Clinical Study of ASN-3186 in Patients with Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ASN-3186, ASN-3186, ASN-3186.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Anti-tumor Activity of ASN-3186 in Patients with Advanced Solid Tumors.
Overview
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
Interventions
- Drug ASN-3186
ASN-3186 will be administered orally. - Drug ASN-3186
ASN-3186 will be administered orally. - Drug ASN-3186
ASN-3186 will be administered orally.
Primary outcome measures
- phase 1( Dose Escalation Stage): Dose Limiting Toxicity (DLT) [Time frame: During the first 26 Days]
- phase 1( Dose Escalation Stage): Recommended phase 2 dose(RP2D) [Time frame: 14 months]
- phase 2a: ORR [Time frame: 26 months]
Secondary outcome measures (11)
- phase1:PK characteristics [Time frame: 14 months]
- phase1: QT/QTc [Time frame: 14 months]
- phase1: ECG [Time frame: 14 months]
- phase1+2a：AE [Time frame: 28 days after the last administration]
- phase1+2a：Serious adverse events (SAE) [Time frame: 28 days after the last administration]
- phase1+2a: Disease Control Rate（DCR） [Time frame: 14months]
- phase1+2a： DOR [Time frame: 14 months]
- phase1+2a: CBR [Time frame: 14 months]
- phase1+2a: PFS [Time frame: 14 months]
- phase1+2a: OS [Time frame: 14 months]
- phase1+2a: biomarker [Time frame: 14 months]
Eligibility criteria
Inclusion criteria
- 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 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.
- 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.
Exclusion criteria
1． 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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06787950 · YHGT-ASN-3186-ST-101