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ACR-2316-101: Phase 1 study of ACR-2316 in subjects with advanced solid tumors

Primary Investigator
Zhou, Zhen Ni
Status
OPEN TO ACCRUAL
Phase
I
NCT Number
NCT06667141
UM Number
2025.003
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Multi-tumor Experimental Therapeutics
ID (Protocol)
57578
Secondary Protocol No
HUM00266479
Scope
Unspecified
Sponsor Type
Industry
Disease Site
Breast
Cervix
Colon
Corpus Uteri
Esophagus
Kidney
Larynx
Lip, Oral Cavity and Pharynx
Lung
Other Digestive Organ
Other Female Genital
Ovary
Pancreas
Prostate
Rectum
Soft Tissue
Stomach
Urinary Bladder
Summary
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.

Eligibility: Inclusion Criteria
  •   1. Signed written informed consent.
  •   2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors.
  •   3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months.
  •   4. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1.
  •   5. Adequate organ functions.
  •   6. Must have progressed after prior line of treatment.
Exclusion Criteria
  •   (all participants):
  •   1. Participants with known symptomatic brain metastases.
  •   2. Participant had systemic therapy or radiation therapy within 2 weeks prior to the first dose of study drug.
  •   3. Women who are pregnant or lactating.