Zipalertinib for Non-Small Cell Lung Cancer

(REZILIENT1 Trial)

Recruiting at 74 trial locations

Overseen By Danny Nguyen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 1 & 2

Sponsor: Cullinan Therapeutics Inc.

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

Compensation: Varies

Number of Visits: Unknown

284 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing CLN-081, a new drug, in patients with a specific type of lung cancer that has a genetic mutation. The drug aims to block a protein that helps cancer cells grow, to see if it can slow down or stop the cancer.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain medications, including those that affect gastrointestinal motility or gastric pH, and any drugs that are inhibitors or inducers of specific enzymes, at least 14 to 28 days before starting the study drug. It's best to discuss your current medications with the trial team to see if any need to be paused.

Research Team

Zosia Piotrowska, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults with advanced non-small cell lung cancer (NSCLC) that has a specific mutation called EGFR exon 20 insertion. Participants can be new to treatment or have had certain prior therapies, but not treatments targeting this specific mutation or CLN-081. They should be able to do light work and must not currently smoke or have used tobacco recently.

Inclusion Criteria

My cancer has a specific EGFR mutation confirmed by a certified test.

I have been treated with a drug approved for EGFR ex20ins mutant NSCLC.

I have advanced or metastatic non-small cell lung cancer.

Exclusion Criteria

I was hospitalized for lung problems due to COVID-19.

I haven't taken EGFR inhibitors for at least 8 days before starting the study drug.

I have a history of lung conditions not related to infections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 Dose Escalation

Determine the safety, tolerability, and preliminary anti-tumor activity of CLN-081 monotherapy in dose escalation cohorts

24 months

Phase 2a Dose Expansion

Evaluate the safety and efficacy of CLN-081 monotherapy in expansion cohorts

24 months

Module A

Preliminarily assess the effect of food on the PK profile of CLN-081

24 months

Module B

Further characterize the safety and efficacy of CLN-081 monotherapy in patients with prior systemic anti-cancer treatment

24 months

Module C

Explore the safety, tolerability, and efficacy of CLN-081 monotherapy in patients with prior treatment with an agent approved for EGFR exon 20 insertion mutant NSCLC

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CLN-081

Trial Overview The study is testing the safety and effectiveness of a drug named CLN-081 in patients with NSCLC who have the EGFR exon 20 insertion mutation. It's an early-stage trial aiming to find the best dose for Phase 2 and see how well it works against this type of lung cancer.

Participant Groups

Group I: Phase 2a Dose Expansion(s) Experimental Treatment 1 Intervention

CLN-081 BID in expansion cohorts that may be opened at doses that meet pre-specified efficacy and safety criteria.

Group II: Phase 1 Dose Escalation (Rolling Six) Experimental Treatment 1 Intervention

CLN-081 BID in Rolling Six dose escalation cohorts enrolling NSCLC patients with EGFR exon 20 insertion mutations.

Group III: Phase 1 Dose Escalation (Accelerated Titration) Experimental Treatment 1 Intervention

CLN-081 BID in single patient dose escalation cohorts enrolling NSCLC patients with EGFR exon 20 insertion mutations that either have received or never received prior EGFR TKIs.

Group IV: Module C Experimental Treatment 1 Intervention

CLN-081 BID to patients with EGFR exon 20 insertion mutant NSCLC after prior therapy with an agent approved for the treatment of ex20ins mutant NSCLC.

Group V: Module B Experimental Treatment 1 Intervention

CLN-081 BID in NSCLC patients with EGFR exon 20 insertion mutations that have received prior systemic therapy for locally advanced or metastatic disease.

Group VI: Module A Food Affect Experimental Treatment 1 Intervention

Single-dose CLN-081 150 mg with and without high fat food intake.

Who Is Running the Clinical Trial?

Cullinan Therapeutics Inc.

Lead Sponsor

Trials

9

Recruited

1,000+

Cullinan Pearl

Lead Sponsor

Trials

1

Recruited

280+

Cullinan Oncology, LLC

Lead Sponsor

Trials

7

Recruited

990+