BM201 in Combination With Radiotherapy in Patients With Advanced Solid Tumors

NCT06368960 | Recruiting Phase 1

• 2 other identifiers: BM201-1001CTR20223162
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• ORR

  Up to 42 days after the last treatment

• Peripheral blood cytokine profiling in study participants.

  From pre-dose/pre-radiation to 4 hrs post-dose/post-radiation.

• The variation in peripheral blood tumor biomarker concentrations.

  Up to 42 days after the last treatment

• Other exploring outcomes

  Up to 14 days after the initial treatment

Study Arms (2)

Radiotherapy

EXPERIMENTAL

Radiation：Hypofractionated radiotherapy

Radiation: Radiotherapy

BM201 injection combined with radiotherapy

EXPERIMENTAL

BM201 injection：Intratumoral injection Radiation：Hypofractionated radiotherapy

Radiation: Radiotherapy; Drug: BM201 injection

Interventions

Radiotherapy RADIATION

Radiation： Hypofractionated radiotherapy

Also known as: RT

BM201 injection combined with radiotherapy; Radiotherapy

BM201 injection DRUG

BM201 injection：Dose escalation：24mg to 240mg

Also known as: BM201

BM201 injection combined with radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable advanced or metastatic solid tumors, either refractory to standard therapy or ineligible for standard treatment.
• ECOG performance status score of 0-2 point;
• Expected survival of ≥3 months.
• At least one measurable lesion by irRECIST criteria, and eligible for intratumoral injection.
• 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.
• Adequate organ and bone marrow function

You may not qualify if:

• Patients with active brain metastasis and/or leptomeningeal carcinomatosis，exempt for asymptomatic brain metastases or stable metastatic lesions for a minimum of 4 weeks.
• 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.
• Active hepatitis B or positive antibodies for hepatitis C, human immunodeficiency virus (HIV), or syphilis.
• 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.
• 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.
• Uncontrolled third-space effusions such as pericardial, abdominal, or pleural within 2 weeks before the initial treatment.
• Administration of corticosteroids within the preceding 2 weeks before initial treatment.
• Receipt of vaccination within 2 weeks prior to initial therapy.
• Participation in clinical trial involving drugs or biologics within 4 weeks before the initial treatment.
• History of major surgery within 3 months prior to initial treatment or scheduled major surgery during the clinical trial period.
• 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.
• Patients with difficult venous access or intolerance to venipuncture, and those unable to tolerate intratumoral injection.
• Pregnant (positive pregnancy test) and lactating females.
• Subjects planning pregnancy or gamete donation within 3 months post-consent and unwilling to practice effective contraception.
• Patients deemed ineligible for enrollment by the investigator.

Sponsors & Collaborators

• InnoBM Pharmaceuticals Co., Ltd.: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Baorui L Chief Physician, PH.D

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuntao G PM

CONTACT

86+0512 6938 6599; ctgong@innobm.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 16, 2024
• Study Start: November 7, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)