A Phase Ib/II Clinical Trial of PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor

NCT06026501 | Not Yet Recruiting Phase 1

• 1 other identifier: YL-0116-002
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a one-arm, open, multicenter phase 1b/2 clinical trial of PE0116combined with PE0105 in patients with Advanced Solid Tumors, aiming at exploring the MTD and RP2D and observing the preliminary efficacy.The trial can be divided into two parts: dose escalation part and expansion part.PE0105 is administered as a fixed-dose intravenous injection(3mg/kg Q3w）.

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• Dose limited toxicities evaluated by NCI-CTCAE v5.0

  Incidence of dose limited toxicities and associated dose of PE0105 and PE0116

  From time of first dose to 21 days after the first dose.

• Adverse events evaluated by NCI CTCAE v5.0

  Incidence of adverse events and associated dose of PE0105 and PE0116

  From time of first dose to 90 days after the last dose.

• Recommended Phase 2 Dose

  Recommended dose for phase II clinical trial is explored through dose escalation in phase Ib clinical trial.

  From time of first dose of the first patient to the last dose of the last patient in phase 1b..

• Objective response rate

  The proportion of subjects who have a Complete Response or Partial Response

  From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.

Secondary Outcomes (2)

• Disease control rate

  From the first dose to the date of disease progression or date of death from any cause, whichever comes first，up to 24months.

• Plasma concentration of PE0116 and PE0105

  From one hour before the first dose to 90 days after the last dose.

Study Arms (1)

PE0116+PE0105

EXPERIMENTAL

PE0116 injection will be given 1mg/kg or 2mg/kg every three weeks and PE0105 injection will be given 3mg/kg every threee weeks until there appears evidence of progressive disease, intolerable toxicity, or the patient discontinues from the study treatment for other reasons.

Drug: PE0116,PE0105

Interventions

PE0116,PE0105 DRUG

1. PE0116: 4-1BB Agonist Antibody Drug 2. PE0105: PD-1 Monoclonal Antibody Drug

Also known as: PE0116 injection，PE0105 injection

PE0116+PE0105

Eligibility Criteria

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

You may qualify if:

• Patients who voluntarily sign the informed consent form, understand the study and are willing to follow and able to complete all study procedures,
• Male or female, 75 ≥ age ≥ 18 years,
• Patients enrolled in Phase Ib are those with histopathologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent solid tumors (ovarian cancer, cervical cancer, renal cancer, head and neck cancer, etc.) who have failed to respond to or are intolerant to standard treatment regimens or have no standard effective treatment regimen, and at least one evaluable lesion meeting the definition of RECISTv1.1,
• Patients enrolled in Phase II must have at least 1 measurable lesion consistent with the definition of RECISTv1.1 and need to meet one of the following tumor types: a).histologically and/or cytologically confirmed diagnosis of advanced renal cancer, head and neck cancer, or cervical cancer who have failed at least 1 line of prior therapy with PD-1 and anti-PD-1/PD-L1 antibodies alone or in combination with chemotherapy; failure of anti-PD-1/PD-L1 antibodies is defined as disease progression after achieving complete response (CR) or partial response (PR) with anti-PD-1/PD-L1 antibodies alone or in combination with chemotherapy, or disease progression after ≥ 6 months of stable disease (SD); b). histologically and/or cytologically confirmed diagnosis of ovarian cancer who have received 1 line of prior therapy consisting of at least 1 platinum agent and imaging evidence of disease progression within 6 months of the last dose of platinum-based chemotherapy,
• Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,
• Patients who have a life expectancy of at least 3 months,
• Patients who are ≥ 4 weeks after receiving anti-tumor therapy, such as chemotherapy, radiotherapy, biotherapy, endocrine therapy and immunotherapy before the first dose of study drug,
• Patients need to have appropriate organ and hematopoietic function, laboratory tests，
• Male and female patients of childbearing potential should agree to use effective contraception from the signing of the informed consent form until 3 months after the last dose.

You may not qualify if:

• Patients with clinically symptomatic central nervous system metastases and/or carcinomatous meningitis,
• Patients who have previously failed to recover from adverse reactions to CTCAE V5.0 grade ≤ 1,
• Uncontrolled stable systemic disease with treatment，
• Any active autoimmune disease or documented autoimmune disease, or systemic syndrome previously requiring systemic steroids or immunosuppressive drugs，
• Patients who require systemic corticosteroids (at doses equivalent to \> 10 mg prednisone/day) or other immunosuppressive drugs within 14 days before enrollment or during the study，
• History of infection with human immunodeficiency virus, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation, or stem cell transplantation，
• Patients who have pulmonary tuberculosis and are in active phase at screening，
• Patients with active chronic hepatitis B or active hepatitis C，
• Patients who have received anti-4-1BB target drugs，
• Known subjects who have previously treated with macromolecular protein agents/monoclonal antibodies, or known to have a serious allergic reaction to any component of the test drug (CTCAE V5.0 grade greater than 3)，
• Patient plan to have major surgery during this study including a 28-day screening period，
• Severe infection within 4 weeks before the first dose,Or patients with active infection requiring intravenous antibiotics within the first 2 weeks,
• Patient participated in other clinical trials of drugs within 4 weeks before enrollment and have been enrolled in drug therapy, or did not reach 4 weeks after the end of treatment (EOT),
• Patient had a history of alcoholism, drug abuse or drug abuse within the past 1 year,
• Patien had ≥ grade 3 irAEs or ≥ grade 2 immune-related myocarditis in previous immunotherapy,

Sponsors & Collaborators

• Shanghai YingLi Pharmaceutical Co. Ltd.: lead
• Shanghai HyaMab Biotech Co.,Ltd.: collaborator

Central Study Contacts

Hanying Bao, PhD

CONTACT

86 21-51370693; hybao@yl-pharm.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: August 15, 2023
• First Posted: September 7, 2023
• Study Start: August 31, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 7, 2023

Record last verified: 2023-09