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Advanced Solid TumorsPhase 1/2NCT06787950

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

A Phase 1/2 study testing ASN-3186 in people with Advanced Solid Tumors, run by Jiangsu Yahong Meditech Co., Ltd aka Asieris.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
ASN-3186
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
20 Feb 2025to 20 Sep 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zijia Wang contact

+86-021-68583863

zjwang@asieris.cn

About this study

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.

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

Being tested
ASN-3186

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASN-3186Drug

    ASN-3186 will be administered orally.

  • ASN-3186Drug

    ASN-3186 will be administered orally.

  • ASN-3186Drug

    ASN-3186 will be administered orally.

Study groups in NCT06787950
Study groupRoleWhat they receive
Dose EscalationExperimentalParticipants will receive ASN-3186 in sequential cohorts of increasing doses.
Receives: Drug: ASN-3186
Dose ExpansionExperimentalRecommended doses from dose escalation stage will be studied to determine RP2D.
Receives: Drug: ASN-3186
Tumor-specific Cohort ExpansionExperimentalRP2D will be further studied in tumor-specific cohorts.
Receives: Drug: ASN-3186

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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),

    Measured: During the first 26 Days

  2. 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

    Measured: 14 months

  3. phase 2a: ORR

    ORR assessed by investigators.

    Measured: 26 months

Secondary outcomes (11)

  1. phase1:PK characteristics

    Plasma PK characteristics and metabolite PK characteristics of ASN-3186 after single or multiple oral administration

    Measured: 14 months

  2. phase1: QT/QTc

    To evaluate the effect of ASN-3186 on QT/QTc interval in patients with advanced solid tumors

    Measured: 14 months

  3. phase1: ECG

    To evaluate other electrocardiogram(ECG) parameters of ASN-3186 in patients with advanced solid tumors

    Measured: 14 months

  4. phase1+2a：AE

    The occurrence of all adverse events (AE).

    Measured: 28 days after the last administration

  5. phase1+2a：Serious adverse events (SAE)

    The occurrence of all serious adverse events (SAE)

    Measured: 28 days after the last administration

  6. phase1+2a: Disease Control Rate（DCR）

    Disease Control Rate defined as the rate of CR+PR+SD

    Measured: 14months

  7. 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

    Measured: 14 months

  8. 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

    Measured: 14 months

  9. phase1+2a: PFS

    progression-free survival(PFS): From the date of first study treatment to the time of disease progression or all-cause death

    Measured: 14 months

  10. phase1+2a: OS

    overall survival(OS):From the date of first study treatment to the time of all-cause death

    Measured: 14 months

  11. phase1+2a: biomarker

    Relationship between biomarker and efficacy

    Measured: 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2025
  2. Study start20 Feb 2025 (estimated)
  3. Primary completion20 Mar 2029 (estimated)
  4. Study completion20 Sep 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06787950
Sponsor's protocol ID
YHGT-ASN-3186-ST-101
Status last verified
Jan 2025
First submitted
5 Dec 2024
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ASN-3186 in people with Advanced Solid Tumors, run by Jiangsu Yahong Meditech Co., Ltd aka Asieris.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zijia Wang (+86-021-68583863, zjwang@asieris.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

phase 1( Dose Escalation Stage): Dose Limiting Toxicity (DLT) (time frame: During the first 26 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06787950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.

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