primary

njglyygcp@163.com

800-555-5555

Other Identifiers

CTR20223162

Identifier Type: REGISTRY

Identifier Source: secondary_id

BM201-1001

Identifier Type: -

Identifier Source: org_study_id