BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors

Advanced Solid Tumors Clinical Trial

— BM201-1001  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368960
• Other study ID #: BM201-1001
• Secondary ID: CTR20223162
• Status: Recruiting
• Phase: Phase 1
• Start date: November 7, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: InnoBM Pharmaceuticals Co., Ltd.
• Contact: Chuntao G PM
• Phone: 86+0512 6938 6599
• Email: ctgong[@]innobm.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Radiation:
• Radiotherapy
Radiation: Hypofractionated radiotherapy

Drug:
• BM201 injection
BM201 injection:Dose escalation:24mg to 240mg

Locations

Country	Name	City	State
China	Nanjing Drum Towel Hospital /The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
InnoBM Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT and MTD	Dose limiting toxicity and maximum tolerated dose	Up to 14 days after the initial treatment
Primary	Pharmacokinetic (PK) parameters	Maximum plasma concentration(Cmax) of the drug after administration	From pre-dose to 96 hrs post-dose
Primary	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	ORR	Objective Response Rate	Up to 42 days after the last treatment
Secondary	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.
Secondary	The variation in peripheral blood tumor biomarker concentrations.	The variation of concentrations of AFP,NSE,CEA ;	Up to 42 days after the last treatment
Secondary	Other exploring outcomes	The variation of tumor tissue biomarker expression levels	Up to 14 days after the initial treatment