What side effects are associated with this type of intervention?

Common treatments for solid tumors, including targeted therapies like kinase inhibitors and traditional chemotherapeutic agents, often result in a range of side effects. These can include gastrointestinal issues such as nausea, vomiting, and diarrhea; hematologic toxicities like neutropenia, anemia, and thrombocytopenia; and other systemic effects such as fatigue, neuropathy, and alopecia. Targeted therapies may also cause specific side effects related to their mechanism of action, such as skin rashes and hypertension.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of solid tumors, including tyrosine kinase inhibitors (TKIs) and immune checkpoint inhibitors. Examples include pembrolizumab, a PD-1 inhibitor, and eribulin, a microtubule dynamics inhibitor. While specific FDA approvals for ACSS2 enzyme inhibitors like MTB-9655 are not mentioned, the development of such targeted therapies represents a growing area of interest in oncology, aiming to inhibit specific metabolic pathways crucial for tumor growth.

What other types of research exist?

Promising alternatives to MTB-9655 for solid tumor patients include AZD4625, a potent and selective inhibitor of KRASG12C, and DS-6051b, a selective ROS1/NTRK inhibitor effective against crizotinib-resistant ROS1 positive cancers. Both have shown significant efficacy in preclinical models and are potential candidates for treatment in 2024.

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Anti-metabolites

MTB-9655 for Solid Tumors

Phase 1

Waitlist Available

Research Sponsored by MetaboMed 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 every 6 weeks from cycle 1 day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new pill called MTB-9655 for patients with advanced cancers that don't respond to other treatments. The pill works by blocking an enzyme that helps cancer cells grow.

Who is the study for?

Adults with advanced solid tumors that are locally advanced, unresectable/metastatic, and have not responded to standard treatments or have no standard treatment options. Participants must be in good physical condition (ECOG score of 0 or 1), able to provide a tumor sample, expected to live at least 3 months, and use effective contraception if applicable.

What is being tested?

MTB-9655 is being tested as an oral cancer treatment targeting the ACSS2 enzyme. This Phase 1 trial involves up to 30 patients taking varying doses to find the safest and most effective level. It's open-label so everyone knows they're getting MTB-9655, and it includes dose escalation.

What are the potential side effects?

Specific side effects for MTB-9655 aren't listed but may include typical reactions seen with cancer medications such as nausea, fatigue, blood count changes, liver function alterations, digestive issues or allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 weeks from cycle 1 day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 weeks from cycle 1 day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks from cycle 1 day 1 for 24 weeks, then every 12 weeks until disease progression or death or up to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants with adverse events following administration of MTB-9655

Part A: Number of participants with dose limiting toxicities (DLTs) from MTB-9655 monotherapy in patients with locally advanced or metastatic solid tumors.

Recommended Phase 2 dose (RP2D) of MTB-9655 monotherapy in patients with locally advanced or metastatic solid tumors.

Secondary study objectives

Disease control rate based on RECIST 1.1

Duration of response based on RECIST 1.1

Overall response rate in participants receiving MTB-9655

+3 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Part A Dose-Escalation and Part B RP2D Dose-ExpansionExperimental Treatment1 Intervention

Study has two parts: 1. Part A Dose-Escalation will evaluate MTB-9655 monotherapy administered in 21 days cycle,and will be conducted in 2 stages (accelerated titration and dose-escalation). The first stage will consist of accelerated titration in single-patient cohorts for the initial two dose levels. In the second stage, a conventional 3+3 schema using a modified Fibonacci dose titration strategy will be implemented. The first dose at every dose level and in every patient will be administered under close medical supervision, and the patients will be hospitalized for approximately 24 hours. Up to 30 participants will participate in this dose escalation arm. 2. Part B dose-expansion will further explore the safety, PK and preliminary efficacy of MTB-9655 at the RP2D. The RP2D level will be no higher than the MTD identified in Part A.

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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 solid tumors often target specific enzymes and pathways essential for cancer cell survival and proliferation. For instance, the inhibition of the ACSS2 enzyme, as seen with MTB-9655, disrupts the cancer cells' ability to synthesize acetyl-CoA, a molecule crucial for energy production and lipid synthesis. This can starve the tumor cells and inhibit their growth. Similarly, tyrosine kinase inhibitors block signaling pathways that promote cell division and survival, while PARP inhibitors prevent DNA repair in cancer cells, leading to cell death. These targeted therapies are significant for solid tumor patients as they offer a more precise approach to treatment, potentially reducing side effects and improving outcomes by directly attacking the cancer cells' vulnerabilities.

PARP Inhibitor Activity Correlates with SLFN11 Expression and Demonstrates Synergy with Temozolomide in Small Cell Lung Cancer.Treatment options for relapsed small-cell lung cancer.