What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, such as pegylated liposomal doxorubicin (PLD) and mirvetuximab soravtansine (MIRV), often have side effects including nausea, fatigue, anemia, and gastrointestinal issues. PLD can cause hand-foot syndrome, mucositis, and cardiotoxicity, while MIRV may lead to ocular toxicities and peripheral neuropathy. General chemotherapy side effects include hair loss, increased risk of infection, and bone marrow suppression. Targeted therapies, like PARP inhibitors, can cause nausea, vomiting, and hematologic toxicities such as anemia and neutropenia.

What prior FDA approvals exist?

The FDA has approved several treatments for ovarian cancer, particularly for cases that are platinum-resistant. Notable approvals include pegylated liposomal doxorubicin (PLD) and mirvetuximab soravtansine (MIRV), which are being studied in combination with SL-172154, a CD47/SIRPα inhibitor. These drugs are used to manage platinum-resistant ovarian cancer, offering alternative mechanisms of action to traditional platinum-based therapies. Other relevant FDA-approved treatments include PARP inhibitors like olaparib and rucaparib, which are used for maintenance therapy in platinum-sensitive recurrent ovarian cancer.

What other types of research exist?

Promising novel alternatives to SL-172154 for ovarian cancer patients include pegylated liposomal doxorubicin (PLD) and mirvetuximab soravtansine (MIRV), as they are being evaluated in combination with SL-172154 in a phase 1b trial. Additionally, immune checkpoint inhibitors like pembrolizumab and avelumab, which target PD-1 and PD-L1, respectively, may also be considered based on their mechanisms and ongoing evaluations in various cancers.

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Monoclonal Antibodies

SL-172154 Combination Therapy for Ovarian Cancer

Phase 1

Waitlist Available

Research Sponsored by Shattuck Labs, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first dose up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, SL-172154, combined with either a special chemotherapy or another drug in patients whose ovarian or related cancers don't respond to standard treatments. The goal is to find a safe dose and see how well the combination works.

Who is the study for?

This trial is for adults with high-grade ovarian, fallopian tube, or primary peritoneal cancer that's resistant to platinum-based chemotherapy. Participants must have measurable disease and be in good physical condition (ECOG PS of 0 or 1). They should not have had certain prior treatments like anti-CD47 agents and must have recovered from previous therapy side effects. Those with active infections, other cancers needing treatment, severe heart conditions, or immune diseases are excluded.

What is being tested?

The study tests SL-172154 combined with either pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients whose ovarian cancer doesn't respond to platinum drugs. The trial has two parts: finding the right dose and then seeing how well it works on a larger group.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in organs, infusion-related symptoms like fever or chills, fatigue, digestive issues including nausea and diarrhea, blood disorders which can affect cell counts leading to increased infection risk.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first dose up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first dose up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and first dose up to 3 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Establish the recommended Phase 2 dose (RP2D) for SL-172154 when administered with MIRV

Establish the recommended Phase 2 dose (RP2D) for SL-172154 when administered with PLD

Evaluate safety and tolerability of SL-172154 when administered with MIRV

+1 more

Secondary study objectives

Area under the serum concentration-time curve (AUC) of DM4 Payload

Area under the serum concentration-time curve (AUC) of MIRV

Area under the serum concentration-time curve (AUC) of S-Methyl DM4 Payload

+16 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: Pegylated Liposomal Doxorubicin + SL-172154 (SIRPα-Fc-CD40L)Experimental Treatment1 Intervention

Pegylated Liposomal Doxorubicin (PLD) will be administered via intravenous administration + SL-172154 (SIRPα-Fc-CD40L) will be administered via intravenous administration.

Group II: Mirvetuximab + SL-172154 (SIRPα-Fc-CD40L)Experimental Treatment1 Intervention

Mirvetuximab (MIRV) will be administered via intravenous administration + SL-172154 (SIRPα-Fc-CD40L) will be administered via intravenous administration

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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

Common treatments for ovarian cancer include chemotherapy agents like pegylated liposomal doxorubicin (PLD) and paclitaxel, which work by damaging the DNA of cancer cells, leading to cell death. PARP inhibitors, such as niraparib, prevent cancer cells from repairing their DNA, making them more susceptible to damage. Angiogenesis inhibitors like bevacizumab block the blood supply to tumors, inhibiting their growth. The investigational agent SL-172154, a CD47/SIRPα inhibitor, works by blocking the 'don't eat me' signal on cancer cells, allowing the immune system to recognize and destroy them. Understanding these mechanisms is crucial for ovarian cancer patients as it helps tailor treatments to target specific pathways involved in their cancer, potentially improving outcomes and reducing side effects.