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

NCT06787950 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: YHGT-ASN-3186-ST-101
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• phase1:PK characteristics

  14 months

• phase1: QT/QTc

  14 months

• phase1: ECG

  14 months

• phase1+2a：AE

  28 days after the last administration

• phase1+2a：Serious adverse events (SAE)

  28 days after the last administration

Study Arms (3)

Dose Escalation

EXPERIMENTAL

Participants will receive ASN-3186 in sequential cohorts of increasing doses.

Drug: ASN-3186

Dose Expansion

EXPERIMENTAL

Recommended doses from dose escalation stage will be studied to determine RP2D.

Drug: ASN-3186

Tumor-specific Cohort Expansion

EXPERIMENTAL

RP2D will be further studied in tumor-specific cohorts.

Drug: ASN-3186

Interventions

ASN-3186 DRUG

ASN-3186 will be administered orally.

Tumor-specific Cohort Expansion

Eligibility Criteria

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

You may qualify if:

• 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.
• Life expectancy ≥12 weeks evaluated by investigator.
• ECOG Performance Score 0 to 2.
• 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.
• For Phase Ib subjects: Subjects must have confirmed deleterious or suspected deleterious germline or somatic BRCAm, or HRRm, or HRD positive or other alterations.
• For Phase IIa subjects: Subjects must have confirmed deleterious or suspected deleterious germline or somatic BRCAm, or HRRm, or HRD positive or other alterations.

You may not qualify if:

• ． Treatment with any of the following:
• Prior treatment with any USP1 inhibitors.
• Prior treatment with radiotherapy, chemotherapy, targeted therapy or endocrine therapy within 4 weeks prior to the first dose of ASN-3186.
• 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.
• ．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.

Sponsors & Collaborators

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

Central Study Contacts

Zijia Wang

CONTACT

+86-021-68583863; zjwang@asieris.cn

Study Design

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

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: January 22, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): March 20, 2029
• Study Completion (Estimated): September 20, 2029
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share