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ACR-368 for Ovarian Cancer

Phase 1 & 2
Recruiting
Led By Jung-Min Lee, MD
Research Sponsored by Acrivon Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must have radiographic evidence of disease progression based on RECIST criteria following the most recent line of treatment. Biochemical recurrence only is not considered as disease progression.
Participant must have histologically confirmed, locally advanced or metastatic cancer that has progressed during or after at least 1 prior therapeutic regimen.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up response will be assessed every 8 weeks from baseline through 2 years or death.
Awards & highlights

Study Summary

This trial is testing a new drug for ovarian, endometrial, and urothelial cancers to see if it is effective and safe. The trial will test the drug alone and in combination with another drug.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not specified here, typical side effects may include reactions at the infusion site, fatigue, nausea, lowered blood counts leading to increased infection risk or bleeding tendencies. Organ-specific inflammation could also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My latest scans show my cancer has grown despite treatment.
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My advanced cancer has worsened despite previous treatment.
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I agree to provide a new biopsy sample from a tumor that hasn't been treated with radiation.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~response will be assessed every 8 weeks from baseline through 2 years or death.
This trial's timeline: 3 weeks for screening, Varies for treatment, and response will be assessed every 8 weeks from baseline through 2 years or death. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Endometrium
Arm 2 Exploratory Phase 2: Anti-tumor activity of ACR-368 plus ULDG in Ovarian, Endometrial and Urothelial Cohorts
Arm 2 Phase 1b: Adverse Events (AEs) for ACR-368 in combination with ULDG
+1 more
Secondary outcome measures
Arm 1: Adverse Events (AEs) for ACR-368 monotherapy
Arm 1: Limited pharmacokinetic (PK) testing in participants with Ovarian Carcinoma
Pain Threshold
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: OncoSignature Positive TumorsExperimental Treatment2 Interventions
In Arm 1, participants with an OncoSignature Positive test will enter a Phase 2 Simon 2-Stage Study that will assess the efficacy of ACR-368 as monotherapy in each of the 3 cohorts of participants (ovarian, endometrial, and urothelial).
Group II: OncoSignature Negative or Unevaluable testExperimental Treatment3 Interventions
In Arm 2, participants with an OncoSignature Negative will receive the combination of ACR-368 and ultralow Dose Gemcitabine (ULDG). The Phase 1b/2 portion will only enroll participants with OncoSignature Negative tumors. Unevaluable tumors will not be able to participate. A Phase 1b Study will assess the safety of the combination of ACR-368 and escalating doses of ULDG in participants with any of the 3 tumor types (ovarian, endometrial, and urothelial). The Phase 1b Study will determine the recommended Phase 2 dose (RP2D) of ULDG. When determined, a Phase 2 Exploratory Study will be initiated to assess the efficacy and safety of the combination of ACR-368 and the RP2D of ULDG in each of the 3 cohorts of participants (ovarian, endometrial, and urothelial).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

GOG FoundationNETWORK
42 Previous Clinical Trials
16,351 Total Patients Enrolled
Acrivon TherapeuticsLead Sponsor
Jung-Min Lee, MDPrincipal InvestigatorNational Cancer Institute (NCI)

Media Library

ACR-368 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05548296 — Phase 1 & 2
Bladder Cancer Research Study Groups: OncoSignature Negative or Unevaluable test, OncoSignature Positive Tumors
Bladder Cancer Clinical Trial 2023: ACR-368 Highlights & Side Effects. Trial Name: NCT05548296 — Phase 1 & 2
ACR-368 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05548296 — Phase 1 & 2
Bladder Cancer Patient Testimony for trial: Trial Name: NCT05548296 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the purpose of this clinical trial?

"According to the pharmaceutical company sponsoring the trial, Acrivon Therapeutics, the primary outcome being measured is Arm 1 Monotherapy: Anti-tumor activity of ACR-368 in Ovarian, Endometrial, and Urothelial Cohorts. This will be assessed every 8 weeks over a Response interval from baseline through 2 years or death. In addition to the primary outcome, this trial will also be evaluating secondary outcomes including Relative dose intensity of ACR-368 (defined as Assess the ratio of cumulative administered dose to the planned dose for first 2 cycles), Arm 1: Number of subjects with confirmed On"

Answered by AI

Can new participants still join this research project?

"According to the latest update on clinicaltrials.gov, this trial is still recruiting patients. The initial posting date was 8/29/2022 with the most recent edit on 11/15/2022."

Answered by AI

How many participants are being enrolled in this study?

"The information available on clinicaltrials.gov confirms that this trial is currently recruiting participants. The trial was originally posted on 8/29/2022 and was last updated on 11/15/2022. The trial is admitting 333 participants between 3 sites."

Answered by AI

Who else is applying?

What site did they apply to?
Yale Cancer Center
Women & Infants Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

Tried Taxol/Carboplatin with Avastin. For maintenance I tried Lynparza but stopped it due to side effects.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study of ACR-368 in Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma
2022. "A Study of ACR-368 in Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05548296.
All > Toronto > Uterine Cancer
~224 spots leftby Jul 2026
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