An Open-Label, Multicenter, Multi-arm Phase I Study Evaluating the Safety and Pharmacokinetics of ADU-1805 in Adults With Advanced Solid Tumors
Study Identifier:
SRP-22C102
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
To evaluate the safety and pharmacokinetics of ADU-1805 as a single agent and in a combination regimen in patients with multiple tumor types, including adults with advanced solid tumors
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Solid Tumor
Unspecified Cancer
Bowel (Colorectal)
Renal
Female genital organs
Non-Small Cell Lung Cancer
Endometrial
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Patients will receive ADU-1805. Single Agent Dose Escalation Cohort (n~30) Complete Single Agent Expansion Cohort (n~20) in Solid Tumors Complete Dose Escalation ADU-1805 + pembrolizumab Combination Cohort Complete Dose Expansion ADU-1805 + pembrolizumab Combination Cohort (n~60) Simon’s 2-stage Experimental: Monotherapy dose escalation, IV, Q3W, multiple dose levels ADU-1805 monotherapy dose escalation Drug: ADU-1805 anti-SIRP 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-SIRP monoclonal antibody Drug: Pembrolizumab
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- Male or female aged ≥18 yearsSigned and dated informed consent formMeasurable disease according to RECIST (Safety Expansion only)ECOG Performance status of 0 or 1Adequate organ and marrow functionEscalation 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 existsExpansion 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
Exclusion criteria
- Escalation Phase: Patients that suffer from melanoma, brain tumors, glioblastoma, sarcoma and pancreatic ductal adenocarcinoma (PDAC)Expansion Phase:> 3 lines of prior systemic treatmentsMSS colorectal cancer (CRC): liver metastasis presentPregnancy or breast-feedingPrior treatment with or receipt of:biological agents, including monoclonal antibodies and immunotherapies, within 28 days prior to the first dose of ADU-1805chemotherapy, 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 therapysystemic chronic steroid therapy or immunosuppressive therapy within 14 days prior to the first dose of ADU-1805other investigational new drug or investigational device within 28 days prior to the first dose of ADU-1805vaccine containing live virus within 28 prior to the first dose of ADU-1805Active untreated brain metastasesActive infection requiring systemic therapyImpaired cardiac function or clinically significant cardiac diseaseCurrent Grade >2 toxicity related to prior anti-cancer therapyHistory of drug-induced severe immune-related adverse reactionPrior severe hypersensitivity to other monoclonal antibodies or ADU-1805 excipientsMajor surgery within defined periodDiagnosis or positive test of HIV, hepatitis B, hepatitis C, or active tuberculosisAllogenic tissue/solid organ transplantAny 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
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START La Rioja
Logroño, La Rioja, Spain, 26006
Investigator
Status
Will Be Recruiting
Condition(s) Treated at Site
Solid Tumor
Unspecified Cancer
Bowel (Colorectal)
Renal
Female genital organs
Non-Small Cell Lung Cancer
Endometrial
Location
START Mountain Region
West Valley City, UT, United States, 84119
Investigator
William McKean
Status
Recruiting
Condition(s) Treated at Site
Solid Tumor
Unspecified Cancer
Bowel (Colorectal)
Renal
Female genital organs
Non-Small Cell Lung Cancer
Endometrial