A Phase 1/2 Trial of CLN-081 in Patients With Non-Small Cell Lung Cancer (REZILIENT1)

April 24, 2024 updated by: Cullinan Therapeutics Inc.

A Phase 1/2, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Locally-Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations Who Have Previously Received Platinum-Based Systemic Chemotherapy

CLN-081-001 is a Phase 1/2, open label, multi-center study of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring EGFR (epidermal growth factor receptor) exon 20 insertion mutations, to characterize the safety, determine the recommended Phase 2 dose (RP2D), and evaluate efficacy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 1/2, open-label, multicenter, first-in-human trial to evaluate the safety and tolerability, PK, PD, and efficacy of CLN-081 in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations.

This trial is divided into multiple parts: Phase 1 Dose Escalation, Phase 2a Dose Expansion, Module A, Module B, and Module C.

The objectives of the dose escalation and dose expansion parts are to determine the safety, tolerability, recommended Phase 2 dose (RP2D), and preliminary anti-tumor activity of orally administered CLN-081 monotherapy.

The objective of Module A is to preliminarily assess the effect of food on the PK profile of CLN-081.

The objective of Module B is to further characterize the safety and efficacy of CLN-081 monotherapy in patients with EGFR exon 20 insertion mutation NSCLC who have received prior systemic anti-cancer treatment for locally advanced or metastatic disease.

The objective of Module C is to explore the safety, tolerability, and efficacy of CLN-081 monotherapy in patients with EGFR exon 20 insertion mutation NSCLC who have received prior treatment with an agent approved for EGFR exon 20 insertion mutant NSCLC

CLN-081 will be dosed twice daily (BID).

Study Type

Interventional

Enrollment (Estimated)

284

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jackie Bronicki
  • Phone Number: 617-410-4650

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Hong Kong University - Queen Mary Hospital
        • Principal Investigator:
          • Victor Ho-Fun Lee, MBBS
        • Contact:
  • Italy
      • Careggi, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Careggi
        • Contact:
        • Principal Investigator:
          • Lorenzo Antonuzzo, MD, PhD
      • Marche, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I
        • Principal Investigator:
          • Rossana Berardi, MD
        • Contact:
      • Meldola, Italy
        • Recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS
        • Contact:
        • Principal Investigator:
          • Angelo Delmonte, MD
      • Milano, Italy
        • Recruiting
        • IRCCS-Istituto Europeo di Oncologia
        • Contact:
        • Principal Investigator:
          • Antonio Passaro, MD, PhD
      • Modena, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Modena
        • Contact:
        • Principal Investigator:
          • Michela Maur, MD
      • Monza, Italy
        • Recruiting
        • San Gerardo Hospital
        • Principal Investigator:
          • Diego Cortinovis, MD
        • Contact:
      • Ravenna, Italy
        • Recruiting
        • Ospedale Santa Maria delle Croci
        • Contact:
        • Principal Investigator:
          • Chiara Bennati, MD
  • Japan
      • Chiba, Japan
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
        • Principal Investigator:
          • Shigeki Umemura, MD, PhD
      • Niigata, Japan
        • Recruiting
        • Niigata Cancer Center
        • Contact:
        • Principal Investigator:
          • Hiroshi Tanaka, MD, PhD
      • Osaka, Japan
        • Recruiting
        • Osaka International Cancer Institute
        • Contact:
        • Principal Investigator:
          • Nishino Kazumi, MD, PhD
      • Osaka, Japan
        • Recruiting
        • Osaka City General Hospital
        • Principal Investigator:
          • Haurko Daga
        • Contact:
      • Shizuoka, Japan
        • Recruiting
        • Shizuoka Cancer Center
        • Contact:
        • Principal Investigator:
          • Haruyasu Murakami, MD, PhD
      • Tokyo, Japan
        • Recruiting
        • National Cancer Center Hospital
        • Contact:
        • Principal Investigator:
          • Yuichiro Ohe, MD, PhD
      • Tokyo, Japan
        • Recruiting
        • The Cancer Institute Hospital of Japanese Foundation for Cancer Research
        • Contact:
        • Principal Investigator:
          • Satoru Kitazono, MD, PhD
  • Korea, Republic of
      • Goyang-si, Korea, Republic of
        • Recruiting
        • National Cancer Center
        • Contact:
        • Principal Investigator:
          • Ji-Youn Han, MD, PhD
      • Gyeonggi-do, Korea, Republic of
        • Recruiting
        • Seoul National University Bundang Hospital (SNUBH)
        • Principal Investigator:
          • Se Hyun Kim, MD
        • Contact:
      • Incheon, Korea, Republic of
        • Recruiting
        • Inha University Hospital
        • Contact:
        • Principal Investigator:
          • Jun Hyeok Lim, MD
      • Incheon, Korea, Republic of
        • Recruiting
        • Gachon University Gil Medical Center
        • Contact:
        • Principal Investigator:
          • Hee Kyung Ahn, MD
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • Se-Hoon Lee, MD, PhD
        • Contact:
      • Soeul, Korea, Republic of
        • Recruiting
        • Asan Medical Center (AMC)
        • Contact:
        • Principal Investigator:
          • Sang-we Kim
      • Soeul, Korea, Republic of
        • Recruiting
        • Korea University Guro Hospital
        • Principal Investigator:
          • Sung-Yong Lee
        • Contact:
      • Suwon-si, Korea, Republic of
        • Recruiting
        • Ajou University Hospital
        • Principal Investigator:
          • Hyun Woo Lee
        • Contact:
      • Suwon-si, Korea, Republic of
        • Recruiting
        • The Catholic University Of Korea St. Vincent's Hospital
        • Principal Investigator:
          • Byoung Yong Shim
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Recruiting
        • The Netherlands Cancer Institute (NKI)
        • Principal Investigator:
          • Gerrina Ruiter
        • Contact:
      • Leiden, Netherlands, 2333 ZA
        • Recruiting
        • Leiden University Medical Center
        • Principal Investigator:
          • Egbert Smit, MD, PhD
        • Contact:
  • Singapore
      • Singapore, Singapore, 169610
      • Singapore, Singapore, 138669
        • Recruiting
        • Singapore Clinical Research Institute
        • Principal Investigator:
          • Ross Soo, MBBS
        • Contact:
  • Spain
      • A Coruña, Spain
      • Barcelona, Spain
        • Recruiting
        • Hospital Universitario Vall d'Hebron
        • Contact:
        • Principal Investigator:
          • Enriqueta Felip Font, MD, PhD
      • Barcelona, Spain
        • Recruiting
        • Hospital Clinic i Provincial de Barcelona
        • Contact:
        • Principal Investigator:
          • Laura Mezquita Perez, MD, PhD
      • Barcelona, Spain
        • Recruiting
        • Institut Catala d'Oncologia l'Hospitalet
        • Contact:
        • Principal Investigator:
          • Ernesto Samuel Nadal Alforia, MD, PhD
      • Barcelona, Spain
        • Recruiting
        • Hospital Parc Tauli
        • Contact:
        • Principal Investigator:
          • Julia Giner Joaquin, MD
      • Barcelona, Spain
        • Recruiting
        • START Barcelona
        • Contact:
        • Principal Investigator:
          • Tatiana Hernandez, MD
      • Las Palmas, Spain
        • Recruiting
        • Complejo Hospitalario Universitario Insular Materno Infantil
        • Contact:
        • Principal Investigator:
          • Delvys Rodriguez Abreu, MD, PhD
      • Madrid, Spain
        • Recruiting
        • Hospital General Universitario Gregorio Maranon (HGUGM)
        • Principal Investigator:
          • Antonio Calles Blanco, MD
        • Contact:
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Puerta de Hierro de Majadahonda
        • Contact:
        • Principal Investigator:
          • Mariano Provencio Pulla, MD, PhD
      • Madrid, Spain
        • Recruiting
        • University Hospital Quironsalud Madrid
        • Principal Investigator:
          • Valentina Boni, MD
        • Contact:
      • Málaga, Spain
        • Recruiting
        • Hospital Regional Universitario de Málaga
        • Contact:
        • Principal Investigator:
          • Manual Cobo Dols, MD, PhD
      • Pamplona, Spain
        • Recruiting
        • Clinica Universidad de Navarra
        • Contact:
        • Principal Investigator:
          • Eduardo Castanon Alvarez, MD
      • Valencia, Spain
        • Recruiting
        • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
        • Contact:
        • Principal Investigator:
          • Oscar Juan Vidal, MD, PhD
  • Taiwan
      • Chiayi City, Taiwan
        • Recruiting
        • Chang Gung Medical Foundation Chiayi Chang Gung Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Yu-Ching Lin, MD, PhD
      • Taichung, Taiwan
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Tsung-Ying Yang, MD, PhD
      • Taichung, Taiwan
        • Recruiting
        • Chung Shan Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Gee-Chen Chang, MD, PhD
      • Taipei, Taiwan
        • Recruiting
        • Taipei Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Chao-Hua Chiu, MD
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Principal Investigator:
          • James Chin-Hsin Yang, MD
        • Contact:
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Recruiting
        • Pacific Cancer Medical Center, Inc
        • Contact:
        • Principal Investigator:
          • Veena Charu
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Principal Investigator:
          • Danny Nguyen, MD
        • Contact:
      • Irvine, California, United States, 92618
        • Recruiting
        • City of Hope At Irvine Lennar
        • Principal Investigator:
          • Danny Nguyen
        • Contact:
      • Long Beach, California, United States, 90813
        • Recruiting
        • Pacific Shores Medical Group
        • Principal Investigator:
          • Danny Nguyen, MD
        • Contact:
    • Florida
      • Orlando, Florida, United States, 32804
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Zosia Piotrowska, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health System - University Hospital
        • Principal Investigator:
          • Gregory Kalemkerian
        • Contact:
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Recruiting
        • Summit Medical Group PA
        • Contact:
        • Principal Investigator:
          • Sarada Gurubhagavatula
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
        • Principal Investigator:
          • Vamsidhar Velcheti, MD
        • Contact:
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Principal Investigator:
          • Helena Yu, MD
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Principal Investigator:
          • Catherine Shu, MD
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • New York University Langone Health
        • Principal Investigator:
          • Vamsidhar Velcheti, MD
        • Contact:
    • Ohio
      • Canton, Ohio, United States, 44701
        • Recruiting
        • Gabrail Cancer Center Research
        • Principal Investigator:
          • Nashat Y Gabrail, MD
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Cancer Center
        • Principal Investigator:
          • Rachel E Sanborn, MD
        • Contact:
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Oncology & Hematology Care Clinic-Westside
        • Principal Investigator:
          • Rachel Sanborn
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center
        • Contact:
        • Principal Investigator:
          • Timothy Burns, MD, PhD
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Principal Investigator:
          • John Wrangle, MD
        • Contact:
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  1. Histologically or cytologically confirmed locally advanced or metastatic NSCLC (all patients).
  2. Documented EGFR ex20ins mutation demonstrated by a validated test listed in Section 9.7 and performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified or equivalent laboratory (all patients other than Module A Food Effect PK Assessment Module). Institutions that don't have access to these tests should contact the sponsor for assistance.

  3. Prior treatment in the recurrent/metastatic disease setting including:

    1. A platinum-based chemotherapy regiment (or other chemotherapy regimen if platinum-based chemotherapy is contra-indicated)
    2. Any other approved standard therapy that is available to the patient, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient. In the case of a patient declining such therapy, documentation that the patient has been informed and declined should be documented in the medical record.
    3. No prior therapy is required for patients enrolled on Module A.
    4. Prior therapy with an agent approved by the local regulatory authorities for the treatment of EGFR ex20ins mutant NSCLC (Module C only).
  4. Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (except for patients enrolled on Module A).
  5. Age ≥ 18 years.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  7. Ability to take pills by mouth.

  8. Have the following laboratory values:

    1. Serum creatinine < 1.5 × upper limit of normal (ULN) or calculated creatinine clearance (CrCl) must be ≥ 50 mL/min/1.73 m2 (if calculated by Cockroft-Gault formula, the actual body weight must be used for CrCl unless body mass index [BMI] >30 kg/m2 then lean body weight must be used).
    2. Total bilirubin ≤ 1.5 × ULN unless prior history of Gilbert's syndrome.
    3. AST and ALT ≤ 2.5 × ULN, or ≤ 5 × ULN if due to liver involvement by tumor.
    4. Hemoglobin ≥ 9.0 g/dL in the absence of transfusion ≤ 14 days prior to the first dose of study drug on C1D1.
    5. Platelets ≥ 100 × 109 cells/L in the absence of transfusion <14 days prior to the first dose of study drug on Cycle 1 Day 1 (C1D1).
    6. Absolute neutrophil count ≥ 1.5 ×109 cells/L.
  9. For Module A patients only: patients must have a negative coronavirus disease 2019 (COVID-19) polymerase chain reaction test prior to enrolment.
  10. For Module B and Module C patients only: verification of suitable archived tumor tissue available at the participating center for biomarker analysis. A fresh biopsy is required if an archived sample is not available.
  11. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

R6, Phase 1 Expansion, Phase 2a, Module A and Module B Patients Only

  1. Prior treatment with an EGFR ex20ins -targeting drug (eg, including, but not limited to poziotinib, mobocertinib, amivantamab, DZD9008, BDTX-189).

    Note: enrolment of patients treated previously with EGFR ex20ins-targeting drugs allowed selectively during accelerated titration dose escalation and Module C only.

    Module A Food Effect PK Assessment Module patients only

  2. Conditions that compromise esophageal or gastrointestinal (GI) function, including esophageal, gastric, pancreatic, hepatobiliary, or small bowel carcinomas, or history of gastric resection.
  3. Recurrent diarrhea, nausea, or vomiting.

  4. Unable to refrain from or anticipates the use of:

    1. Any drug, including prescription and non-prescription medications, including drugs that change gastrointestinal motility (eg, loperamide) or gastric pH (eg, antacids, H2 antagonists, proton pump inhibitors), herbal remedies, or vitamin supplements within 14 days prior to the first dosing on Day 1 to follow-up.
    2. Any drugs known to be inhibitors or inducers of CYP3A enzymes and/or P-glycoprotein (P-gp), including St. John's Wort and grape fruit juice, within 28 days prior to the first dosing and throughout the PK assessment.
  5. Any allergies to the composition of the high fat meal.

  6. Patients who use tobacco products.

    All Patients

  7. History of COVID-19-related pneumonitis requiring hospitalization.
  8. History of COVID-19 infection within 4 weeks prior to enrolment, or clinically significant pulmonary symptoms related to prior COVID-19 pneumonitis.

  9. Treatment with any of the following:

    1. An EGFR TKI ≤ 8 days or 5 × the terminal phase t1/2, whichever is longer, prior to the first dose of study drug on C1D1.
    2. Systemic anticancer treatment (excluding EGFR-TKIs as described above) within 14 days prior to the first dose of study drug on C1D1.
    3. Immunotherapy ≤ 28 days prior to the first dose of study drug on C1D1.
    4. Radiotherapy < 28 days and palliative radiation ≤ 14 days prior to the first dose of study drug on C1D1. If irradiated, lesions must have demonstrated clear-cut progression prior to being eligible for evaluation as target lesions.
    5. Major surgery (excluding placement of vascular access) ≤ 28 days of the first dose of study drug on C1D1.
  10. Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the Investigator and Sponsor.
  11. Have known or suspected leptomeningeal metastasis. Have known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, treated with surgery and/or radiation (if clinically indicated), and has been stable without requiring escalating corticosteroids or anti-convulsant medications for at least four weeks prior to the first dose of study drug on C1D1.
  12. Prior therapy with CLN-081.
  13. Known hypersensitivity to CLN-081 or any drugs similar in structure or class.
  14. Past medical history of interstitial lung disease, drug-induced interstitial lung disease, treatment-related pneumonitis, or any evidence of clinically active interstitial lung disease.
  15. Cardiac conditions as follows: Patient has a history of congestive heart failure (CHF) Class III/IV according to the New York Heart Association (NYHA) Functional Classification or serious cardiac arrhythmias requiring treatment.
  16. Resting QTcF > 470 msec.
  17. Patient is unable to take drugs po due to disorders or diseases that may affect GI function, including but not limited to inflammatory bowel diseases (eg, Crohn's disease, ulcerative colitis) or malabsorption syndrome, or procedures that may affect gastrointestinal function, such as gastrectomy, enterectomy, or colectomy.
  18. Have any condition or illness that, in the opinion of the Investigator, might compromise patient safety or interfere with the evaluation of the safety of the drug.
  19. Pregnant or lactating females; females of child-bearing potential (FOCBP) must have a negative serum pregnancy test at within seven days prior to receiving study drug on C1D1. FOCBP and males with partners of child-bearing potential must agree to use adequate birth control (Section 16.3) throughout their participation and for six months following the last dose of study treatment.
  20. History of another primary malignancy within 2 years prior to starting study drug on C1D1, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ.
  21. Uncontrolled intercurrent illness including, but not limited to, uncompensated respiratory, cardiac, hepatic, or renal disease, active infection (including human immunodeficiency virus (HIV) and active clinical tuberculosis), or renal transplant; ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirements.
  22. For patients with a history of hepatitis B (HBV), negative PCR test is required. Patients with active hepatitis B (HBV) infection [as defined by a positive hepatitis B serum antigen (HBsAg) test and detectable HBV deoxyribonucleic acid (DNA)]. Patients ineligible due to detectable levels of HBV DNA at baseline may be rescreened for enrolment if their HBV DNA levels become undetectable after treatment with antiviral agents, and upon agreement between the Investigator and Sponsor.
  23. For patients with a history of hepatitis C, active infection as defined by a reactive hepatitis C virus (HCV) antibody test and detectable HCV ribonucleic acid (RNA).
  24. Active bleeding disorders.
  25. The patient is, in the Investigator's opinion, unable or unwilling to comply with the trial procedures.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 Dose Escalation (Accelerated Titration)
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.
Drug: CLN-081
CLN-081 tablets
Other Names:
  • TAS6417; zipalertinib
Experimental: Phase 1 Dose Escalation (Rolling Six)
CLN-081 BID in Rolling Six dose escalation cohorts enrolling NSCLC patients with EGFR exon 20 insertion mutations.
Drug: CLN-081
CLN-081 tablets
Other Names:
  • TAS6417; zipalertinib
Experimental: Module A Food Affect
Single-dose CLN-081 150 mg with and without high fat food intake.
Drug: CLN-081
CLN-081 tablets
Other Names:
  • TAS6417; zipalertinib
Experimental: Module B
CLN-081 BID in NSCLC patients with EGFR exon 20 insertion mutations that have received prior systemic therapy for locally advanced or metastatic disease.
Drug: CLN-081
CLN-081 tablets
Other Names:
  • TAS6417; zipalertinib
Experimental: Module C
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.
Drug: CLN-081
CLN-081 tablets
Other Names:
  • TAS6417; zipalertinib
Experimental: Phase 2a Dose Expansion(s)
CLN-081 BID in expansion cohorts that may be opened at doses that meet pre-specified efficacy and safety criteria.
Drug: CLN-081
CLN-081 tablets
Other Names:
  • TAS6417; zipalertinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All Cohorts: The rate and severity of treatment emergent AEs.
Time Frame: 24 months
24 months
All Cohorts: The rate and severity of DLTs.
Time Frame: 24 months
24 months
Phase 2 Dose Expansion Cohorts: Overall response rate (ORR)
Time Frame: 24 months
24 months
Module A: Pharmacokinetic (PK) parameter
Time Frame: 24 months
Maximum Plasma Concentration [Cmax]
24 months
Module A: Pharmacokinetic (PK) parameter
Time Frame: 24 months
Area Under Curve [AUC]
24 months
Module B and C: Confirmed overall response rate (ORR) and duration of response (DOR) by independent review committee (IRC)
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
All Cohorts: Assessment of maximum concentration (Cmax)
Time Frame: 24 months
24 months
All Cohorts: Assessment of area under curve (AUC)
Time Frame: 24 months
24 months
All Cohorts: Assessment of time to maximum concentration (tmax)
Time Frame: 24 months
24 months
All Cohorts: Assessment of terminal half-life (t1/2)
Time Frame: 24 months
24 months
Phase 1 Dose Escalation and Expansion, Phase 2a Dose Expansion, and Module B and C Cohorts: ORR by Investigator assessment
Time Frame: 24 months
24 months
Phase 1 Dose Escalation and Dose Expansion, Phase 2a Dose Expansion, and Module B and C Cohorts: DOR (duration of response).
Time Frame: 24 months
24 months
Phase 1 Dose Escalation and Dose Expansion, Phase 2a Dose Expansion, and Module B and C Cohorts: DCR (disease control rate)
Time Frame: 24 months
24 months
Phase 1 Dose Escalation and Dose Expansion, Phase 2a Dose Expansion, and Module B and C Cohorts: PFS (progression free survival)
Time Frame: 24 months
24 months
Phase 1 Dose Escalation and Dose Expansion, Phase 2a Dose Expansion, and Module B and C Cohorts: OS (overall survival)
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cullinan Therapeutics Inc.

Investigators

  • Study Chair: Zosia Piotrowska, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2019

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 23, 2019

First Submitted That Met QC Criteria

July 25, 2019

First Posted (Actual)

July 30, 2019

Study Record Updates

Last Update Posted (Estimated)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-081-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non Small Cell Lung Cancer

Clinical Trials on CLN-081

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe