CLN-418 Study on Subjects With Advanced Solid Tumors

NCT05306444 | Completed Phase 1 FDA Drug

• 1 other identifier: CLN-418-001
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Advanced Solid Tumor

Keywords

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

  From signing of Informed Consent Form (ICF) till 84 days after last dose

• 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

  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

• Duration of response

  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

• Disease control rate

  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.

• Duration of disease control

  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.

Study Arms (2)

CLN-418: Part 1

EXPERIMENTAL

Experimental Part 1: Dose escalation Intravenous IV administrations of CLN-418 on Day 1 of each 21 day treatment cycle Dose for cohorts to be confirmed following consultation and approval by Safety Review Committee

Drug: CLN-418

CLN-418: Part 2

EXPERIMENTAL

Experimental Part 2: Dose Expansion Treatment administered at Maximum Tolerated Dose (MTD) and / or Recommended Phase 2 Dose (RP2D) established in Part 1

Drug: CLN-418

Interventions

CLN-418 DRUG

Intravenous (IV) administration

Also known as: HBM7008

CLN-418: Part 1; CLN-418: Part 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to sign a written informed consent document.
• Male or female subject aged ≥18 years old at the time of screening.
• 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.
• Adequate organ and bone marrow function.

You may not qualify if:

• Prior used anti-B7H4 and/or anti-4-1BB antibody treatment.
• 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.
• Not yet recovered from surgery or (immune-related) toxicity related with previous treatment.
• Known history or active infection of hepatitis B or C.
• History of cirrhosis or non-alcohol steatohepatitis, alcohol or drug-related, autoimmune hepatitis.
• Known brain metastases or other central nervous system metastases that are either symptomatic or untreated that require concurrent treatment.
• Active infection that requires treatment with antibiotics or antiviral treatment within 3 weeks prior to first dose of investigational product.
• Known history of infection with human immunodeficiency virus or known acquired immunodeficiency syndrome (AIDS).
• Known autoimmune disease.
• Clinically significant cardiac condition.
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• Harbour BioMed US, Inc.: lead

Study Sites (7)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Florida Cancer Specialists

Sarasota, Florida, 34232, United States

Location

Carolina BioOncology Institute - Cancer Research Centre

Huntersville, North Carolina, 28078, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

NEXT Oncology

Irving, Texas, 75039, United States

Location

St George Private Hospital

Kogarah, New South Wales, 2217, Australia

Location

Southern Medical Day Care Centre

Wollongong, New South Wales, 2500, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation (Part 1) followed by Dose expansion (Part 2)

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: April 1, 2022
• Study Start: May 12, 2022
• Primary Completion: August 28, 2024
• Study Completion: September 10, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5); AU (2)