What side effects are associated with this type of intervention?

Common treatments for bladder cancer, such as chemotherapy, radiation therapy, and immunotherapy, have several known side effects. Chemotherapy can cause neutropenic sepsis, nausea, vomiting, and increased risk of infections. Radiation therapy may lead to bladder compliance issues, increased bladder sensation, and bowel dysfunction, including diarrhea and fecal urgency. Immunotherapy can result in immune-related adverse effects such as fatigue, skin reactions, and gastrointestinal symptoms. These side effects highlight the importance of supportive care and monitoring during treatment.

What prior FDA approvals exist?

Several FDA-approved treatments for bladder cancer include monotherapies and combination therapies. Gemcitabine, often used in combination with cisplatin, is a standard treatment for advanced urothelial carcinoma. Additionally, immune checkpoint inhibitors like pembrolizumab and atezolizumab have been approved for patients with advanced or metastatic urothelial carcinoma, particularly those who are ineligible for cisplatin-based chemotherapy. Enfortumab vedotin, an antibody-drug conjugate, is another approved treatment for patients who have previously received platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor.

What other types of research exist?

Promising novel alternatives to ACR-368 for bladder cancer patients include: <ol> <li>Enfortumab Vedotin: An antibody-drug conjugate targeting Nectin-4, showing efficacy in patients previously treated with platinum and PD-1/PD-L1 inhibitors.</li> <li></li> </ol> Erdafitinib: An FGFR inhibitor effective in patients with FGFR genetic alterations. 3. Pembrolizumab: A PD-1 inhibitor used as first-line therapy in cisplatin-ineligible patients and showing long-term efficacy. 4. Atezolizumab: A PD-L1 inhibitor used in cisplatin-ineligible patients with advanced urothelial carcinoma.

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ACR-368 for Ovarian Cancer

Phase 1 & 2

Recruiting

Led By Jonathan Rosenberg, 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.

Must not have

Participants has known human immunodeficiency virus, hepatitis B, or hepatitis C infection that is considered uncontrolled.

Tumor specific exclusion criteria for Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up response will be assessed every 8 weeks from baseline through 2 years or death.

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have an uncontrolled HIV, hepatitis B, or hepatitis C infection.

Select...

My cancer type is not excluded by the study.

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I have previously taken a CHK1 inhibitor medication.

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I have heart disease.

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I have a history of significant bleeding or clotting disorders.

Select...

I need more than 10 mg/day of prednisolone for my brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ response will be assessed every 8 weeks from baseline through 2 years or death.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Arm 1: Adverse Events (AEs) for ACR-368 monotherapy

Arm 1: Limited pharmacokinetic (PK) testing in participants with Ovarian Carcinoma

Pain Threshold

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 NegativeExperimental 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. A Phase 2 Exploratory Study will 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

~1920

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for bladder cancer include chemotherapy, radiation therapy, and immunotherapy. Chemotherapy, such as cisplatin-based regimens, works by damaging the DNA of cancer cells, preventing them from dividing and growing. Radiation therapy uses high-energy rays to kill cancer cells or slow their growth by damaging their DNA. Immunotherapy, including agents like BCG and checkpoint inhibitors (e.g., atezolizumab, pembrolizumab), enhances the body's immune response against cancer cells. These treatments are crucial for bladder cancer patients as they offer multiple avenues to target and destroy cancer cells, potentially improving survival rates and quality of life. The trial ACR-368, which includes ultralow dose gemcitabine, a chemotherapy agent, aims to explore new combinations to enhance efficacy and reduce side effects.

[Mechanism of action of intravesical BCG. Biological bases and clinical applicability.][The role of immunotherapy in the modern treatment of urothelial carcinoma].Emerging drugs for urothelial carcinoma.