A Phase 1 interventional study of ATB-320 in Solid Tumors, sponsored by Autotelicbio. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Autotelicbio · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety and tolerability of ATB-320 in patients with progressive or metastatic solid tumors
Autotelicbio is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive ATB-320 in cycles. One cycle will consist of 4 weeks (28 days). The study will start with Cohort 1 and the progression to the next cohort will depend on the occurrence of dose limiting toxicity (DLT). The dosage regimen of the investigational product is as follows: Cohort 1: 1.0 mg/kg Cohort 2: 2.0 mg/kg Cohort 3: 4.0 mg/kg Cohort 4: 8.0 mg/kg
Drug: ATB-320
IV infusion
Dose Limiting Toxicity (DLT)
Occurrence of dose limiting toxicity (DLT) will be assessed for the DLT Analysis Set for each cohort until Cycle 1 Day 28 (C1D28) and will be discussed by the Data Monitoring Committee (DMC).
Time frame: First dose to Cycle 1 Day 28 (each cycle is 28 days)
Maximum Tolerated Dose (MTD)
The highest dose (cohort) at which no more than one out of three to six participants in a cohort experience a dose limiting toxicity (DLT).
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Safety
Number of participants with AE, with abnormal physical examination findings, abnormal vital signs, abnormal ECG readings, abnormal clinical laboratory tests results
Time frame: At the end of each cycle (each cycle is 28 days) and up to 14 days from the last dose of ATB-320
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Autotelicbio