OH2 Administered by Intratumoral Injection

NCT05954091 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: BH-OH2-007
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will be a Phase 1, multi-center, open-label, dose escalation followed by the recommended phase 2 dose (RP2D) expansion study to characterize safety, tolerability, biodistribution, virus shedding and preliminary efficacy of intratumoral injection of OH2 in patients with locally advanced/metastatic solid tumors.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Event (AE) and Serious Adverse Event (SAE)

  Toxic reactions according to the NCI-CTCAE 5.0 grading standard that occur within 3 weeks from the first administration, are judged to be drug-related by the investigator, and meet the non-hematological toxicity and hematological toxicity conditions specified in the clinical protocol

  Through study completion, an average of about 1 year(a maximum treatment duration of one year)

• Maximum tolerated dose (MTD)

  To estimate the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of OH2

  up to 1 year

Secondary Outcomes (5)

• Overall response rate (ORR)

  up to 1 year

• Disease control rate (DCR)

  up to 1 year

• Biological activity

  up to 1 year

• Biodistribution

  3 months

• Viral shedding

  3 months

Study Arms (1)

OH2 Injection

EXPERIMENTAL

Subjects will get OH2 injection every two weeks, and up to 8mL for each treatment. There will have three virus titers: 1×10\^6 CCID50/mL, 5×10\^6 CCID50/mL, 1×10\^7 CCID50/mL.

Drug: OH2 Injection

Interventions

OH2 Injection DRUG

OH2 injection will be given intratumorally, and Q2W.

Also known as: BS001

OH2 Injection

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged ≥ 18 years old
• Subject must have histologically- or cytologically-confirmed diagnosis of unresectable locally advanced or metastatic melanoma, pancreatic cancer, liver metastases from colorectal cancer, breast cancer, and other solid tumors. (Part 1 and Part 2 Cohort A will include patients who have solid tumors with cutaneous/subcutaneous tumor lesions, such as melanoma, cutaneous squamous cell carcinoma, and cutaneous/subcutaneous metastasis from pancreatic cancer, colorectal cancer, breast cancer etc. Part 2 Cohort B will include patients who have visceral tumors.)
• Subject has measurable disease as determined by RECIST version 1.1. At least 1 lesion must be suitable for intratumoral (IT) injection. Lesions for injection must be ≥ 10 mm and ≤ 60 mm in longest diameter.
• Subjects who have progressed on or are ineligible for available standard therapy are eligible for this trial after the last dose of the previous treatment which is ≥ 4 weeks or 5 half-lives (if required) before the first dose of study treatment. Note: patients who have previously been treated with IMLYGIC (Talimogene laherparepvec, T-Vec) are eligible after discontinuing the last dose of previous T-Vec treatment for ≥ 12 weeks before first dose of study treatment.
• Subject has a predicted life expectancy ≥ 12 weeks.
• Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• A female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) OR
• WOCBP who agrees to use an acceptable form of birth control method, including:
• abstinence, hormonal contraception for at least 3 months in combination with a barrier method, intrauterine device (placement at least 3 months prior to screening), cervical cap, condoms with contraceptive gel/foam/cream, or surgical sterilization (tubal ligation at least 6 months prior to screening or partner who had a vasectomy at least 6 months prior to screening).
• Female subject must agree not to breastfeed starting at screening, throughout the study period and 180 days after the final study IP administration.
• Female subject must not donate ova starting at screening, throughout the study period and for 180 days after the final study IP administration.
• Male subject must agree to remain abstinent or use a condom throughout the study period and for 180 days after the final study IP administration.
• Male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 180 days after the final study IP administration.
• Male subject must not donate sperm during the treatment period and for at least 180 days after the final study IP administration.

You may not qualify if:

• Subject has ongoing toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2 attributable to prior antineoplastic therapies considered clinically significant determined by the Investigator.
• Subject has had major surgery ≤ 4 weeks of screening.
• Subject is concurrently participating in another interventional study or has received an investigational product \< 4 weeks or 5 half-lives (if required) prior to first IP administration.
• Subject with symptomatic central nervous system (CNS) metastases, except patients with CNS lesions that have been treated and have no evidence of progression in the brain on CT/MRI for ≥ 3 months and have been off steroids for at least 4 weeks prior to first IP administration.
• Subject with active autoimmune disease requiring systemic therapy within past 2 years. (e.g., systemic lupus erythematosus, Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, hypophysitis, etc.). The following are exceptions to this criterion:
• Subject with vitiligo or alopecia
• Subject with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
• Childhood asthma that has resolved
• Any chronic skin condition that does not require systemic therapy
• Type 1 diabetes mellitus ※Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
• Subject with another malignancy that currently requires treatment.
• Subject with tumors encasing major vascular structures such as the carotid artery, tumors adjacent to vital neurovascular structures or tumors in locations that are at high risk for AEs or otherwise not considered appropriate for IT injection.
• Subject with inadequate organ and marrow functions meeting any of the below criteria:
• with ongoing continuous supportive treatment
• Leukocytes \< 3000/μL

Sponsors & Collaborators

• Binhui Biopharmaceutical Co., Ltd.: lead

Central Study Contacts

Yue Su

CONTACT

+86 17307121014; suyue@binhui-bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: July 20, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share