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

First listed
May 12, 2023
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

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
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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