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Not yet recruitingNCT06933524ATB-320-001AUpdated Oct 1, 2025

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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

Read the 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 tumors.
  2. Secondary objective: to evaluate safety and tolerability of ATB-320 in patients with progressive or metastatic solid tumors.
  3. Exploratory objective: to evaluate pharmacokinetics, pharmacodynamics, and efficacy of ATB-320 in patients with progressive or metastatic solid tumors.
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Conditions studied

  • Solid Tumors
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In context

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adult (18 years or older) at the time of screening
  2. Histologically confirmed solid tumor
  3. Participants must have failed standard therapy or cannot tolerate standard therapy.
  4. 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.
  5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
  6. Life expectancy of ≥ 12 weeks

Exclusion criteria

Exclusion Criteria:

  1. 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)
  2. Has received immunotherapy within 2 weeks of the first planned dose of investigational product
  3. Major surgery within 4 weeks prior to the first planned dose of the investigational product
  4. 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.
  5. 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)
  6. 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)
  7. History of hypersensitivity to the active ingredients or excipients of the investigational product or other drugs
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    ATB-320

    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

Interventions

  • DrugATB-320

    IV infusion

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What researchers measure

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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06933524
Lead sponsor
Autotelicbio
Responsible party
Sponsor
First posted
Apr 18, 2025
Start date
Dec 1, 2025 (estimated)
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 1, 2028 (estimated)
Last update
Oct 1, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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