NM32-2668 for Advanced Cancer

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

11 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 immunogenicity, to determine the maximal tolerated dose and recommended Phase 2 dose, define the pharmacokinetics, to explore the pharmacodynamics, and to obtain preliminary evidence of the clinical activity in adult patients with selected advanced solid tumors.

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.

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 haven't had extensive radiation therapy recently or am recovered from its side effects.

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+