Study of ASN004 in Patients With Advanced Solid Tumors

NCT ID: NCT04410224

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-08
• Study Completion Date: 2024-05-08

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.

Detailed Description

Eligible patients will be sequentially enrolled at escalating doses.

Dose escalation decisions will be based on the review of clinical safety and pharmacokinetic (PD) and pharmacodynamics (PD) data and agreed upon by the Sponsor and investigators.

The maximum tolerated dose (MTD) will have an estimated DLT rate of < 33%. Cohorts may be expanded at any dose level or at the MTD for further evaluation of safety, or PK parameters as required.

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASN004 ascending doses

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

Group Type: EXPERIMENTAL

ASN004

Intervention Type: DRUG

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

Interventions

ASN004

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Provide written, voluntary informed consent prior to any -study specific procedure.

2. Histologically confirmed diagnosis of advanced malignant solid tumor.

3. 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.

4. Evidence of progressive disease.

5. 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.

6. Failure of standard therapy or no standard therapy available.

7. 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.

8. Age of at least 18 years old.

9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

10. 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.

11. 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.

12. Adequate organ function.

13. 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).

14. Patient is willing and able to comply with all protocol required visits and assessments.

Exclusion Criteria

1. Hematologic malignancies and lymphomas.

2. 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.

3. Serious concurrent medical conditions.

4. Patients with known history of left ventricular ejection fraction of < 50%.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kirilys Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alison L Hannah, MD

Role: STUDY_DIRECTOR

Kirilys Therapeutics Inc.

Locations

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

NEXT Oncology

Austin, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Next Oncology

Fairfax, Virginia, United States

Countries

United States

Other Identifiers

ASN004-101

Identifier Type: -

Identifier Source: org_study_id