Study of ASN004 in Patients With Advanced Solid Tumors

NCT04410224 | Completed Phase 1 FDA Drug

• 1 other identifier: ASN004-101
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

Brief Summary

Participants in this study will receive ASN004 once every 3 or 4 weeks by intravenous infusion. The ASN004 dosing schedule may be modified based on emerging data and Safety Review Committee decision. The study will test various doses of ASN004 to find out the highest safe dose to test in future trials. Eligible subjects will be sequentially enrolled in cohorts at escalated doses.

Conditions

Solid Tumor

Keywords

antibody-drug conjugate; immunoconjugate; General Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Determine the maximum tolerated dose of ASN004

  The MTD will be determined by evaluating the number of subjects with treatment related adverse events (AEs) and DLTs.

  first 21 days for patients administered ASN004 every 3 weeks, and first 28 days for patients administered ASN004 every 4 weeks

Secondary Outcomes (6)

• Calculate the pharmacokinetic (PK) area under the plasma concentration of ASN004

  First 63 days

• Calculate the maximum plasma concentration at steady state

  First 63 days

• Calculate the terminal elimination rate of ASN004

  First 63 days

• Change in the size of measurable tumor lesions

  up to 1 year

• Change in the status of non-measurable tumor lesions

  Up to 1 year

Other Outcomes (1)

• Correlate 5T4 oncofetal protein (5T4) expression and clinical efficacy

  Up to 1 year

Study Arms (1)

ASN004 ascending doses

EXPERIMENTAL

Patients will receive escalating doses of ASN004 to identify the best dose for further study.

Drug: ASN004

Interventions

ASN004 DRUG

ASN004 is an antibody-drug conjugate for the treatment of advanced or metastatic solid tumors.

ASN004 ascending doses

Eligibility Criteria

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

You may qualify if:

• Provide written, voluntary informed consent prior to any -study specific procedure.
• Histologically confirmed diagnosis of advanced malignant solid tumor.
• All patients must agree to provide fresh or archival tumor tissue from the tumor lesion that has not been previously irradiated. Patients without archival tissue may only be enrolled if the patient consents to a screening biopsy and this procedure may be safely performed in the judgment of the Investigator.
• Evidence of progressive disease.
• For Dose Expansion patients, eligible tumor histologies will be limited to those malignancies known to have highest expression of 5T4 including colorectal, breast, ovarian, lung, liver, and renal carcinomas. A maximum of 3 prior cytotoxic chemotherapy regimens is permitted for advanced disease.
• Failure of standard therapy or no standard therapy available.
• Presence of at least 1 measurable target lesion by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 excluding previously irradiated lesions, bone metastasis, or pleural effusion as sole manifestations of disease. Dose escalation patients with evaluable (non-measurable) disease may be permitted to enroll with Medical Monitor approval.
• Age of at least 18 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• A male patient must agree to use contraception as detailed in this protocol during the treatment period and for at least 3 months after the last dose of study treatment and refrain from donating sperm during this period.
• A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies.
• i. Not a woman of childbearing potential (WOCBP) OR ii. A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of study treatment.
• Adequate organ function.
• Patients with Mandatory 5T4 Expression: Patients replacing a previously enrolled non-5T4 expressing patient must consent to and provide fresh or archival tumor tissue to the central pathology laboratory for 5T4 immunohistochemistry (IHC) testing. To be eligible, the patient's tumor must be confirmed by the central pathology laboratory to express 5T4 (H score of ≥ 10).
• Patient is willing and able to comply with all protocol required visits and assessments.

You may not qualify if:

• Hematologic malignancies and lymphomas.
• Patients with known brain metastases unless the patient has a single lesion or multiple lesions whose sum of the longest diameter is ≤ 1 cm AND who are asymptomatic.
• Serious concurrent medical conditions.
• Patients with known history of left ventricular ejection fraction of \< 50%.

Sponsors & Collaborators

• Kirilys Therapeutics Inc.: lead

Study Sites (4)

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

NEXT Oncology

Austin, Texas, 78758, United States

Location

NEXT Oncology

San Antonio, Texas, 78240, United States

Location

Next Oncology

Fairfax, Virginia, 22031, United States

Location

Study Officials

• Alison L Hannah, MD

  Kirilys Therapeutics Inc.

  STUDY DIRECTOR

Study Design

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

Model Details: Escalating doses of ASN004

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: April 8, 2022
• Primary Completion: May 8, 2024
• Study Completion: May 8, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)