NCT05548296 · Acrivon Therapeutics
A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma
What this study is about
This is an open label Phase 2 study to evaluate the effectiveness and safety of ACR-368 as treatment given alone or with ultra-low dose gemcitabine (ULDG) sensitization in participants with endometrial cancer.
View original scientific description
This is an open label Phase 2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or with ultra-low dose gemcitabine (ULDG) sensitization in participants with endometrial cancer.
Interventions
DRUG
ACR-368
ACR-368 is an experimental drug
DRUG
Gemcitabine
Sensitization of tumor cells is provided through administration of ULDG
DIAGNOSTIC_TEST
OncoSignature
Prospective prediction of drug sensitivity based on a pretreatment tumor biopsy
Primary outcome measures
Arm 1: Anti-tumor activity of ACR-368 in Endometrial cancer subjects that are OncoSignature Positive.
Time frame: Response will be assessed every 8 weeks from baseline through 2 years or death.
Assess Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.
Arm 2: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects that are OncoSignature Negative.
Time frame: Response will be assessed every 8 weeks from baseline through 2 years or death.
Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.
Arm 3: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers).
Time frame: Response will be assessed every 8 weeks from baseline through 2 years or death.
Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic resonance imaging.
Arm 4: Anti-tumor activity of ACR-368 with ULDG sensitization in Endometrial cancer subjects (Serous All-Comers).
Time frame: Response will be assessed every 8 weeks from baseline through 2 years or death.
Objective Response Rate (ORR) per RECIST v1.1 by computed tomography or magnetic
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- General 1. Participant must be able to give signed, written informed consent. 2. Participant must have histologically documented, high-grade endometrial cancer. 3. Treatment History Requirements: 1. Subject must have received prior platinum-based chemotherapy 2. Subject must have received prior anti-PD-(L)1 therapy 4. Participant must have histologically confirmed metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen. 5. Participant must have at least 1 measurable lesion per RECIST v1.1 criteria (by local Investigator) in a baseline tumor imaging that has been obtained within 28 days of the treatment start. Participant must have radiographic evidence of disease progression based on RECIST v1.1 criteria following the most recent line of treatment. 6. Arm 1 and 2 only: Participant must be willing to provide tissue from a newly obtained tumor biopsy from an accessible tumor lesion not previously irradiated after written info
Where
- Mobile, Alabama
- Anchorage, Alaska
- Phoenix, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Duarte, California
- La Jolla, California
- Los Angeles, California
- Newport Beach, California
- Orange, California
- Palo Alto, California
- Sacramento, California
And 47 more locations — see the full list below.
Collaborators
GOG Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations