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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Sairopa B.V.
Study ID
NCT05856981
Phase
PHASE1
Status
Recruiting
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Conditions

  • CRC, Colorectal Cancer
  • Endometrial Cancer
  • Metastatic Solid Tumor
  • NSCLC (Advanced Non-small Cell Lung Cancer)
  • RCC, Clear Cell Adenocarcinoma
  • Refractory Cancer
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ADU-1805 — DRUG
    anti-SIRPα monoclonal antibody
  • Pembrolizumab — DRUG
    Keytruda

Study Details

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).

Key Dates

Start date
Apr 3, 2023
Status verified
May 2025
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy dose escalation, IV, Q3W, multiple dose levels
    ADU-1805 monotherapy dose escalation
  • Experimental: Combination dose escalation, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose
    ADU-1805 plus pembrolizumab dose escalation
  • Experimental: Combination dose expansion, IV, Q3W, multiple dose levels, pembrolizumab at fixed dose
    ADU-1805 plus pembrolizumab dose expansion

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Henry Ford Cancer InstituteDetroitMichigan48202
Weise, Dr.
Washington University Medical CampusSt LouisMissouri63110
Khushman, Dr.
Gabrail Cancer & Research CenterCantonOhio44718
Gabrail, Dr.
Virginia Cancer SpecialistsFairfaxVirginia22205
Spira, Dr.

Find similar trials in Detroit, MI

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Endometrial cancer
By specialty
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By research site
Henry Ford Cancer Institute· Detroit, MIWashington University Medical Campus· St Louis, MOGabrail Cancer & Research Center· Canton, OHVirginia Cancer Specialists· Fairfax, VA

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