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

Sponsor
Sairopa B.V. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05856981
Collaborator
(none)
90
Enrollment
2
Arms
31
Anticipated Duration (Months)

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

The study will start with the ADU-1805 monotherapy dose escalation arm following an i3+3 design until the RP2D is defined. The ADU-1805 plus pembrolizumab dose escalation arm, also following an i3+3 design, will start after clearance of the ADU-1805 monotherapy dose level achieving maximum target engagement (e.g. ≥ 90% target engagement) and will continue until the RP2D for the combination is defined.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Monotherapy dose escalation, IV, Q3W, multiple dose levels

ADU-1805 monotherapy dose escalation

Drug: ADU-1805
anti-SIRPα monoclonal antibody
Experimental: Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose

ADU-1805 plus pembrolizumab dose escalation

Drug: ADU-1805
anti-SIRPα monoclonal antibody

Drug: Pembrolizumab
Keytruda
Other Names:
  • Keytruda

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence and severity of dose limiting toxicity (DLT), treatment-emergent adverse events (TEAEs), and changes from baseline in safety parameters [First 21 days of treatment]

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

    Secondary Outcome Measures

    1. Pharmacokinetics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab, serum concentration-time profile and PK parameters [Through study completion, up to 2,5 years]

      Maximum concentration (Cmax)

    2. Pharmacokinetics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab, serum concentration-time profile and PK parameters [Through study completion, up to 2,5 years]

      Time of maximum concentration (Tmax)

    3. Pharmacokinetics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab, serum concentration-time profile and PK parameters [Through study completion, up to 2,5 years]

      Area under the curve (AUC)

    4. Immunogenicity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab [Through study completion, up to 2,5 years]

      Incidence of anti-ADU-antibodies

    5. Pharmacodynamics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab [Through end of treatment, up to 2 years]

      DNA sequencing of SIRPα alleles

    6. Pharmacodynamics of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab [Through end of treatment, up to 2 years]

      Target engagement by ADU-1805

    7. Preliminary Clinical activity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab [Through study completion, up to 2,5 years]

      Overall response per (i)RECIST.

    8. Preliminary Clinical activity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab [Through study completion, up to 2,5 years]

      Duration of response per (i)RECIST.

    9. Preliminary Clinical activity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab [Through study completion, up to 2,5 years]

      Disease control per (i)RECIST

    10. Preliminary Clinical activity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab [Through study completion, up to 2,5 years]

      Duration of disease control per (i)RECIST

    11. Preliminary Clinical activity of ADU-1805 monotherapy and ADU-1805 plus pembrolizumab [Through study completion, up to 2,5 years]

      Progression-free survival per (i)RECIST

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Sairopa B.V.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sairopa B.V.
    ClinicalTrials.gov Identifier:
    NCT05856981
    Other Study ID Numbers:
    • SRP-22C102
    First Posted:
    May 12, 2023
    Last Update Posted:
    May 12, 2023
    Last Verified:
    May 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sairopa B.V.
    Immunotherapy
    Additional relevant MeSH terms:
    Neoplasms
    Pembrolizumab

    Study Results

    No Results Posted as of May 12, 2023