OH2 Administered by Intratumoral Injection
ConditionSolid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBinhui Biopharmaceutical Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- OH2 Injection
Treatment groups
29 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov