Status:
NOT_YET_RECRUITING
Evaluation of Safety and Tolerability of ATB-320 in Participants With Progressive or Metastatic Solid Tumors
Lead Sponsor:
Autotelicbio
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of ATB-320 in patients with progressive or metastatic solid tumors
Detailed Description
1. Primary objective: to evaluate the maximum tolerable dose (MTD), recommended phase 2 dose (RP2D), and dose limiting toxicities (DLTs) of ATB-320 in patients with progressive or metastatic solid tum...
Eligibility Criteria
Inclusion
- Adult (18 years or older) at the time of screening
- Histologically confirmed solid tumor
- Participants must have failed standard therapy or cannot tolerate standard therapy.
- Participants must be able to provide tissue samples, either stored at the institution or obtained from a biopsy performed prior to administration of the investigational product, and have tumor that can be safely biopsied throughout the study.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Life expectancy of ≥ 12 weeks
Exclusion
- Has received chemotherapy within 21 days prior to the first planned dose of the investigational product, or if less than 5 times the half-life of the chemotherapeutic has passed (whichever is shorter)
- Has received immunotherapy within 2 weeks of the first planned dose of investigational product
- Major surgery within 4 weeks prior to the first planned dose of the investigational product
- Previous malignant tumors, other than the target indication to be investigated in this study, within 3 years prior to screening (participants with locally malignant tumors such as basal cell carcinoma/squamous cell carcinoma of the skin, carcinoma in situ (cervix, breast), thyroid papillary carcinoma that have undergone potentially curative therapy are eligible to participate in the study.
- Current enrollment in any other clinical trial or has received another investigational product or medical device treatment within 28 days of first planned dose (participants who are undergoing safety follow-up phase of a clinical trial may participate if more than 28 days have passed since the last dose of the previous investigational product)
- Has received prior radiotherapy within 2 weeks of the first planned dose. Participants who have received palliative radiotherapy for non-central nervous system (CNS) disease within 2 weeks of first planned dose are allowed to participate after 1-week washout (participants must have recovered from any radiation-related toxicities, not require corticosteroid treatment, and without radiation pneumonitis)
- History of hypersensitivity to the active ingredients or excipients of the investigational product or other drugs
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06933524
Start Date
December 1 2025
End Date
December 1 2028
Last Update
October 1 2025
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