Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
70 participants
INTERVENTIONAL
2025-02-05
2028-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Cohorts
ARC101 will be administered in escalating doses, with each dose escalation cohort assessing toxicity 21 days after the initial dose.
ARC101
ARC101 will be administered according to an assigned dose schedule.
Dose Expansion Cohorts
ARC101 will be administered at recommended phase 2 dose(s).
ARC101
ARC101 will be administered according to an assigned dose schedule.
Interventions
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ARC101
ARC101 will be administered according to an assigned dose schedule.
Eligibility Criteria
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Inclusion Criteria
* Measurable or evaluable disease, per RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function
Exclusion Criteria
* Malignancy diagnosis other than the disease under study within 2 years prior to the first dose of study drug.
* Presence of uncontrolled ascites
* Toxicity related to prior anticancer therapy that has not returned to Grade ≤1 or baseline levels
* Clinically significant pulmonary compromise
* Active autoimmune disease within 12 months prior to first dose of study drug.
* Female participant who is pregnant, breastfeeding, or plans to become pregnant or male participant who plans to father a child either while enrolled or within 90 days after the final administration of study drug.
18 Years
ALL
No
Sponsors
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Third Arc Bio
INDUSTRY
Responsible Party
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Locations
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START Midwest
Grand Rapids, Michigan, United States
START San Antonio, LLC.
San Antonio, Texas, United States
Sunshine Coast University Private Hospital
Birtinya, Queensland, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Cabrini Health Research
Malvern, Victoria, Australia
BC Cancer Research Centre
Vancouver, British Columbia, Canada
The Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Rambam Medical Center
Haifa, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Other Identifiers
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ARC101-P1-101
Identifier Type: -
Identifier Source: org_study_id
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