A Phase 2 Study of ACR-368 in Endometrial Adenocarcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Acrivon Therapeutics Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

14 Apr 2026 → ongoing

Decision date (initial)

2026-03-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Acrivon Therapeutics, Inc.

External identifiers

EU CT number

2025-524542-10-00

ClinicalTrials.gov

NCT05548296

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Assess the antitumor activity of ACR-368 with ULDG sensitization in endometrial cancer subjects (all-comers)

Secondary objectives 4

1. Assess safety and tolerability of ACR-368 with ULDG sensitization.
2. Assess efficacy, disease control, survival, and landmarks of survival, by CT scans and/or MRI
3. Assess efficacy, disease control by CT scan and/or MRI
4. Assess quality of life

Conditions and MedDRA coding

Endometrial cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 14

1. Subjects who are 18 years of age or older at time of consent.
2. Subject must have an estimated life expectancy of longer than 3 months in the clinical judgement of the Investigator.
3. Subject must have adequate organ function at Screening, as defined in the protocol.
4. Subject must have adequate coagulation profile as defined in the protocol.
5. Subject is willing and able to comply with clinical trial instructions and requirements.
6. Subject must be able to give signed, written informed consent.
7. Subject must have histologically documented, high-grade endometrial cancer.
8. Treatment history: Subject must have received prior platinum-based chemotherapy. Subject must have received prior anti-PD-(L)1 therapy. Subject must not have received more than two lines of any type of prior systemic therapy.
9. Subject must have histologically confirmed metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen. Confirmation of progression must be established using a set of imaging that will also be used to determine the presence of at least one measurable lesion.
10. Subject must have at least 1 measurable lesion per RECIST v1.1 criteria (by local Investigator). Subject must have radiographic evidence of disease progression based on RECIST v1.1 criteria following the most recent line of treatment.
11. Subject must be willing to provide archival tumor, either as a tissue block or at least 20 unstained slides, if available.
12. Subject must have stabilized or recovered (Grade 1 or baseline) from all prior therapy -related toxicities (except alopecia, endocrine events from prior immunotherapy and neuropathy events from prior cytotoxic therapies stabilized at ≤ Grade 2).
13. Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
14. Subject received treatment with moderate or strong inhibitors of CYP1A2 within 14 days prior to the first dose of study drug. Note: Individual cases may be discussed with the Sponsor or Medical Monitor.

Exclusion criteria 10

1. Subject with known symptomatic brain metastases requiring > 10 mg/day of prednisolone (or its equivalent). Subjects with previously diagnosed brain metastases are eligible if they have completed their treatment, have recovered from the acute effects of radiation therapy or surgery prior to the start of ACR-368 treatment, fulfill the steroid requirement for these metastases, and are neurologically stable based on central nervous system imaging ≥ 4 weeks after treatment.
2. Subject has mesenchymal tumors of the uterus.
3. Subject has a history of clinically meaningful ascites, defined as a history of paracentesis or thoracentesis with therapeutic intent, within 4 weeks of Screening. Subjects with planned therapeutic paracentesis or thoracentesis between Screening and Cycle 1 Day 1 dosing are excluded.
4. Subject had systemic therapy or radiation therapy within 3 weeks prior to the first dose of study drug.
5. Subjects has known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection that is considered uncontrolled based on the criteria included in protocol.
6. Subject has a history of clinically meaningful coagulopathy, bleeding diathesis.
7. Subject has cardiovascular disease, as defined in the protocol.
8. Subject has a history of major surgery within 4 weeks of Screening.
9. Subject has bowel obstruction related to the current cancer within the last 6 months or signs or symptoms of intestinal obstruction, which include nausea, vomiting, or objective radiologic finding of bowel obstruction in the last 4 weeks before the start of the treatment.
10. Subject has taken a prior cell cycle CHK1 inhibitor, including ACR-368.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Confirmed ORR in subjects per RECIST v1.1 by CT scan and/or MRI.

Secondary endpoints 4

1. Incidence of AEs characterized overall and by type, incidence, severity graded according to NCI CTCAE v5.0, seriousness, and relationship to study treatment. Changes in clinical laboratory parameters, vital signs, ECG parameters, and physical examination findings.
2. DOR calculated from the time of first objective response detection according to RECIST v1.1 by CT scan and/or MRI and the time of assessed progressive disease . PFS and OS based on analysis of Kaplan-Meier estimates by CT scans and/or MRI . CBR, i.e., DCR maintained for at least 4 months, by CT scans and/or MRI. Progression-free rate at 6 months and OS at 6, 9, and 12 months, by CT scans and/or MRI.
3. Confirmed ORR in subjects per RECIST v1.1 by CT scans and/or MRI. DOR calculated from the time of first objective response detection according to RECIST v1.1 by CT scan and/or MRI and the time of assessed progressive disease . CBR, i.e., DCR maintained for at least 4 months, by CT scans and/or MRI. PFS based on analysis of Kaplan-Meier estimates.
4. Change from Baseline in NRS and FACIT questionnaire scores.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Acrivon Therapeutics Inc.

Sponsor organisation

Acrivon Therapeutics Inc.

Address

480 Arsenal Way Suite 100

City

Watertown

Postcode

02472-2895

Country

United States

Scientific contact point

Organisation

Acrivon Therapeutics Inc.

Contact name

ACR-Clinical Trial Inbox

Public contact point

Organisation

Acrivon Therapeutics Inc.

Contact name

ACR-Clinical Trial Inbox

Third parties 4

Locations

4 EU/EEA countries · 21 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 19 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications