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Trial Title:
Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors
NCT ID:
NCT06667141
Condition:
Specific Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
ACR-2316
WEE1
PKMYT1
Locally advanced, recurrent or metastatic solid tumors
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
Dose escalation - Evaluable participants for dose limiting toxicity (DLT), maximum
tolerated dose (MTD) determination for ACR-2316 administered per schedule A.
Dose expansion - participants with certain tumor types will be randomized 1:1 to receive1
of the 2 dose levels that will be selected for the determination of RP2D.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ACR-2316
Description:
ACR-2316 is an experimental drug
Arm group label:
Dose escalation
Arm group label:
Dose expansion
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.
Detailed description:
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 preliminary evaluation of anti-tumor activity.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Carolina BioOncology Institute
Address:
City:
Huntersville
Zip:
28078
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hannah Wall
Investigator:
Last name:
Neel Gandhi, MD
Email:
Principal Investigator
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77054
Country:
United States
Status:
Recruiting
Contact:
Last name:
CR Registration Team Office of Clinical Research
Email:
cr_study_registration@mdanderson.org
Investigator:
Last name:
Timothy A Yap, MD,PhD
Email:
Principal Investigator
Facility:
Name:
NEXT Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jordan Georg
Investigator:
Last name:
David Sommerhalder, MD
Email:
Principal Investigator
Facility:
Name:
Next Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Contact:
Last name:
Blake Patterson
Investigator:
Last name:
Mohamad Salkeni, MD
Email:
Principal Investigator
Start date:
October 8, 2024
Completion date:
December 12, 2026
Lead sponsor:
Agency:
Acrivon Therapeutics
Agency class:
Industry
Source:
Acrivon Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06667141
