353 Participants Needed

ACR-368 for Ovarian Cancer

Recruiting at 60 trial locations
DL
JT
EG
JC
MM
MP
MR
SP
Overseen BySubarna Paul
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Acrivon Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, ACR-368, alone or with a small dose of another drug, gemcitabine, in patients whose cancers don't respond to standard treatments. A special test helps decide which treatment might work best for each patient. Gemcitabine has been used with other drugs for various cancers, including pancreatic, lung, ovarian, and breast cancers.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have had systemic therapy or radiation therapy within 2 weeks prior to the first dose of the study drug, which might imply a need to pause certain treatments. Please consult with the trial coordinators for specific guidance.

What safety data is available for ACR-368 (Prexasertib) in humans?

Prexasertib (also known as ACR-368) has been tested in clinical trials for ovarian cancer and other solid tumors, showing a moderate safety profile with some hematological toxicity (effects on blood cells). It has been generally well-tolerated in phase I and II trials, but further studies are needed to confirm its safety when used in combination with other treatments.12345

What makes the drug ACR-368 (Prexasertib) unique for treating ovarian cancer?

ACR-368 (Prexasertib) is unique because it is a novel checkpoint kinase inhibitor that targets cell cycle checkpoints, specifically CHK1 and CHK2, which can help improve clinical response in high-grade serous ovarian cancer, especially in cases resistant to standard platinum-based chemotherapy.12356

What data supports the effectiveness of the drug ACR-368 (Prexasertib) for ovarian cancer?

Research shows that Prexasertib, a part of ACR-368, has shown promising results in early trials for treating high-grade serous ovarian cancer, especially in patients without BRCA mutations. It has demonstrated clinical activity and a better tolerability profile compared to similar drugs.12357

Who Is on the Research Team?

PK

Panagiotis Konstantinopoulos, MD

Principal Investigator

Dana-Farber Cancer Institute (DFCI)

JL

Jung-Min Lee, MD

Principal Investigator

National Cancer Institute (NCI)

Are You a Good Fit for This Trial?

This trial is for adults with certain advanced cancers (ovarian, endometrial adenocarcinoma, or urothelial carcinoma) that have worsened after treatment. They must be able to consent, provide tumor samples, expect to live more than 3 months, have good organ function and performance status, and recovered from previous treatments' side effects.

Inclusion Criteria

Participant must have an estimated life expectancy of longer than 3 months.
My organs are functioning well.
I have recovered from side effects of previous treatments, except for some conditions.
See 8 more

Exclusion Criteria

I have an uncontrolled HIV, hepatitis B, or hepatitis C infection.
My cancer type is not excluded by the study.
I have previously taken a CHK1 inhibitor medication.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ACR-368 as monotherapy or in combination with ultralow dose gemcitabine based on OncoSignature status

Until disease progression or unacceptable toxicity

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Pharmacokinetic Testing

Limited PK testing of ACR-368 in combination with ULDG in Arm 2 and monotherapy in Arm 1

First cycle
Day 1 and Day 15 of first cycle

What Are the Treatments Tested in This Trial?

Interventions

  • ACR-368
  • Gemcitabine
Trial Overview The study tests ACR-368 alone or with very low doses of Gemcitabine in patients selected by the OncoSignature test. It's an early-phase trial assessing how well these treatments work and their safety in participants with specific resistant cancers.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: OncoSignature Unselected (All-Comers)Experimental Treatment2 Interventions
Group II: OncoSignature Positive TumorsExperimental Treatment2 Interventions
Group III: OncoSignature Negative TumorsExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Acrivon Therapeutics

Lead Sponsor

Trials
3
Recruited
520+

GOG Foundation

Collaborator

Trials
48
Recruited
18,500+

Published Research Related to This Trial

Prexasertib, a novel checkpoint kinase inhibitor, has shown promising efficacy and safety in treating high-grade serous ovarian cancer (HGSOC) in phase II trials, particularly for patients with wild-type BRCA, indicating it could be a valuable treatment option.
Compared to other similar drugs, prexasertib has a better tolerability profile with moderate hematological toxicity, suggesting it may be safer for patients, although further studies are needed to confirm its efficacy and safety in combination therapies.
Prexasertib: an investigational checkpoint kinase inhibitor for the treatment of high-grade serous ovarian cancer.Evangelisti, G., Barra, F., Moioli, M., et al.[2021]
In a phase 2 study involving 28 women with BRCA wild-type high-grade serous ovarian carcinoma, prexasertib demonstrated clinical activity, with 29% of patients showing partial responses, indicating its potential efficacy in this difficult-to-treat population.
The treatment was generally tolerable, although it caused significant side effects like neutropenia in 93% of patients, which was mostly transient and resolved without additional support, suggesting that while effective, careful monitoring for adverse effects is necessary.
Prexasertib, a cell cycle checkpoint kinase 1 and 2 inhibitor, in BRCA wild-type recurrent high-grade serous ovarian cancer: a first-in-class proof-of-concept phase 2 study.Lee, JM., Nair, J., Zimmer, A., et al.[2021]
In a Phase 2 trial involving 169 patients with high-grade serous ovarian cancer, prexasertib showed a 12.1% objective response rate in platinum-resistant patients, indicating some effectiveness in this difficult-to-treat population.
The treatment was associated with common side effects such as thrombocytopenia and neutropenia, but it demonstrated durable activity regardless of BRCA status or previous therapies, highlighting the need for better biomarkers to identify which patients might benefit most.
A Phase 2 study of prexasertib (LY2606368) in platinum resistant or refractory recurrent ovarian cancer.Konstantinopoulos, PA., Lee, JM., Gao, B., et al.[2023]

Citations

Prexasertib: an investigational checkpoint kinase inhibitor for the treatment of high-grade serous ovarian cancer. [2021]
Prexasertib, a cell cycle checkpoint kinase 1 and 2 inhibitor, in BRCA wild-type recurrent high-grade serous ovarian cancer: a first-in-class proof-of-concept phase 2 study. [2021]
A Phase 2 study of prexasertib (LY2606368) in platinum resistant or refractory recurrent ovarian cancer. [2023]
EPIK-O/ENGOT-OV61: alpelisib plus olaparib vs cytotoxic chemotherapy in high-grade serous ovarian cancer (phase III study). [2022]
A phase 1 study of prexasertib (LY2606368), a CHK1/2 inhibitor, in pediatric patients with recurrent or refractory solid tumors, including CNS tumors: A report from the Children's Oncology Group Pediatric Early Phase Clinical Trials Network (ADVL1515). [2022]
The CHK1 Inhibitor Prexasertib Exhibits Monotherapy Activity in High-Grade Serous Ovarian Cancer Models and Sensitizes to PARP Inhibition. [2022]
Broad Spectrum Activity of the Checkpoint Kinase 1 Inhibitor Prexasertib as a Single Agent or Chemopotentiator Across a Range of Preclinical Pediatric Tumor Models. [2020]
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