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NCT Number: NCT06667141

Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors

This is a first in-human, Open-label Phase 1 study to assess the safety of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.

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Key information

Conditions

Specific Advanced Solid Tumors Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

HonorHealth Research Institute, Phoenix, Arizona, United States

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About this study

The Phase 1 monotherapy clinical trial for ACR-2316 is designed to assess the safety and tolerability of ACR-2316. Additional objectives include the determination of the maximal tolerated dose and recommended Phase 2 monotherapy dose, characterization of the pharmacokinetic profile and pharmacogenomics, and preliminary evaluation of anti-tumor activity.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed written informed consent.
  • Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
  • Must be willing to provide redacted pathology report.
  • Subjects should have received no more than 3 lines of systemic therapy for recurrent disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
  • Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
  • Adequate organ functions.
  • Must have progressed after prior line of treatment.

Exclusion criteria

(all participants):

  • Participants with known symptomatic brain metastases.
  • Participant had systemic therapy within 3 weeks prior to the first dose of study drug.
  • Participant had radiation therapy for curative intent within 4 weeks prior to the first dose of study drug.
  • Participant had palliative radiation therapy within 2 weeks prior to the first dose of study drug.
  • Women who are pregnant or lactating.

Treatment and study plan

ACR-2316

Drug

ACR-2316 is an experimental drug

Primary outcomes

  1. Dose Escalation

    Time frame: Number of DLT events during the DLT observation period (up to 28 days)

    To determine the MTD of ACR-2316.

  2. Dose Expansion

    Time frame: RP2D supported by safety, PK, PD, and emerging clinical activity data through study completion, an average of 1 year.

    To determine the RP2D of ACR-2316.

  3. Dose Expansion

    Time frame: Incidence and grades of TEAEs and TRAEs per NCI CTCAE v.5.0 and number of dose decreases, number of dose delays, and SAEs through study completion, an average of 1 year.

    To assess the safety and tolerability of ACR-2316

  4. Dose Expansion

    Time frame: Confirmed ORR per Recist v1.1 and DOR, CBR, assessed every 6 weeks from baseline thorough study completion, an average 1 year or until death.

    To determine preliminary anti-tumor activity of ACR-2316.

Secondary outcomes

  1. Dose Escalation

    Time frame: This will be evaluated through study completion, an average of 1 year.

    To assess the safety and tolerability of ACR-2316. Safety will be assessed by the incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment.

  2. Dose Escalation

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).

  3. Dose Escalation

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).

  4. Dose Escalation

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).

  5. Dose Escalation

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).

  6. Dose Escalation

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).

  7. Dose Escalation

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).

  8. Dose Escalation

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: apparent volume of distribution (Vz/F).

  9. Dose Escalation

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: terminal elimination half-life (t½).

  10. Dose Escalation

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: apparent oral clearance (CL/F).

  11. Dose Expansion

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: maximum plasma drug concentration (Cmax).

  12. Dose Expansion

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: minimum plasma drug concentration (Cmin).

  13. Dose Expansion

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: time to maximum plasma drug concentration (tmax).

  14. Dose Expansion

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: time of last quantifiable plasma drug concentration (tlast).

  15. Dose Expansion

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: area under the plasma concentration versus time curve (AUC).

  16. Dose Expansion

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: plasma drug concentration at 24 hours post-dose (C24).

  17. Dose Expansion

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: apparent volume of distribution (Vz/F).

  18. Dose Expansion

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: terminal elimination half-life (t½).

  19. Dose Expansion

    Time frame: Pharmacokinetic (PK) testing in Cycle 1, 2 & 3 (each cycle is up to 28 days). Predose and multiple time points after dose up to Cycle 3.

    To assess Pharmacokinetics: apparent oral clearance (CL/F).

Study contacts

Contact information is provided by the study sponsor or research team.

Jeanie Tang

CONTACT

[email protected]

Mansoor R Mirza, MD

CONTACT

[email protected]

617-207-8979

Sponsors and collaborators

Lead sponsor

Acrivon Therapeutics

Industry

Registry information

Official study title

ACR-2316-101: Phase 1 Study of ACR-2316 in Subjects With Advanced Solid Tumors

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 31, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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