Clinical Study of ASN-3186 in Patients with Advanced Solid Tumors

A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Anti-tumor Activity of ASN-3186 in Patients with Advanced Solid Tumors.

This is a Phase I/IIa, open-label, multi-center, dose-escalation, and expansion study to evaluate the safety, tolerability, PK and preliminary anti-tumor activity of ASN-3186 when given orally in subjects with advanced solid tumors

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: ASN-3186

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Zijia Wang; Phone Number: +86-021-68583863; Email: zjwang@asieris.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. Males or females aged ≥ 18 years at time of signing informed consent form (ICF). Signed ICF must be obtained before the performance of any protocol-specified procedures.
2. Life expectancy ≥12 weeks evaluated by investigator.
3. ECOG Performance Score 0 to 2.
4. Histologically or cytologically confirmed advanced solid tumors defined as unresectable locally advanced or metastatic and do not have standard treatment available, or have disease progression on/after standard treatment, or cannot tolerate standard treatment.
5. For Phase Ia subjects: Subjects who have confirmed deleterious or suspected deleterious germline or somatic BRCAm, or HRRm, or HRD positive or other alterations are preferred, but gene alteration state is not mandatory as an inclusion criterion and no need to wait for biomarker detection results before enrollment.
6. For Phase Ib subjects: Subjects must have confirmed deleterious or suspected deleterious germline or somatic BRCAm, or HRRm, or HRD positive or other alterations.
7. For Phase IIa subjects: Subjects must have confirmed deleterious or suspected deleterious germline or somatic BRCAm, or HRRm, or HRD positive or other alterations.

Key Exclusion Criteria:

1． Treatment with any of the following:

1. . Prior treatment with any USP1 inhibitors.
2. . Prior treatment with radiotherapy, chemotherapy, targeted therapy or endocrine therapy within 4 weeks prior to the first dose of ASN-3186.
3. . Participated and received investigational therapy or used an investigational device or participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks or 5 × t1/2, whichever is longer, prior to the first dose of ASN-3186.

2．Subjects who expect to require any other form of anti-tumor therapy during the treatment period. 3． Subjects who have unresolved toxicity greater than common terminology CTCAE V5.0 Grade 1 from prior anti-tumor therapy prior to the first dose of ASN-3186, except for alopecia and chemotherapy-induced peripheral neurotoxicity ≤ CTCAE V5.0 Grade 2. 4． Subjects who have undergone surgery on vital organs (other than aspiration biopsy) or suffered major trauma within 4 weeks prior to the first dose, or subjects who have not recovered from any surgical effect at screening, or subjects who are scheduled for major surgery during the study period. 5． Subjects who have gastrointestinal disorders that will affect oral administration or affect the absorption of ASN-3186 as judged by the investigator. Or subjects who have severe or clinically significant gastrointestinal disease (e.g., refractory diarrhea, intractable vomiting, colitis, etc.) within 4 weeks prior to the first dose of ASN-3186 and did not recover to CTCAE V5.0 Grade 1.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation; Participants will receive ASN-3186 in sequential cohorts of increasing doses.	Drug: ASN-3186; ASN-3186 will be administered orally.
Experimental: Dose Expansion; Recommended doses from dose escalation stage will be studied to determine RP2D.	Drug: ASN-3186; ASN-3186 will be administered orally.
Experimental: Tumor-specific Cohort Expansion; RP2D will be further studied in tumor-specific cohorts.	Drug: ASN-3186; ASN-3186 will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
phase 1( Dose Escalation Stage): Dose Limiting Toxicity (DLT)	DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria),	During the first 26 Days
phase 1( Dose Escalation Stage): Recommended phase 2 dose(RP2D)	RP2D is recommended based on MTD, safety data , efficacy data, and clinical pharmacokinetic (PK) characteristics	14 months
phase 2a: ORR	ORR assessed by investigators.	26 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
phase1:PK characteristics	Plasma PK characteristics and metabolite PK characteristics of ASN-3186 after single or multiple oral administration	14 months
phase1: QT/QTc	To evaluate the effect of ASN-3186 on QT/QTc interval in patients with advanced solid tumors	14 months
phase1: ECG	To evaluate other electrocardiogram(ECG) parameters of ASN-3186 in patients with advanced solid tumors	14 months
phase1+2a：AE	The occurrence of all adverse events (AE).	28 days after the last administration
phase1+2a：Serious adverse events (SAE)	The occurrence of all serious adverse events (SAE)	28 days after the last administration
phase1+2a: Disease Control Rate（DCR）	Disease Control Rate defined as the rate of CR+PR+SD	14months
phase1+2a： DOR	duration of response(DoR）：The time during study treatment from the first tumor assessment of CR or PR to the first assessment of disease progression or all-cause death	14 months
phase1+2a: CBR	clinical benefit rate (CBR): Proportion of patients whose best response was observed to be CR, PR, or SD (duration ≥24 weeks) over the study period	14 months
phase1+2a: PFS	progression-free survival(PFS): From the date of first study treatment to the time of disease progression or all-cause death	14 months
phase1+2a: OS	overall survival(OS):From the date of first study treatment to the time of all-cause death	14 months
phase1+2a: biomarker	Relationship between biomarker and efficacy	14 months

Collaborators and Investigators

• Sponsor: Jiangsu Yahong Meditech Co., Ltd aka Asieris

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2025
• Primary Completion (Estimated): March 20, 2029
• Study Completion (Estimated): September 20, 2029

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: YHGT-ASN-3186-ST-101

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
• product manufactured in and exported from the U.S.: No