Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors

Description

This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to evaluate the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody).

Conditions

Solid Tumor, Adult, Metastatic Solid Tumor, Refractory Cancer

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Study Overview

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Study Details

Study overview

This first-in-human, open-label, multicenter, multi-arm dose-escalation study is designed to evaluate the safety, PK, and PD of ADU-1805, an anti- SIRPα monoclonal antibody, as monotherapy and in combination with pembrolizumab (anti-PD-1 antibody).

An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors

Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors

Condition
Solid Tumor, Adult
Intervention / Treatment

-

Contacts and Locations

Huntersville

Carolina BioOncology Institute - Cancer Research Clinic, Huntersville, North Carolina, United States, 28078

Canton

Gabrail Cancer & Research Center, Canton, Ohio, United States, 44718

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female aged ≥18 years
  • * Signed and dated informed consent form
  • * Histologically and/or cytologically confirmed diagnosis of metastatic or unresectable solid tumors that are refractory to standard therapy or for which no standard therapy exists
  • * Measurable disease according to RECIST (Safety Expansion only)
  • * ECOG Performance status of 0 or 1
  • * Adequate organ and marrow function
  • * Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)
  • * Pregnancy or breast-feeding
  • * Prior treatment with or receipt of:
  • * biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805
  • * chemotherapy, targeted small molecule therapy, hormonal therapy or radiation therapy within 21 days prior to the first dose of ADU-1805 and within 42 days for nitrosoureas and mitomycin C.
  • * anti-SIRPα or anti-CD47-directed therapy
  • * systemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805
  • * other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805
  • * vaccine containing live virus within 28 prior to the first dose of ADU-1805
  • * Active untreated brain metastases
  • * Active infection requiring systemic therapy
  • * Impaired cardiac function or clinically significant cardiac disease
  • * Current Grade \>2 toxicity related to prior anti-cancer therapy
  • * History of drug-induced severe immune-related adverse reaction
  • * Prior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipients
  • * Major surgery within defined period
  • * Diagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosis
  • * Allogenic tissue/solid organ transplant
  • * Any intercurrent illness that is life-threatening or of such clinical significance that it would interfere with the patient's safety or ability to participate in the study

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sairopa B.V.,

Study Record Dates

2025-12