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Evaluation of Safety and Tolerability of ATB-320 in Participants With Progressive or Metastatic Solid Tumors

ConditionSolid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAutotelicbio

About this trial

The purpose of this study is to evaluate the safety and tolerability of ATB-320 in patients with progressive or metastatic solid tumors

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ATB-320

    Drug

    IV infusion

Treatment groups

24 Participants
are divided into 1 treatment group
Group A: ATB-320Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)
2

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)

Secondary outcomes

1

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Autotelicbio

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: