BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors (BM201-1001)

The Study to Evaluate the Safety, PK, and Preliminary Efficacy of BM201 Injection Combined With Radiotherapy in Patients With Unresectable Locally Advanced or Metastatic Solid Tumors That Failed Standard Therapy

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Radiation: Radiotherapy; Drug: BM201 injection

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chuntao G PM; Phone Number: 86+0512 6938 6599; Email: ctgong@innobm.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School
      • Contact: Juan L GCP Director; Phone Number: 800-555-5555; Email: njglyygcp@163.com
      • Principal Investigator: Baorui L Chief Physician

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiotherapy; Radiation：Hypofractionated radiotherapy	Radiation: Radiotherapy; Radiation： Hypofractionated radiotherapy; Other Names: RT
Experimental: BM201 injection combined with radiotherapy; BM201 injection：Intratumoral injection Radiation：Hypofractionated radiotherapy	Radiation: Radiotherapy; Radiation： Hypofractionated radiotherapy; Other Names: RT; Drug: BM201 injection; BM201 injection：Dose escalation：24mg to 240mg; Other Names: BM201

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLT and MTD	Dose limiting toxicity and maximum tolerated dose	Up to 14 days after the initial treatment
Pharmacokinetic (PK) parameters	Maximum plasma concentration(Cmax) of the drug after administration	From pre-dose to 96 hrs post-dose
Number of patients with adverse events (AEs)	Number of patients with treatment-related adverse events (AEs)	From the first treatment to 42 days after the last treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Objective Response Rate	Up to 42 days after the last treatment
Peripheral blood cytokine profiling in study participants.	To investigate the change of peripheral blood cytokine level in subjects after the treatment.	From pre-dose/pre-radiation to 4 hrs post-dose/post-radiation.
The variation in peripheral blood tumor biomarker concentrations.	The variation of concentrations of AFP，NSE，CEA ；	Up to 42 days after the last treatment
Other exploring outcomes	The variation of tumor tissue biomarker expression levels	Up to 14 days after the initial treatment

Collaborators and Investigators

• Sponsor: InnoBM Pharmaceuticals Co., Ltd.
• Investigators: Principal Investigator: Baorui L Chief Physician, PH.D, Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 7, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: BM201-1001; CTR20223162 (Registry Identifier: National Medical Products Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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