NM32-2668 for Advanced Cancer

No longer recruiting at 10 trial locations

Overseen By Dale Shepard

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Numab Therapeutics AG

Must not be taking: ROR1 agents, CD3 therapies

Disqualifiers: CAR therapy, Recent radiotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NM32-2668 for individuals with certain advanced solid tumors, which are cancers forming in solid organs. Researchers aim to assess the treatment's safety, how the body processes it, and its effectiveness against cancer. They seek participants whose tumors exhibit a specific marker called ROR1 and who have exhausted other treatments due to ineffectiveness or intolerance. This trial may suit patients who have no remaining standard treatment options. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial requires that you stop any systemic anti-cancer treatments at least 21 days or five half-lives before starting the study drug, whichever is shorter. If you have had certain types of radiation therapy, you may also need to wait a specific period before joining the trial.

Is there any evidence suggesting that NM32-2668 is likely to be safe for humans?

Research has shown that NM32-2668 appears safe based on early studies. Tests on animals, such as monkeys, suggest that this treatment works well and is tolerated without major issues. While these results are promising, this trial marks the first time NM32-2668 is tested in humans. The study's main goal is to assess the treatment's safety and observe human reactions. Participants in this trial will help determine the best dose for future studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced cancer, which often include chemotherapy and targeted therapies, NM32-2668 is unique because it operates on a novel mechanism of action. Researchers are excited about NM32-2668 because it specifically targets a new pathway in cancer cells that hasn't been exploited by existing therapies, potentially leading to more effective treatment outcomes. Additionally, NM32-2668 might offer a more favorable side effect profile, making it a promising option for patients seeking alternatives to traditional treatments.

What evidence suggests that NM32-2668 might be an effective treatment for advanced cancer?

Research has shown that NM32-2668, the treatment under study in this trial, has yielded promising results from early tests. Animal studies demonstrated its effectiveness and safety. In lab experiments, NM32-2668 successfully eliminated tumors in a model of mantle cell lymphoma. This treatment employs advanced technology to enhance the immune system's ability to fight cancer. Although information from human studies remains limited, these early findings suggest NM32-2668 might be effective against advanced solid tumors. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Adults with certain advanced solid tumors, including various cancers like endometrial, melanoma, ovarian, kidney, breast cancer and more. Participants must meet specific health criteria to join.

Inclusion Criteria

My cancer has worsened after treatment and I can't undergo standard therapy.

My cancer is advanced and has been confirmed by a biopsy.

My tumor tests positive for ROR1 expression.

Exclusion Criteria

I haven't had cancer treatment within the last 21 days or five half-lives of the drug, whichever is shorter.

I have not been treated with drugs targeting ROR1 or CD3 T-cell therapies before.

I have not had CAR cell therapy in the last 90 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Participants receive NM32-2668 to evaluate safety, immunogenicity, and determine the maximal tolerated dose

8-12 weeks

Expansion Cohorts

Participants receive NM32-2668 to further evaluate safety and obtain preliminary evidence of clinical activity

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NM32-2668

Trial Overview NM32-2668 is being tested for safety and effectiveness in treating selected advanced solid tumors. This early-phase trial will determine the best dose and gather initial data on how well it works.

How Is the Trial Designed?

Group I: NM32-2668 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Numab Therapeutics AG

Lead Sponsor

Trials

3

Recruited

360+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06299163

Study Details | NCT06299163 | NM32-2668 in Adult ... This is a first-in-human, open-label, multi-center, Phase 1, dose-escalation study with expansion cohorts to evaluate NM32-2668 for safety and ...

2. biospace.com biospace.com/press-releases/numab-therapeutics-announces-initiation-of-phase-1-clinical-study-of-nm32-program-in-patients-with-solid-tumors

Numab Therapeutics Announces Initiation of Phase 1 ... Generated preclinical data in non-human primates indicate a high potency and an excellent safety profile. About NM32 (NM32-2668) NM32 is a ...

3. synapse.patsnap.com synapse.patsnap.com/article/numab-therapeutics-begins-phase-1-study-of-nm32-in-solid-tumor-patients

Numab Therapeutics Begins Phase 1 Study of NM32 in ... The trial marks a significant step in the development of NM32, which leverages Numab's proprietary Lambda-cap and MATCH technology platforms.

4. numab.com numab.com/wp-content/uploads/211112_SITC_NM32-2668_Poster_FINAL.pdf

A trispecific ROR1xCD3xHSA T cell engager mediates in ... Treatment with NM32-2668 results in tumor eradication in a mantle cell lymphoma model ... Data depicted are one of four independent donors/experiments. 10.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10107375/

Recent progress in DNA methyltransferase inhibitors as ... A total of 20 patients with advanced solid tumor had a stable disease plateau between 1.4 and 13.3 months and their CT results showed that the tumor volume ...

6. jitc.bmj.com jitc.bmj.com/content/9/Suppl_2/A885

844 A trispecific ROR1 x CD3 T cell engager mediates in ... Our results demonstrate that NM32-2668 promotes ROR1 dependent T cell activation and proliferation, as well as T cell-mediated tumor cell lysis.