CLN-418 Study on Subjects With Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

Official title:

A Phase 1 Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CLN-418 in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05306444
• Other study ID #: CLN-418-001
• Status: Recruiting
• Phase: Phase 1
• Start date: May 12, 2022
• Est. completion date: June 2024

Study information

• Verified date: December 2023
• Source: Cullinan Oncology Inc.
• Contact: Meagan Sardinha
• Phone: +1-617-410-4650
• Email: ClinOps[@]cullinanoncology.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study to evaluate the safety and tolerability of the study drug CLN-418, to determine the maximum tolerated dose and/or recommended Phase 2 study dose of CLN-418.

Description:

This is a study to evaluate the safety and tolerability of the study drug CLN-418, and to determine the maximum tolerated dose and/or recommended Phase 2 study dose of CLN-418.

The study will also look at the anti-tumor activity, pharmacokinetics and immunogenicity of CLN-418.The study consists of 2 parts. In Part 1, patients are enrolled into different cohort doses in order to identify the appropriate recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD). In Part 2, participants with metastatic / unresectable Non small cell lung cancer (NSCLC), Triple Negative Breast Cancer (TNBC) will receive the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) established in Part 1 of the study. In Part 1 and Part 2, participants will be administered treatment every 3 weeks.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Willingness to sign a written informed consent document.

2. Male or female subject aged =18 years old at the time of screening.

3. Histologically or cytologically confirmed advanced solid tumors (e.g., breast cancer, ovarian cancer, endometrial cancer, cervical cancer, squamous cell non-small cell lung cancer (sNSCLC), cholangiocarcinoma, esophagus cancer, urothelial carcinoma, head and neck squamous cell carcinoma (HNSCC)), followed by dose-expansion cohorts (Part 2) of subjects with advanced and/or metastatic non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC).or recurrent and progressed since last antitumor therapy for which no alternative, curative standard therapy exists.

4. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Prior used anti-B7H4 and/or anti-4-1BB antibody treatment.

2. Immuno-oncology therapy or targeted anti-cancer therapy within 4 weeks prior to first dose of investigational product, any other anti-cancer therapy within 2 weeks prior to first dose of investigational product.

3. Not yet recovered from surgery or (immune-related) toxicity related with previous treatment.

4. Known history or active infection of hepatitis B or C.

5. History of cirrhosis or non-alcohol steatohepatitis, alcohol or drug-related, autoimmune hepatitis.

6. Known brain metastases or other central nervous system metastases that are either symptomatic or untreated that require concurrent treatment.

7. Active infection that requires treatment with antibiotics or antiviral treatment within 3 weeks prior to first dose of investigational product.

8. Known history of infection with human immunodeficiency virus or known acquired immunodeficiency syndrome (AIDS).

9. Known autoimmune disease.

10. Clinically significant cardiac condition.

11. Pregnant or breastfeeding women.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• CLN-418
Intravenous (IV) administration

Locations

Country	Name	City	State
Australia	St George Private Hospital	Kogarah	New South Wales
Australia	Southern Medical Day Care Centre	Wollongong	New South Wales
United States	MD Anderson	Houston	Texas
United States	Carolina BioOncology Institute - Cancer Research Centre	Huntersville	North Carolina
United States	NEXT Oncology	Irving	Texas
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	Florida Cancer Specialists	Sarasota	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Cullinan Oncology Inc.	Harbour BioMed US, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with dose-limiting toxicity (DLT)	Number of subjects who experienced DLT events during 21 days after first administration of CLN-418, divided by the number of DLT evaluable Subjects	From Day 1 until day 21
Secondary	Adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0	Number of participants with Adverse Events (including vital signs, physical examinations, and abnormal laboratory parameters).	From signing of Informed Consent Form (ICF) till 84 days after last dose
Secondary	Objective response rate, defined as the proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1	Proportion of subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1	From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Secondary	Duration of response	The time interval from first occurrence of a documented objective response to the time of disease progression as determined by the Investigator using RECIST 1.1 or death from any cause, whichever comes first.	From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Secondary	Disease control rate	The proportion of subjects with a best overall response of Complete Response (CR), Partial Response (PR), or stable disease (SD).	From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months.
Secondary	Duration of disease control	The time from the date of start of treatment to the date of disease progression or death for subjects who had CR or PR or SD during treatment	From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months.
Secondary	Maximal tumor shrinkage	The greatest tumor shrinkage achieved at any follow-up assessment	From time of consent until the first documented disease progression, unacceptable toxicity, withdrawal of consent, lack of treatment benefits, death or study termination whichever comes first, assessed up to 12 months
Secondary	Pharmacokinetics Analysis - Serum Concentration	Reporting of serum concentration of CLN-418	Up to 84 days post last dose
Secondary	Anti-drug antibodies	Measure of detectable Anti-drug antibody (ADA) and neutralizing antibodies in serum samples at specific study timepoints	Up to 84 days post last dose
Secondary	Pharmacokinetics Analysis - Time Deviation	Reporting time deviation data of CLN-418	Up to 84 days post last dose