Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
All Genders
NCT05801237

PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor

Led by Shanghai HyaMab Biotech Co.,Ltd. · Updated on 2023-12-15

120

Participants Needed

1

Research Sites

166 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a Phase I Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetics and Preliminary Antitumor Activity of PE0116 and PE0105 Injection in Treatment of Patients with Advanced Solid Tumor.

CONDITIONS

Official Title

PE0116 and PE0105 Injection in Treatment of Patients With Advanced Solid Tumor

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign informed consent and able to complete all study procedures
  • Male or female aged between 18 and 75 years
  • Histologically or cytologically confirmed metastatic or unresectable locally advanced, recurrent solid tumors refractory or intolerant to standard treatment or lacking effective standard treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of at least 3 months
  • At least one evaluable lesion in Phase Ia and measurable lesions in Phase Ib per RECIST v1.1
  • At least 4 weeks since last anti-tumor therapy (with specified longer intervals for nitrosourea, mitomycin C, oral fluorouracils, small molecule targeted agents, and traditional Chinese medicine with anti-tumor effects)
  • Suitable organ and hematopoietic function meeting specific laboratory criteria including ANC ≥ 1.5 × 10^9/L, WBC ≥ 3.0 × 10^9/L, platelets ≥ 75 × 10^9/L, hemoglobin ≥ 90 g/L, serum creatinine ≤ 1.5× ULN, liver enzymes and bilirubin within defined limits, coagulation parameters within limits except for anticoagulant therapy, and normal or mildly abnormal myocardial enzyme and thyroid function tests
  • Agreement to use effective contraception from consent signing until 3 months after last dose for males and females of childbearing potential
Not Eligible

You will not qualify if you...

  • Central nervous system metastasis with symptoms or carcinomatous meningitis unless stable for at least 2 months and off systemic hormone therapy for over 4 weeks
  • Unresolved adverse reactions from prior therapies above CTCAE Grade 1 except certain recovered conditions
  • Uncontrolled severe systemic diseases such as cardiovascular, cerebrovascular, diabetes, hypertension
  • Active autoimmune diseases or requiring systemic steroids/immunosuppressants except defined exceptions
  • Need for systemic corticosteroids >10 mg prednisone/day within 14 days prior or during study except allowed topical/inhaled or short-term use
  • History of HIV infection, immunodeficiency, organ or stem cell transplantation
  • Active tuberculosis or active hepatitis B or C infection
  • Prior treatment with anti-4-1BB targeting drugs
  • History of severe allergic reactions to similar drugs or components
  • Planned major surgery during study including screening
  • Serious infection within 4 weeks prior or active infection requiring antibiotics within first 2 weeks
  • Participation in another drug clinical trial within 4 weeks prior or less than 4 weeks after end of treatment
  • History of alcohol or drug abuse in past year
  • Previous or current other primary malignant tumors except certain skin and bladder cancers or those treated and relapse-free for 5 years
  • Moderate or severe dyspnea at rest due to malignancy complications or lung disease, need for continuous oxygen therapy, current interstitial lung disease or pneumonia
  • Use of live attenuated vaccine within 4 weeks prior or planned during study
  • History of neurological or mental disorders affecting compliance
  • Pregnant or breastfeeding women or those not agreeing to reliable contraception during study and 3 months after last dose
  • Any other reason investigator finds unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, China

Actively Recruiting

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Research Team

Y

Ye Han

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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