Oncolytic Virotherapy Plus PD-1 Inhibitor and Lenvatinib for Patients With Advanced Pancreatic Cancer

NCT05303090 | Completed Phase 1

• 1 other identifier: 2201249-8
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety/tolerability efficacy of oncolytic virotherapy combined with Tislelizumab plus lenvatinib for advanced pancreatic cancer patients who were relapsed or refractory to standard therapy

Conditions

Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicities (DLT)

  The DLT assessment period is defined as: Day of Injection through 28 days post injection (Safety Follow Up). A DLT will be defined as any Grade 3 or higher adverse event, as assessed by the National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

  28 days

• Maximum tolerated dose

  A MTD is determined if any cohort experiences 2 subjects with DLT's.

  28 days

• Adverse event (AE)

  max 24 months

Secondary Outcomes (5)

• Objective Response Rate

  max 24 months

• Duration of Response

  max 24 months

• Progression Free Survival

  max 24 months

• Overall survival

  max 42 months

• disease control rate

  max 24 months

Study Arms (1)

H101 + Tislelizumab+ Lenvatinib

EXPERIMENTAL

(Dose escalation and cohort expansion) H101 administered by intratumoral injection in combination with Tislelizumab administered intravenously (IV), and Lenvatinib administered orally.

Drug: H101; Drug: Tislelizumab; Drug: lenvatinib

Interventions

H101 DRUG

H101 intratumorally injection starts at day 0.

H101 + Tislelizumab+ Lenvatinib

Tislelizumab DRUG

Tislelizumab plus lenvatinib will be initiated on day 1. Tislelizumab will be administered at 200 mg i.v. every 3 weeks orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

H101 + Tislelizumab+ Lenvatinib

lenvatinib DRUG

lenvatinib (bodyweight ≥ 60 kg, 12 mg; \< 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.

H101 + Tislelizumab+ Lenvatinib

Eligibility Criteria

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

You may qualify if:

• Written informed consent obtained.
• Age ≥ 18 years at time of study entry.
• Participants must have unresectable or metastatic histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
• Participants had relapsed or been refractory to standard therapy.
• Participants had been unsuitable or unwilling to standard therapy
• At least one measurable site of disease as defined by RECIST criteria with spiral CT scan or MRI.
• Performance status (PS) ≤ 2 (ECOG scale).
• Life expectancy of at least 12 weeks.
• Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥75 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula )
• Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.

You may not qualify if:

• History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
• Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
• Prior treatment with oncolytic virotherapy.
• Radiotherapy administered less then 4 weeks prior to study treatment start.
• Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
• Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
• Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
• Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to:
• history of interstitial lung disease
• Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection)
• known acute or chronic pancreatitis
• active tuberculosis
• any other active infection (viral, fungal or bacterial) requiring systemic therapy
• history of allogeneic tissue/solid organ transplant
• diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Tislelizumab treatment.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China, 200032, China

Location

MeSH Terms

Interventions

tislelizumab; lenvatinib

Study Officials

• Peng Wang, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: March 31, 2022
• Primary Completion: April 23, 2024
• Study Completion: April 23, 2024
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)