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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • OH2 Injection

    Drug

    OH2 injection will be given intratumorally, and Q2W.

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: OH2 InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through study completion, an average of about 1 year(a maximum treatment duration of one year)
2

Maximum tolerated dose (MTD)

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

Time frame
up to 1 year

Secondary outcomes

1

Overall response rate (ORR)

Determination of the ORR is calculated based on the proportion of patients achieving complete response (CR) or partial response (PR) using the RECIST v1.1 and modified WHO response criteria as assessed.

Time frame
up to 1 year
2

Disease control rate (DCR)

DCR is defined as the percentage of participants with a best overall response of CR, PR, or stable disease (SD).

Time frame
up to 1 year
3

Biological activity

Granulocyte macrophage colony stimulating factor (GM-CSF) mRNA expression in fine needle aspirate (FNA)(Only for Part 1)

Time frame
up to 1 year
4

Biodistribution

OH2 DNA copy in blood and urine

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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