NM32-2668 for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Numab Therapeutics AG

Must not be taking: ROR1 agents, CD3 therapies

Disqualifiers: CAR therapy, Recent radiotherapy, others

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

+1 more

Trial Timeline

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

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: NM32-2668Experimental Treatment1 Intervention