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

NCT05856981
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
130
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Lead sponsor
Sairopa B.V.
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Start date
2023-04-03
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Number of sites
11
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Summary
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).
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Short title
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
clinicaltrials.gov
Official title
An Open-Label, Multicenter, Multi-arm Phase 1 Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-07-01
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First posted
2023-05-12
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Registry last updated
2026-10-28
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Primary completion date
2027-05-01
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Start date
2023-04-03
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Participants
130
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Participant count basis
Estimated
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Planned participants
130
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Protocol amendments
2
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Number of sites
11
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sairopa B.V.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05856981
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ClinicalTrials.gov ID
NCT05856981
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Escalation Phase: Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters

    Timeframe: First 21 days of treatment

    Incidence of DLTs and incidence and severity of TEAEs, classified according to NCI-CTCAE v. 5.0

  2. Expansion Phase: Evaluate the clinical response of ADU-1805 plus pembrolizumab administered as an intravenous (IV) infusion.

    Timeframe: Through study completion, up to 2,5 years

    Objective tumor response rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  1. Escalation and Expansion Phase: Pharmacokinetics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab, serum concentration-time profile and PK parameters

    Timeframe: Through study completion, up to 2,5 years

    Serum concentration-time profiles and PK parameters (including Cmax, AUC)

  2. Escalation and Expansion Phase: Immunogenicity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab

    Timeframe: Through study completion, up to 2,5 years

    Incidence of anti-ADU-antibodies

  3. Expansion Phase: To confirm safety of ADU-1805 in combination with pembrolizumab as an IV infusion

    Timeframe: Through study completion, up to 2,5 years

    Incidence and severity of treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Male or female aged ≥18 years
  • Signed and dated informed consent form
  • Measurable disease according to RECIST (Safety Expansion only)
  • ECOG Performance status of 0 or 1
  • Adequate organ and marrow function
  • Escalation Phase: 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
  • Expansion Phase: histologically and/or cytologically confirmed diagnosis of advanced PD-(L)1-naïve MSS colorectal cancer (CRC), PD-1 relapsed/refractory patients with either advanced MSS endometrial cancer (EC), renal cell carcinoma (RCC) or non-small cell lung cancer (NSCLC) patients, and that have measurable disease according to RECIST

  • Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)

  • Expansion Phase:

    • > 3 lines of prior systemic treatments
    • MSS colorectal cancer (CRC): liver metastasis present

  • 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

Sources for eligibility
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  • Henry Ford Cancer InstituteDetroit, United StatesRecruiting
  • Washington University Medical CampusSt Louis, United StatesRecruiting
  • Atrium Health Carolinas Medical CenterCharlotte, United StatesRecruiting
  • Gabrail Cancer & Research CenterCanton, United StatesRecruiting
  • The Ohio State University Comprehensive Cancer CenterColumbus, United StatesRecruiting
  • University of Texas Southwestern Medical CenterDallas, United StatesRecruiting
  • Start Center for Cancer Research - Mountain RegionWest Valley City, United StatesRecruiting
  • Virginia Cancer SpecialistsFairfax, United StatesRecruiting
  • Grand Hopital de Charleroi (GHdC) - Hopital Notre DameCharleroi, BelgiumRecruiting
  • Hosp 12 de OctubreMadrid, SpainRecruiting
  • Hospital General Universitario Gergorio MaranonMadrid, SpainRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (7)

Targets (1)